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

Catalog Number CDS0602-NTR

Device Problems Mechanical Problem (1384); Material Separation (1562); Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Exemption number (b)(4)-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 detachment of device component it was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.After the clip delivery system (cds) was inserted, it was noticed that the spring of the release pin slipped out a few millimeters.The spring was easily put back into the correct position; however, it was noted that the small ball at the end of the spring was missing.The ball was found on the sterile table and the procedure was continued.One clip was implanted reducing mr to a grade of <1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Device codes: 1667 labeled.Internal file number - (b)(4).Correction - removed code 1384 replaced with 1667.Evaluation summary: the returned device analysis was unbale to confirm the reported detachment of ball bearing as the ball was returned attached to the release pin.The reported for unstable (spring) during use could not be replicated in a testing environment as the spring was not returned.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The investigation determined the reported detachment of ball bearing, unstable spring and observed missing spring appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular (av) 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: 8772760
• MDR Text Key: 150456572
• Report Number: 2024168-2019-05466
• 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: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2020
• Device Catalogue Number: CDS0602-NTR
• Device Lot Number: 90215U103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Date Manufacturer Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER