MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP XTR DELIVERY SYSTEM; MITRACLIP DELIVERY SYSTEM

Catalog Number CDS0602-XTR

Device Problems Break (1069); Unstable (1667)

Patient Problem No Patient Involvement (2645)

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report the loose cap.It was reported that during preparation of the clip delivery system (cds), while de-airing the device, the lock line cap was noted to be loose.The thread of the lock line was broken and stuck in the lock lever cap.The device was not used and replaced with a new cds.There was no clinically significant delay in the procedure and no patient involvement.No additional information was provided.

Manufacturer Narrative

Evaluation summary: all available information was investigated and the reported broken lock lever was confirmed via returned device analysis.The reported unstable cap could not be replicated in a testing environment.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Available information was investigated and the reported unstable cap appears to be related to the broken lock lever.The investigation did not identify an issue with design, manufacturing or labeling with the broken lever, but manufacturing could not be ruled out.The issue is being addressed per internal operating procedures.Abbott vascular (av) will continue to trend the performance of these devices.

• Brand Name: MITRACLIP XTR DELIVERY SYSTEM
• Type of Device: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8394362
• MDR Text Key: 137947856
• Report Number: 2024168-2019-01713
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2019
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 80824U113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1