MAUDE Adverse Event Report: ABBOTT VASCULAR INC. MITRACLIP; MITRAL VALVE REPAIR DEVICES

Model Number CDS0701-XTW

Device Problem Separation Problem (4043)

Patient Problem Insufficient Information (4580)

Event Date 01/11/2023

Event Type  malfunction  

Event Description

A mitraclip was being performed on this patient.When deploying the clip, the lock would not work.The clip placement had to be aborted and a new mitraclip had to be placed.

• Brand Name: MITRACLIP
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez rd; temecula CA 92591
• MDR Report Key: 16459035
• MDR Text Key: 310446243
• Report Number: 16459035
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 20907R1048
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29565 DA
• Patient Sex: Male