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

Model Number CDS0701-XTW

Device Problems Difficult to Insert (1316); Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is being filed to report the torn clip introducer.It was reported that during preparation of the clip delivery system (cds), when inserting the clip into the clip introducer (ci), one clip arm went outside the ci.The clip was pulled back and it was noted the ci was torn.There was no patient involvement and the cds was not used in a procedure.There was no clinically significant delay to the intended procedure.No additional information was provided regarding this device issue.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on all available information, the reported difficult to insert appears to be related to user technique.The reported torn clip introducer was a cascading effect of the reported difficult to insert.There is no indication of a product issue with respect to manufacture, design or labeling.

• 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: 11133881
• MDR Text Key: 225807539
• Report Number: 2024168-2021-00230
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

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: 07/17/2021
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 00717U176
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 02/12/2021
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1