MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0469-01

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 08/31/2020

Event Type  malfunction  

Manufacturer Narrative

The initial reporter named in block e1 is a getinge employee whose contact details are: (b)(6).Which differs from that of the event site.The device was returned cut in two parts with the membrane completely unfolded with blood on the interior of the catheter and between the catheter and the returned non-maquet sheath.The cut was made on the catheter tubing/inner lumen at approximately 71.6cm from the iab tip.A catheter tubing/inner lumen kink was also observed at approximately 0.3cm from the y-fitting.Additionally, the stat-gard sleeve was also cut/torn at approximately 6.1cm from the y-fitting.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.Reference complaint #(b)(4).

Event Description

During the investigation of the returned intra-aortic balloon (iab) involved under mfg report number 2248146-2020-00359, a kink was found that was unrelated to the reported leak failure mode.There was no patient involvement.

• Brand Name: SENSATION 7FR. 34CC 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: 10522213
• MDR Text Key: 219525252
• Report Number: 2248146-2020-00463
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567106755
• UDI-Public: 10607567106755
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• 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: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2021
• Device Model Number: 0684-00-0469-01
• Device Catalogue Number: 0684-00-0433
• Device Lot Number: 3000083429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2018
• 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