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

Model Number CDS0601-XTR

Device Problems Leak/Splash (1354); Unstable (1667); Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.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 preparation of the clip delivery system (cds), while bleeding the lock lever cap, the physician turned it all the way off.When attempting to put the cap back on, it was noted the cap was unable to be fully shut.Bubbles were then observed inside the cds; therefore, the device was not used and was replaced.There was no clinically significant delay in the procedure.No additional information provided.

Manufacturer Narrative

The device was not returned for 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 incidents reported from this lot.It should be noted that the mitraclip instructions for use states ¿loosen the lock lever and the gripper lever caps to de-air.Do not turn the lever caps more than ½ turn in the ¿open¿ direction.After de-airing, tighten the lever caps¿.In this complaint it was reported that the user fully twisted-off the lock lever cap when de-airing.Based on the available information, the reported leak appears to have been a result of improper or incorrect procedure or method.The improper or incorrect procedure or method use was due to the user fully unscrewing the lock lever cap.The unstable cap was likely a cascading effect of the improper or incorrect procedure and not retightening the cap all the way.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• Brand Name: MITRACLIP XTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11687938
• MDR Text Key: 248513295
• Report Number: 2024168-2021-03256
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: 08717648226366
• 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: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2021
• Device Model Number: CDS0601-XTR
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 00909U141
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1