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

Catalog Number CDS0602-XTR

Device Problems Leak/Splash (1354); Unstable (1667)

Patient Problem No Patient Involvement (2645)

Event Date 03/15/2019

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 being filed to report an unstable cap resulting in a clip delivery system (cds) leak.It was reported that during preparation of the clip delivery system (cds), the saline leaked out of the gripper cap.The cap was unable to close completely therefore the device was not used in the anatomy and there was no patient involvement.There was no clinically significant delay to the intended procedure.No additional information was provided regarding this device issue.

Manufacturer Narrative

Internal file number: (b)(4).Evaluation summary: the device was investigated and returned device analysis indicated that the reported delivery catheter (dc) handle leak and unstable gripper lever cap were confirmed during testing due to the observed missing polyimide tubing on the gripper line.A review of the lot history record identified no exception issued to the reported lot.Additionally, a review of the complaint history identified no other similar incidents from this lot.All available information was investigated and the reported dc handle leak and unstable cap appears to be due to the observed missing polyimide tubing on the gripper line; therefore, a potential product quality issue has been identified.The issue is being addressed per internal operating procedures.Abbott vascular 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: 8479150
• MDR Text Key: 140794206
• Report Number: 2024168-2019-02592
• 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: 06/10/2019

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: 01/11/2020
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 90110U186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Date Manufacturer Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1