BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT VASCULAR PERCLOSE

    MDR report key: 13967417 · Received March 30, 2022

    Report

    Report Number
    MW5108661
    Event Type
    Injury
    Date Received
    March 30, 2022
    Date of Event
    October 28, 2021
    Report Date
    March 28, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    08717648013089
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RETAINED PRE-CLOSE DEVICE IN RIGHT CFA REQUIRING SURGICAL REMOVAL AND REPAIR. THE RIGHT FEMORAL ARTERY WAS ACCESSED, AND A 7-FRENCH SHEATH WAS INTRODUCED IN THE FEMORAL ARTERY. WE THEN USED THE "PRECLOSE" TECHNIQUE AND POSITIONED AN UNDEPLOYED PERCLOSE SUTURES IN THAT COMMON FEMORAL ARTERY AT THE 10 O'CLOCK POSITION, HOWEVER THAT DEVICE COULD NOT BE REMOVED. WE TRIED MULTIPLE MANEUVERS INCLUDING BALLOONING AROUND THE PERCLOSE NEEDLE, BUT THE PERCLOSE DEVICE WOULD NOT BUDGE. WE CALLED FOR VASCULAR SURGERY TO REMOVE THE DEVICE WITH A CUTDOWN APPROACH. THE PERCLOSE DEVICE METAL PORTION WAS IDENTIFIED TO BE LOOSE AND STUCK WITHIN THE SCAR TISSUE WHICH WAS THEN REMOVED. THE PLASTIC PORTION OF THE PERCLOSE DEVICE WAS STILL INTRALUMINAL. THE FOGARTY CATHETER WAS THEN USED TO HOLD THE PLASTIC PIECE WITH THE BALLOON AND GENTLE TRACTION BACK TOWARDS THE ARTERIOTOMY REVEALED THE PLASTIC PORTION WAS REMOVED IN ITS ENTIRETY. PULSATILE FLOW WAS PRESENT. BOVINE PERICARDIAL WAS BROUGHT ONTO THE SURGICAL FIELD. THE PATCH WAS THEN FASHIONED TO THE ARTERIOTOMY. A 6-0 PROLENE SUTURE WAS USED TO START AT BOTH APICES AND MEETING IN THE MIDDLE ON EACH SIDE CLOSING THE ARTERIOTOMY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872869 ABBOTT VASCULAR PERCLOSE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR 1081942 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention