MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0474

Device Problems Break (1069); Display or Visual Feedback Problem (1184); Leak/Splash (1354); Defective Component (2292); Device Contamination with Body Fluid (2317)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/02/2019

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 after one hour of intra-aortic balloon (iab) therapy, the console generated a blood detect alarm and blood was noted in the iab.The customer removed the iab.After removal the central lumen of the iab was broken.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.A visual examination of the product detected the inner lumen within the membrane was completely separated within a kink approximately 24.1cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting, and extracorporeal tubing was performed and a leak was confirmed at the inner lumen separation.The break found in the inner lumen appears to have been the result of a severe kink, which eventually failed and allowed blood to leak into the membrane and catheter tubing causing the reported problems.It is difficult to determine when the break occurred but it is possibly a result of patient movement during the procedure.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); record id (b)(4).

Event Description

It was reported that after one hour of intra-aortic balloon (iab) therapy, the console generated a blood detect alarm and blood was noted in the iab.The customer removed the iab.After removal the central lumen of the iab was broken.There was no reported injury to the patient.

• Brand Name: LINEAR 7.5 FR. 34CC 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: 8539837
• MDR Text Key: 142901897
• Report Number: 2248146-2019-00311
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/31/2019

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: Health Professional
• Device Expiration Date: 06/08/2021
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000075437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Device Age: YR
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 04/23/2019
• Supplement Dates Manufacturer Received: 05/24/2019
• Supplement Dates FDA Received: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 48