Catalog Number 0684-00-0575 |
Device Problem
Material Rupture (1546)
|
Patient Problem
Rupture (2208)
|
Event Date 03/25/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.(b)(4).
|
|
Event Description
|
Facility medwatch report mw507i6199 received for intra-aortic balloon stated that there was an "iabp rupture, right femoral artery access, prompting immediate removal of the balloon".The iab was removed.There was no reported injury to the patient.
|
|
Event Description
|
Facility medwatch report mw507i6199 received for intra-aortic balloon stated that there was an "iabp rupture, right femoral artery access, prompting immediate removal of the balloon".The iab was removed.There was no reported injury to the patient.
|
|
Manufacturer Narrative
|
The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter but it was not a maquet product.The extender tubing was also returned.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and one leak was detected on the membrane approximately 1.0cm from the rear seal measuring 0.03m in length.The optical fiber was found to be broken within the membrane approximately 26.4cm from the iab tip.The evaluation confirms the reported leak problem.The reported problem was most likely triggered by a leak which was found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.(b)(4).
|
|
Search Alerts/Recalls
|