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

Catalog Number CDS0601-NTR

Device Problems Crack (1135); Product Quality Problem (1506); Unstable (1667)

Patient Problem No Patient Involvement (2645)

Event Date 03/06/2019

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 was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report the unstable lock lever cap.It was reported that during device preparation, the lock lever did not appear threaded and appeared cracked.Subsequently, the lock lever cap was unable to thread onto the device.The device was not used.There was no patient involvement.There was no additional information provided.

Manufacturer Narrative

Internal file number: (b)(4).Evaluation summary: all available information was investigated, and the reported broken/cracked lock lever was confirmed via returned device analysis.The reported irregular appearance was not confirmed.The 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 did not indicate a lot-specific quality issue.Available information was investigated, and a conclusive cause for the irregular appearance cannot be determined.The reported unstable cap appears to be related to the broken lock lever.Investigation determined the broken lever may 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.

• 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: 8462746
• MDR Text Key: 140315608
• Report Number: 2024168-2019-02416
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2019
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 80802U204
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/21/2019
• Date Manufacturer Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1