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

Catalog Number CDS0602-NTR

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

Patient Problem No Patient Involvement (2645)

Event Date 12/30/2020

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 is being filed to report the clip jumping during device preparation.It was reported that during preparation of the clip delivery system (cds), after establishing final arm angle (efaa), the clip was unlocked and opened.Resistance was felt turning the arm positioner and the clip jumped open to 180 degrees.The cds was not used in a procedure and there was no patient involvement.There was no clinically significant delay to the intended procedure and no patient involvement.No additional information was provided regarding this device issue.

Manufacturer Narrative

All available information was investigated, and the reported clip jumpiness and resistance on the arm positioner (physical resistance/sticking) was not 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 from the lot.All available information was investigated and based on information provided and the results of the returned device analysis, a cause for the reported physical resistance/sticking of the arm positioner and clip jumpiness (clip jumped open) could not be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.

• 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: 11156275
• MDR Text Key: 226312196
• Report Number: 2024168-2021-00346
• 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: 02/18/2021

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: 08/26/2021
• Device Catalogue Number: CDS0602-NTR
• Device Lot Number: 00826U189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 01/12/2021
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1