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); Device Displays Incorrect Message (2591)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 09/27/2017

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 on (b)(6) 2017 during intra-aortic balloon (iab) insertion on ami patient, alarm ¿check iab catheter¿ was generated.Blood back run was noted in the iab.Severe sclerosis, tortuosity and calcification were noted in the patient vessel.Replaced iab to continue therapy.No patient injury was reported.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the exterior.No blood was observed inside the iab catheter.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing and extension tubing was performed and one leak was detected on the membrane approximately 15.5cm from the rear seal measuring 1.17cm in length.The evaluation confirms the reported alarm, check iab catheter, leak and blood in tubing.The reported alarm and blood in tubing was most likely triggered by a leak which was found on the membrane.The penetration found on the membrane appears to have been caused by a sharp object.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 on (b)(6) 2017 during intra-aortic balloon (iab) insertion on ami patient, alarm ¿check iab catheter¿ was generated.Blood back run was noted in the iab.Severe sclerosis, tortuosity and calcification were noted in the patient vessel.Replaced iab to continue therapy.No patient injury was reported.

• 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
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 6959694
• MDR Text Key: 90648082
• Report Number: 2248146-2017-00584
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/13/2020
• Device Catalogue Number: 0684-00-0604
• Device Lot Number: 3000043968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 09/29/2017
• Initial Date FDA Received: 10/18/2017
• Supplement Dates Manufacturer Received: 11/06/2017
• Supplement Dates FDA Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2017
• 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
• Patient Weight: 52