MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD); MITRAL VALVE REPAIR DEVICES

Catalog Number CDS0702-XTW

Device Problem Material Separation (1562)

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

Event Date 02/29/2024

Event Type  malfunction  

Event Description

It was reported that during device preparation, the clip delivery system (cds) opened from its packaging (first clip to be used in the case).No damage was evident on the packaging.Upon opening the packaging, a screw was loose in the plastic packaging.The screw was loose from the dc handle, the second from the left under the gripper lever.No preparation steps took place prior to this.The cds was therefore immediately deemed faulty and was not used.A new cds was immediately opened and prepared.There was no significant time delay and the rest of the case was completed without issue.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

All available information was investigated, and the reported loose dc handle screw 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 complaints reported from this lot.Based on available information and the returned device analysis, the investigation determined the loose dc handle screw to be related to a potential product quality issue.This complaint is within the scope of an exception escalation as the complaint description and device code match the specific issue described in the exception.Therefore, this incident was added to exception (issue) 130612 for further investigation.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18952634
• MDR Text Key: 338432198
• Report Number: 2135147-2024-01300
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231018
• UDI-Public: (01)08717648231018(17)241029(10)31031R1030
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

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 Catalogue Number: CDS0702-XTW
• Device Lot Number: 31031R1030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1