Material Degradation of Angiographic Catheters
Hazard [Health Devices Oct 1995;24(10):421-2]
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.
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).
Hospitals should implement the following recommendations, along with those
supplied by the catheter manufacturer:
- 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
- Store all catheters in a dry, dark, room-temperature
cabinet or closet.
- Rotate inventory to ensure that the oldest catheters
are used first.
- 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.
- 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