MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number CDS0701-XTW

Device Problems Break (1069); Product Quality Problem (1506); Unstable (1667)

Patient Problem No Patient Involvement (2645)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation not yet been completed.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed for an unstable lock lever cap.It was reported that the clip delivery system (cds) was prepared for use per instructions for use (ifu) and no issues were noted.When bleeding the lock lever cap, it was noted that the cap appeared to be broken, as it looked tilted.The cap could not be removed and forceps were used to loosen the cap.After the cap was able to be loosened, it could not be tightened, as if the threads were stripped.The device was not used and there was no patient involvement.A second cds was used to complete the procedure.There was no adverse patient effect or clinically significant delay.No additional information was provided.

Manufacturer Narrative

The device was returned and investigated.The reported break on lock lever, irregular appearance and unstable cap was 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 this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The investigation determined the reported break- lock lever shaft, irregular appearance and unstable cap appear to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular (av) will continue to trend the performance of these devices.Na.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11074261
• MDR Text Key: 225806006
• Report Number: 2024168-2020-10943
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• 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: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2021
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 00717U104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1