MAUDE Adverse Event Report: ABBOTT LABORATORIES / ABBOTT VASCULAR ABBOTT PERCLOSE PROSTYLE SUTURE MEDIATED CLOSURE/REPAIR; DEVICE, HEMOSTASIS, VASCULAR

Catalog Number 1277303

Device Problems Fracture (1260); Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 01/19/2023

Event Type  malfunction  

Event Description

Patient undergoing tavr (transcatheter aortic valve replacement).During site access to right femoral artery, the abbott perclose device malfunctioned requiring open vascular retrieval and femoral artery repair.The posterior foot plate was fractured and could not be located.

• Brand Name: ABBOTT PERCLOSE PROSTYLE SUTURE MEDIATED CLOSURE/REPAIR
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): ABBOTT LABORATORIES / ABBOTT VASCULAR
• MDR Report Key: 16446835
• MDR Text Key: 310367202
• Report Number: MW5115244
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1277303
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White