MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP XTR CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number CDS0602-XTR

Device Problems Leak/Splash (1354); Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report a leak and material separation.It was reported that during preparation, air was noticed in delivery catheter (dc) handle.In an attempt to deair the device, the red cap was attempted to be removed from the dc flush port; however, the flush port broke and completely detached from the delivery catheter.It was noted that during preparation, all steps were performed per the instructions for use (ifu).The device was not used and was replaced.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The return device analysis observed the broken flush port luer.The reported leak could not be replicated in a testing environment due to the returned condition of the device (broken flush port luer).A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and the leak appears to be due to the reported broken flush port luer.The investigation determined the broken flush port luer to be related to product quality issue.The issue is being addressed per internal operation procedure.Abbott vascular (av) will continue to trend the performance of these devices.

• Brand Name: MITRACLIP XTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11089341
• MDR Text Key: 225807348
• Report Number: 2024168-2020-10974
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• 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: 03/18/2021

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: 12/10/2020
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 91210U223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 02/22/2021
• Supplement Dates FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1