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

Catalog Number CDS0601-NTR

Device Problems Leak/Splash (1354); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Patient Involvement (2645)

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The device was returned.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is being filed to report the leak in the cds.It was reported that during preparation of the clip delivery system (cds), a leak was noted at the lock lever port.The lock lever knob was loosened and retightened, as it appeared that the lock lever cap was not properly threaded.The cap was unable to be tightened therefore the device was not used and replaced with a new one.There was no clinically significant delay in the procedure and no patient involvement.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001.The reported issue of device misassembled during manufacturing / shipping and leak were confirmed via returned device analysis.A review of the lot history record revealed 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 other similar incidents reported from this lot.The leak appears to be a cascading effect of the cap offset on the lock lever.The cap offset on the lock lever (device misassembled during manufacturing / shipping) appears to be related to a product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular (av) will continue to trend the performance of these devices.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9278942
• MDR Text Key: 175226987
• Report Number: 2024168-2019-13207
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: 08717648226342
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2020
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 90812U275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 11/25/2019
• Supplement Dates FDA Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1