Cause of Device-Related Incident
Device factors; Support system failures; User errors

Clinical Specialty or Hospital Department
Cardiology / Cardiac Catheterization; CCU / ICU / NICU; Clinical/Biomedical Engineering; Nursing; OR / Surgery

Device Factors
Device failure

Document Type
Hazard Reports

External Factors
*Not stated

Mechanism of Injury or Death
Embolism (gaseous or particulate); Failure to deliver therapy

Support System Failures
Lack or failure of incoming and pre-use inspections; Use of inappropriate devices

Tampering and/or Sabotage
*Not stated

User Errors
Inappropriate reliance on an automated feature; Incorrect clinical use

UMDNS
Catheters, Intra-Aortic Balloon [10-725]; Circulatory Assist Units, Intra-Aortic Balloon [10-846]

Intra-Aortic Balloon Perforations (Update)



Hazard Update [Health Devices May 1997;26(5):217-9]

Problem Summary

In Health Devices 18(12), December 1989, ECRI published a Hazard Report addressing perforations of intra-aortic balloons (IABs). Although rare, balloon perforations are a recognized complication of intra-aortic balloon pump (IABP) therapy, and we continue to receive reports of perforations involving all brands of IABs. Therefore, we are updating the original Hazard Report to review the causes and possible serious consequences of IAB perforations, along with methods to minimize their incidence.

Discussion

Causes of Balloon Perforations

For safe and effective operation, an IAB must be inflated and deflated quickly and must be insertable through as narrow an arterial sheath as possible. To this end, the balloon membrane of an IAB is only a few thousandths of an inch thick, making it susceptible to abrasion and perforation.

Balloon perforations have several causes. Some patients (especially the elderly) have tortuous vessels lined with calcified atherosclerotic plaque. In our experience, IAB perforations can usually be traced to insertion of an IAB through these vessels and to repeated contact between the IAB and the calcified plaque as the balloon is inflated and deflated. These actions can cause abrasion and eventual perforation of the balloon's thin membrane. Other sources of perforation include manufacturing defects and abrasions and punctures that arise during handling.

Problems Stemming from Balloon Perforations

An IAB perforation can lead to the following problems, either of which can cause serious injury to the patient:

  • The IAB can become trapped within the aorta or femoral artery. This can occur when enough blood (i.e., several cubic centimeters) enters the balloon through a perforation to form a hard clot inside the balloon sufficiently large to prevent the balloon's removal.
  • Helium gas can leak into the bloodstream through a perforation in the balloon, possibly causing a gas embolus. However, this is very uncommon since 1.) most perforations in an IAB are minute and 2.) during inflation, the pressure gradient across the balloon membrane is too low to overcome the large surface tension at the balloon/blood interface. Instead, blood is more likely to enter the IAB; this happens during deflation, when the pressure gradient is greater and in the opposite direction.

Minimizing Perforations and Managing Their Complications

Two ways to minimize the incidence of IAB perforations are to 1) use the correct size balloon and 2) position it properly. Although IABs are now available in a variety of volumes (e.g., 30, 40, 50 cc), the standard 40 cc IAB is still generally used for all adult patients, regardless of their size. However, studies(1,2,3) show that using smaller IABs in shorter patients may reduce the incidence of IAB perforations.

Choosing an IAB to match the size of the patient helps ensure that the balloon can be properly placed—that is, that the tip of the IAB can be positioned below the subclavian artery while the proximal portion of the balloon membrane remains in the descending thoracic aorta and out of the abdominal aorta. This is important, since the abdominal aorta generally has more calcified plaque than does the descending thoracic aorta. Proper positioning of the IAB is crucial and should be verified radiographically or fluoroscopically.

Careful review of the instructions for balloon insertion and contraindications for use will also keep balloon perforations to a minimum.

Even when perforations do occur, careful observation by clinicians and immediate investigation of gas leak alarms from an IABP typically prevent serious injury to the patient. For example, if blood is seen in the extension tubing or in the balloon catheter, clinicians are instructed to discontinue pumping and remove the balloon immediately.

Recommendations

  1. Choose the balloon size that best matches the size of the patient (e.g., use smaller balloons for shorter patients).
  2. Verify proper positioning of the IAB within the aorta radiographically or fluoroscopically.
  3. While the IABP is in use, instruct staff to inspect the entire length of the IAB catheter and extension tubing for the presence of blood at least every two hours. If blood is seen in the catheter or tubing, the appropriate clinical staff should take action to safely discontinue operation and remove the balloon immediately.
  4. Investigate gas leak alarms from an IABP immediately.
  5. Consider the perforation of any balloon to be a warning that the patient's vasculature may cause perforations or abrasions in subsequent balloons. Therefore, if a balloon is perforated during use and an alternative therapeutic modality is unavailable or ineffective, increase the IAB catheter and extension tubing inspection frequency to every half hour for the next balloon that is inserted.
  6. Have clinicians review balloon insertion instructions before each use to verify that no changes have been made in the recommended procedure.

Notes

  1. Cohen M, Patel JJ, Dohad S, et al. Pilot prospective evaluation of counterpulsation with different intra-aortic balloon volumes on cardiac performance in humans. Cathet Cardiovasc Diagn 1995;36(1):82-7.
  2. Cox PM, Kellett M, Goran SF, et al. Plaque abrasion and intra-aortic balloon leak. Chest 1995 Dec;108(6):1495-8.
  3. Wolvek S. The hostile environment of the aging human aorta and the smaller patient--their implications for the intra-aortic balloon. Perfusion 1994 Mar;9(2):87-94.

UMDNS Terms

  • Catheters, Intra-Aortic Balloon [10-725]
  • Circulatory Assist Units, Intra-Aortic Balloon [10-846]

Cause of Device-Related Incident

Device factor: Device failure

User errors: Inappropriate reliance on an automated feature; Incorrect clinical use

Support system failures: Failure to train and/or credential; Use of inappropriate devices

Mechanism of Injury or Death

Embolism (gaseous); Failure to deliver therapy


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