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

Catalog Number CDS0705-NT

Device Problems Leak/Splash (1354); Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This will be filed to report lock lever leak.It was reported that during preparation of the clip delivery system (cds) when flushing started, the physician noted a leak from between the lock lever and lock lever cap.The physician tried to re-cap the lock lever, but resistance was felt when tightening; therefore, the cds was changed to a new one.The procedure was completed with no issue.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported leak and resistance tightening the cap were confirmed via returned device analysis.It was observed that the polyimide tubing was protruding between the o-ring and the cap.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The investigation determined the reported leak and resistance tightening the cap appear to be related to the identified polyimide tubing protrusion.The protrusion appears 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.

• 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: 11090760
• MDR Text Key: 224860371
• Report Number: 2024168-2020-10993
• 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: 03/04/2021

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: 08/14/2021
• Device Catalogue Number: CDS0705-NT
• Device Lot Number: 00815U116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 02/09/2021
• Supplement Dates FDA Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 54