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

Clinical Specialty or Hospital Department
Cardiology / Cardiac Catheterization; CSR / Materials Management; Nursing; OR / Surgery

Device Factors
Design / labeling error

Document Type
Hazard Reports

External Factors
*Not stated

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

Support System Failures
Improper storage

Tampering and/or Sabotage
*Not stated

User Errors
Failure to perform pre-use inspection

UMDNS
Catheters, Angiography [10-688]; Catheters, Arterial [10-689]; Catheters, Cardiac [10-698]

Material Degradation of Angiographic Catheters



Hazard [Health Devices Oct 1995;24(10):421-2]

Problem

Several member hospitals have reported instances of angiographic catheter degradation during storage. Catheters have been found to be discolored, brittle, or ruptured when removed from their protective packaging. In most cases, the degradation was readily apparent, but in rare instances, the catheters were used in patients and fractured during use. A degraded catheter that breaks in this manner can release irretrievable fragments into the arterial system.

Improper storage was cited as a contributing factor in most of the reported instances. Also, in some cases, the manufacturer's recommended expiration date may have been exceeded. (Note that, until a few years ago, these dates were not routinely printed on the packaging.) Material and manufacturing defects account for the remainder of the reported cases.

Discussion

Many medical products manufactured from rubber, plastic, and other polymers degrade over time. Exposure to heat, moisture, or ultraviolet light can hasten the process and render the product unusable even before the stamped expiration date. Angiographic catheters can be more prone to degradation than some other catheters, in part because they are manufactured with very thin, flexible walls so that they can be safely threaded through the arterial system. Proper storage techniques can minimize this degradation (see Recommendation No. 2, below).

Recommendations

Hospitals should implement the following recommendations, along with those supplied by the catheter manufacturer:

  1. Ensure that all catheter packaging is marked with an expiration date (i.e., "use before mm/yy"). Alternatively, the packaging may bear the date of manufacture, along with the life expectancy (i.e., "X years from mm/yy"). If none of this information appears, obtain it from the manufacturer, if possible, and mark the packaging accordingly.
  2. Store all catheters in a dry, dark, room-temperature cabinet or closet.
  3. Rotate inventory to ensure that the oldest catheters are used first.
  4. Inspect all catheters before use. Check that the expiration date has not passed. Examine all tubing, balloons, fittings, etc., to ensure that they have not degraded. Do not use any catheter that has become brittle or discolored or one for which the expiration date has been exceeded. Pay particular attention to catheters that may have been stored for extended periods (e.g., those kept in infrequently used special procedures rooms). Instruct all staff about these procedures.

UMDNS Terms

  • Catheters, Angiography [10-688]
  • Catheters, Arterial [10-689]
  • Catheters, Cardiac [10-698]

Cause of Device-Related Incident

Device factor: Design/labeling error

User error: Failure to perform pre-use inspection

Support system failure: Improper storage

Mechanism of Injury or Death

Embolism (particulate); Failure to deliver therapy


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