MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP DELIVERY SYSTEM; VALVE REPAIR

Model Number CDS0601-NTR

Device Problems Unstable (1667); Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Date 04/06/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history did not identify any similar incidents reported from this lot.The investigation determined the reported out of socket arm positioner result in mechanical jam appears to be related to a potential product issue.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.

Event Description

This is filed to report the unstable arm positioner.It was reported that during preparation, the back end of the arm positioner looked to be out of socket and was unable to rotate.Therefore, the clip delivery system (cds) was not used and was replaced.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: MITRACLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10005441
• MDR Text Key: 189224941
• Report Number: 2024168-2020-03946
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: 08717648226342
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2020
• Device Model Number: CDS0601-NTR
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 91203U148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1