MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP XT; HEART VALVE REPAIR DEVICE

Model Number CSD0601-XTR

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/12/2018

Event Type  Injury  

Event Description

Malfunction of gripper line in mitra clip device prevented clip release after clasp was made.Device had to be retracted and entire new system/device used and deployed.

• Brand Name: MITRACLIP XT
• Type of Device: HEART VALVE REPAIR DEVICE
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 8079586
• MDR Text Key: 128032149
• Report Number: MW5081402
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSD0601-XTR
• Device Lot Number: 80828U290
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR