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

Catalog Number CDS0601-NTR

Device Problems Loose or Intermittent Connection (1371); Difficult to Open or Close (2921); Insufficient Information (3190)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: all available information was investigated.The returned device analysis confirmed the reported mechanical jam (clip close inability) and reported device operated differently.Furthermore, the investigation identified loose release crimper from the crimping cap.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 incident reported from this lot.Based on all information, the reported mechanical jam of inability to open the clip and device operate differently than expected appears to be related to the loose release crimper.The observed loose release crimper appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

Event Description

This is reported as returned device analysis noted the release crimper was loose.It was reported that during preparation of the clip delivery system (cds), the clip was unable to close.Troubleshooting attempts were done however without success.It was observed that the device felt different and there was resistance felt, however, it is unknown the type of resistance and at what point during prep it was felt.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.Subsequent returned device analysis noted the release crimper was loose.

Manufacturer Narrative

Device codes: 1371 not labeled.

• Brand Name: MITRACLIP NTR 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: 8710281
• MDR Text Key: 148406425
• Report Number: 2024168-2019-04840
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: 08717648226342
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2020
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 90304U115
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/21/2019
• Date Manufacturer Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1