Model Number 0684-00-0295-01 |
Device Problem
Difficult to Remove (1528)
|
Patient Problem
Injury (2348)
|
Event Date 08/31/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
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
|
It was reported that after the console alarmed and blood was seen in the tubing, the physician assistant attempted to remove catheter but met resistance.Patient taken to surgery for removal of entrapped iab catheter and vessel repair.Patient did not require a replacement catheter.The insertion was reported to be axillary, which is not the method described in the device instructions for use.
|
|
Manufacturer Narrative
|
The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter.The extender tubing was also returned.Two kinks were found on the catheter tubing near the y-fitting approximately 75.2cm and 76.2cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and four leaks were detected on the membrane.One abrasion leak approximately 1cm from the rear seal measuring 0.013cm in length.Three sharp edge leaks approximately 15.5cm and (2) 21.6cm from the rear seal measuring 0.013cm, 0.635cm and 0.025cm in length.The condition of the returned product indicated catheter tubing kinks and membrane penetrations.One penetration found 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.Although we were unable to mimic the clinical setting for difficult to remove iab from the patient.The other three penetrations found on the membrane appear to have been caused by a sharp object.The sharp edge penetrations and the kinks found may have occurred during iab removal from the patient.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint # (b)(4).
|
|
Event Description
|
It was reported that after the console alarmed and blood was seen in the tubing, the physician assistant attempted to remove catheter but met resistance.Patient taken to surgery for removal of entrapped iab catheter and vessel repair.Patient did not require a replacement catheter.The insertion was reported to be axillary, which is not the method described in the device instructions for use.
|
|
Search Alerts/Recalls
|