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

Catalog Number CDS0602-XTR

Device Problems Break (1069); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Patient Involvement (2645)

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed for gripper line break.It was reported that during unpacking of a mitraclip xtr device, it was observed that the packaging plastic for the gripper lever was not present.It was decided to not use the device in a procedure.The device was functionality tested outside the patient anatomy.The gripper lever cap was turned one half and resistance was met.As the gripper line was slightly pulled, it immediately ruptured.The device was not used.There was no patient involvement and no clinically significant delay to the intended procedure.No additional information was provided regarding this device issue.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.All available information was investigated, and the gripper line break and disassemble device issues were not confirmed during returned device analysis.A review of the lot history record revealed no manufacturing nonconformities to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from the reported lot.All available information was investigated and a definitive cause for the reported gripper line break and device disassembled during manufacturing/shipping could not be determined in this complaint.It is possible that user technique/procedural circumstances and interpretation of the device packaging could have resulted in the reported issue; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9335494
• MDR Text Key: 177662307
• Report Number: 2024168-2019-13673
• 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: 12/17/2019

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: 07/26/2020
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 90726U108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 11/18/2019
• Supplement Dates Manufacturer Received: 11/25/2019
• Supplement Dates FDA Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1