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

Model Number CDS0701-XT

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 06/16/2022

Event Type  malfunction  

Event Description

During mitraclip procedure the clip malfunctioned causing the procedure to be aborted.

• Brand Name: MITRACLIP
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd; temecula CA 92591
• MDR Report Key: 15084111
• MDR Text Key: 296386197
• Report Number: 15084111
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230981
• UDI-Public: (01)08717648230981
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/01/2022

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-XT
• Device Catalogue Number: CDS0701-XT
• Device Lot Number: 20307R125
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Sex: Male