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

Model Number 12773-03

Device Problem Device Slipped (1584)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/13/2023

Event Type  malfunction  

Event Description

While inserting an abbott medical closure device, called perclose prostyle the device pulled through the iliac artery, removing a piece of calcium.This resulted in making a tear in the artery.

• Brand Name: PERCLOSE PROSTYLE
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591
• MDR Report Key: 16589846
• MDR Text Key: 311750594
• Report Number: 16589846
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 08717648235184
• UDI-Public: 08717648235184
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• 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: 3010741
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27375 DA
• Patient Sex: Male
• Patient Race: White