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

Catalog Number CDS0503

Device Problems Break (1069); Unstable (1667); Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Date 12/20/2018

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 loose crimper and broken collet found during return device analysis.It was reported that during device preparation, the clip closed during the first attempt, but during the second attempt the clip would not close completely; therefore, the device was not used.There was no patient involvement and no clinically significant delay in the procedure.A new mitraclip was used successfully to complete the procedure.Return device analysis identified the released crimper was returned loose from the crimping cam and the 4 tines of the collet were broken.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).Evaluation summary: the device was returned.The reported inability opening the clip was confirmed during returned device analysis.The collet tines were observed to be broken, resulting in an observed loose release crimper and the reported inability opening the clip.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.The complaint assessment stated that as per initial review listed in the related records review section, there is indication that this complaint is related to actions with manufacturing as a root cause, however, the investigation is still on going.The issue is being addressed per internal operating procedures.Av will continue to trend the performance of these devices.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Type of Device: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8481062
• MDR Text Key: 140897773
• Report Number: 2024168-2019-02629
• 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: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2019
• Device Catalogue Number: CDS0503
• Device Lot Number: 80326U180
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/21/2019
• Date Manufacturer Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1