The reported issue was confirmed.The device was returned for evaluation.Visual inspection on the returned catheter found a pinhole on the rubberize layer of the inflation lumen, which caused the interlumen leak.Sample was examined under microscopic conditions and identified that this defect could have been contributed by the manufacturing process.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿[conraindications] 1.Method for use: 1) do not reuse.2) do not resterilize 3) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon] 4) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.] 2.Applicable patients 1) do not use in patients who are or have been allergic to natural rubber latex.".Section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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