MAUDE Adverse Event Report: ABBOTT LABORATORIES ABBOTT PERCLOSE CLOSURE DEVICE; DEVICE, HEMOSTASIS, VASCULAR

Model Number 12673-03

Device Problem Sticking (1597)

Patient Problem Tissue Damage (2104)

Event Date 02/27/2018

Event Type  Injury  

Event Description

While performing a tavr procedure in the hybrid or the perclose closure device became stuck in the left femoral artery.This resulted in the need for the or (operating room) team to perform a surgical cut down to repair artery.The patient was discharged home 3 days after without further incident.

• Brand Name: ABBOTT PERCLOSE CLOSURE DEVICE
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): ABBOTT LABORATORIES; chicago IL
• MDR Report Key: 7464562
• MDR Text Key: 106797818
• Report Number: MW5076789
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 12673-03
• Device Catalogue Number: 12673-03
• Device Lot Number: 8011741
• Other Device ID Number: 28717648013083
• 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: 87 YR