BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXER CHECK-FLO INTRODUCER ANSEL MODIFICATION

    MDR report key: 11966083 · Received May 25, 2021

    Report

    Report Number
    11966083
    Event Type
    Injury
    Date Received
    May 25, 2021
    Date of Event
    April 26, 2021
    Report Date
    May 3, 2021
    Manufacturer
    COOK INCORPORATED
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A LEFT LOWER EXTREMITY ANGIOGRAM AND INTERVENTION PROCEDURE WAS PERFORMED FOR WORSENING CLAUDICATION AND REST PAIN. AN UNEXPLAINED THROMBUS DEVELOPED AFTER ATHERECTOMY/ ANGIOPLASTY OF THE SUPERFICIAL FEMORAL ARTERY WHICH WAS LYSED. THE PATIENT WAS DISCHARGED FROM OUR CENTER WITHOUT ISSUES. HOWEVER, SEVERAL HOURS LATER HE CONTACTED DR. (B)(6) REGARDING PAIN IN HIS FOOT WITH DECREASED TEMPERATURE. HE WAS INSTRUCTED TO REPORT TO THE CLOSEST HOSPITAL (B)(6) WHERE DR. (B)(6) PERFORMED AN ANGIOGRAM OF HIS LEFT LEG SHOWING THROMBOSIS OF HIS POPLITEAL AND TIBIAL VASCULATURE. EVENTUALLY, A SMALL PIECE OF PLASTIC WAS RETRIEVED FROM THE POSTERIOR TIBIAL ARTERY, WHICH REPRESENTED THE INSIDE LINING OF A COOK GUIDING SHEATH (45 CM). DESPITE MULTIPLE FOLLOW-UP ANGIOGRAMS AND LYSIS PROCEDURES OVER THE NEXT 24 HOURS, REVASCULARIZATION OF HIS FOOT WAS NOT POSSIBLE, REQUIRING AN AMPUTATION. OUR CENTER IVC REPORTED THIS EVENT TO COOK MEDICAL AND ALSO TO CARDIOVASCULAR SYSTEMS, INC. (THE MAKER OF THE ATHERECTOMY DEVICE DIAMONDBACK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778113 FLEXER CHECK-FLO INTRODUCER ANSEL MODIFICATION 6FR X45 CM COOK ANSEL SHEATH DYB COOK INCORPORATED KCFW-6.0-18/38-45-RB 13763460

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R| S