MAUDE Adverse Event Report: ABBOTT MEDICAL ABBOTT PERCLOSE PROSTYLE

Model Number 12773-03

Device Problems Fracture (1260); Failure to Advance (2524); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981); No Flow (2991)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/03/2023

Event Type  Injury  

Event Description

Perclose device was used at case completion.The device was advanced at a 45 degree angle.Moderate resistance was noted while advancing the perclose.Pulsatile flow was not noted on the side port with advancement of the device and therefore, the device could not be pulled back or advanced at that point.Fluoro showed the transition point of the perclose device to be bent.The wire access hub was not visible in order to place a wire into the perclose for removal.Vascular surgery was consulted stat and md arrived to the cath lab and assessed the situation.Md recommended aggressive retraction force on the perclose device.When this was performed, the device fractured and the proximal portion of the device came out.But the distal portion of the perclose remained behind in the right common femoral artery.Pt went to a operating room.Refer to add'l documents in i2k.

• Brand Name: ABBOTT PERCLOSE PROSTYLE
• Type of Device: ABBOTT PERCLOSE PROSTYLE
• Manufacturer (Section D): ABBOTT MEDICAL; santa clara CA
• MDR Report Key: 17305531
• MDR Text Key: 318926352
• Report Number: 17305531
• 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: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12773-03
• Device Catalogue Number: 12773-03
• Device Lot Number: 3042641
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/03/2023
• Device Age: 3 MO
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White