MAUDE Adverse Event Report: DATASCOPE FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0604

Device Problems Backflow (1064); Material Rupture (1546); Device Displays Incorrect Message (2591)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 12/12/2017

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.(b)(4).

Event Description

It was reported that on (b)(6) 2017 intra-aortic balloon (iab) was inserted on a patient.On (b)(6) 2017 during therapy a balloon rupture was noted.Also a gas gain in iab circuit alarm was generated and blood was found in the tubing.Mild calcification was noted in the vessel.Replaced iab to continue therapy.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the interior of the catheter.The extender tubing was also returned.Dried blood was found occluding the inner lumen.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and one leak was detected on the membrane approximately 1.3cm from the rear seal measuring 0.03cm in length.Two kinks were found on the catheter tubing approximately 44.7cm and 48.5cm from the iab tip.The evaluation confirmed the reported alarm, gas gain & leak and blood in tubing problem.The reported alarm, gas gain and blood in tubing 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).

Event Description

It was reported that on (b)(6) 2017 intra-aortic balloon (iab) was inserted on a patient.On (b)(6) 2017 during therapy a balloon rupture was noted.Also a gas gain in iab circuit alarm was generated and blood was found in the tubing.Mild calcification was noted in the vessel.Replaced iab to continue therapy.There was no reported injury to the patient.

• Brand Name: TRANS-RAY PLUS 7.5 FR. 35CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 7169469
• MDR Text Key: 97758515
• Report Number: 2248146-2018-00006
• 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
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/03/2020
• Device Catalogue Number: 0684-00-0604
• Device Lot Number: 3000046807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Device Age: YR
• Date Manufacturer Received: 01/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 61