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

Catalog Number 0684-00-0475

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 06/12/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The product was returned with the membrane completely unfolded with no blood visible on the catheter.A catheter tubing kink was observed near the y-fitting at approximately 76.5cm from the iab tip.The evaluation confirms the presence of a kink as an as analyzed failure.However, we are unable to conclusively determine when this kink may have occurred.Therefore, the root cause for the kink is impossible to define.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.(b)(4).

Event Description

During the investigation of the returned intra-aortic balloon (iab) involved under mfg report number 2248146-2020-00257, a kink was found that was unrelated to the reported leak failure mode.There was no patient involvement.

• Brand Name: LINEAR 7.5 FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: dorota wolpiuk ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 10236729
• MDR Text Key: 198012898
• Report Number: 2248146-2020-00335
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2020

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: 09/24/2022
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000104997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1