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

Catalog Number 0684-00-0475

Device Problems Inflation Problem (1310); Aspiration Issue (2883)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/06/2018

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 the physician was not able to aspirate from the intra-aortic balloon (iab) immediately after insertion and it would not inflate.There was no reported injury to the patient.

Event Description

It was reported that the physician was not able to aspirate from the intra-aortic balloon (iab) immediately after insertion and it would not inflate.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood found on the exterior of the catheter.The guide wire was returned inside the iab inner lumen.The guide wire was removed from the iab inner lumen and the technician was able to successfully aspirate/flush the inner lumen.The technician then reinserted the returned 0.025¿ guide wire through the inner lumen and was able to successfully insert the guide wire.No obstructions were felt.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and the iab fully inflated.No alarm sounded from the pump.An evaluation of the product was unable to duplicate the reported problems.The product performed according to specification.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), record # (b)(4).

• Brand Name: LINEAR 7.5 FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 7483906
• MDR Text Key: 107354668
• Report Number: 2248146-2018-00301
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2020
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000057269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Device Age: YR
• Date Manufacturer Received: 05/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 88