MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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.

• Brand Name: MEGA 7.5FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 10585630
• MDR Text Key: 208504736
• Report Number: 2248146-2020-00508
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107974
• UDI-Public: 10607567107974
• Combination Product (y/n): N
• PMA/PMN Number: K120868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2022
• Device Model Number: 0684-00-0295-01
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: 3000110169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/25/2020
• Supplement Dates Manufacturer Received: 10/06/2020
• Supplement Dates FDA Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AUTOCAT2WAVE IABP; AUTOCAT2WAVE IABP
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 95