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

Catalog Number CDS0705-XTW

Device Problems Difficult to Open or Close (2921); Noise, Audible (3273); Physical Resistance/Sticking (4012)

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

Event Date 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

All available information was investigated, and the reported physical resistance / sticking (arm positioner) and noise, audible (noise) were confirmed via returned device analysis.The reported difficult to open or close (clip open - difficult) could not be replicated in a testing environment.The clip was discovered to be twisted over the l-lock shaft.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 did not indicate a lot-specific quality issue.Based on available information, the reported difficult to open or close (clip open - difficult), physical resistance / sticking (arm positioner), and noise, audible (noise) were related to the twisting/ offsetting between components (clip and l-lock shaft) and crack (l-lock tabs).A cause of the observed material twisted / bent could not be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Na.

Event Description

It was reported that during preparation of the clip delivery system (cds), the arm positioner was met with resistance during functional testing.During attempt to open the clip (unlock the clip and attempt to open), the clip would not open easily.Several attempts were performed, but the clip would still not open smoothly.It was noted when turning the arm positioner, an audible noise can be heard.The device was not used.A replacement device was used to complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.

• 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: 18815487
• MDR Text Key: 336640165
• Report Number: 2135147-2024-00947
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Report Date: 03/01/2024

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: CDS0705-XTW
• Device Lot Number: 30802R1033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2023
• 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
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 60 KG