MAUDE Adverse Event Report: DATASCOPE FAIRFIELD TRANS-RAY 7FR. 34CC IAB - JAPAN; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0513

Device Problem Material Rupture (1546)

Patient Problem Failure of Implant (1924)

Event Date 04/19/2018

Event Type  malfunction  

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.Complaint # (b)(4), record # (b)(4).

Event Description

It was reported that a day after intra-aortic balloon therapy began an iab rupture occurred.The iab was removed and therapy was discontinued.Severe sclerosis was noted in the patient vessel.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.The extension tubing was also returned.One kink was found on the catheter tubing approximately 76.2cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extension tubing was performed and one leak was detected on the membrane approximately 1.3cm from the rear seal measuring 0.015cm in length.The optical fiber was found to be broken within the catheter tubing approximately 76.5cm from iab tip.The evaluation confirms the reported leak, blood in tubing problem.The reported blood in tubing was most likely triggered by the leak which was found on the membrane.Under magnification, a whitish patch was observed around the leak on the membrane.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.Complaint # (b)(4).

Event Description

It was reported that a day after intra-aortic balloon therapy began an iab rupture occurred.The iab was removed and therapy was discontinued.Severe sclerosis was noted in the patient vessel.There was no reported injury to the patient.

• Brand Name: TRANS-RAY 7FR. 34CC IAB - JAPAN
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 7509747
• MDR Text Key: 108248692
• Report Number: 2248146-2018-00333
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2019
• Device Catalogue Number: 0684-00-0513
• Device Lot Number: 3000036484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1