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

Catalog Number CDS0602-NTR

Device Problems Leak/Splash (1354); Product Quality Problem (1506); Unstable (1667); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2021

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 is filed to report a leak.It was reported that during that during preparation of the clip delivery system (cds), the lock lever cap was not in a good position.Then during flushing, a leak was observed from the lever.The cds was not used in the patient.The procedure was successfully completed with a new cds.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The returned device analysis confirmed the reported inability to unthread the lock lever cap, and the product quality problem associated with the tilted cap resulting in a leak.The investigation determined that the twisted lock lever shaft, inability to unthread the lock lever cap and tilted lock lever cap resulting in the leak appears to be related to a potential product issue.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.A review of the complaint history identified no similar complaints from the lot.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.H6: device code 1667 was removed.

Event Description

Subsequent to the initially filed report, the following information was received: the lock lever cap was stuck.No additional information was provided.

• Brand Name: MITRACLIP NTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11542846
• MDR Text Key: 243196091
• Report Number: 2024168-2021-02211
• 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: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2021
• Device Catalogue Number: CDS0602-NTR
• Device Lot Number: 00827U131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1