MAUDE Adverse Event Report: ABBOTT VASCULAR ABBOTT ANGIOSEAL; DEVICE, HEMOSTASIS, VASCULAR

Model Number 610130

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/12/2020

Event Type  Injury  

Event Description

Pt had cath lab procedure with angioseal deployment.Post procedure, she experienced a-fib requiring cardioversion, the lost pulses in her r foot.Vascular surgeon took to operating room and reported that the angioseal device was dissected free from the common femoral artery.They had to pass a 3 fogarty catheter down the superficial femoral artery and retrieve the end plate for the angioseal device in the posterior tibial artery.Fda safety report id# (b)(4).

• Brand Name: ABBOTT ANGIOSEAL
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 10613402
• MDR Text Key: 209610528
• Report Number: MW5096997
• Device Sequence Number: 1
• Product Code: MGB
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 610130
• Device Catalogue Number: 610130
• Device Lot Number: 06102070
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2020
• 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): Other; Required Intervention
• Patient Age: 81 YR