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

Model Number PERCLOSE PROGLIDE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Medtronic received information that following the implant of a transcatheter bioprosthetic valve, when closing the incision after removing the delivery catheter system (dcs), a perclose proglide closure system did not fit properly into the left femoral artery and the intima of the blood vessel was torn.Hemostasis was performed using two stent grafts.No adverse patient effects were reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERCLOSE
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 17537642
• MDR Text Key: 321046622
• Report Number: MW5144492
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: PERCLOSE PROGLIDE
• Patient Sequence Number: 1