BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCULAR LOOP

    MDR report key: 5728085 · Received June 15, 2016

    Report

    Report Number
    1645362-2016-00004
    Event Type
    Injury
    Date Received
    June 15, 2016
    Date of Event
    May 9, 2016
    Report Date
    June 15, 2016
    Manufacturer
    INTERNATIONAL BIOPHYSICS CORPORATION
    Product Code
    DWS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON MAY 23, 2016 THE ORIGINAL COMPLAINT WAS CLOSED AFTER INVESTIGATION. THE COMPLAINT WAS RE-OPENED WHEN ADDITIONAL INFORMATION WAS RECEIVED BY THE CUSTOMER ON 06/09/2016. THE DEVICE WAS RETURNED FOR EVALUATION, AND BASED ON THE RESULTS OF THE TESTING PERFORMED ALL PRODUCTS OPERATED WITHIN SPECIFICATION AND THERE WERE NO DEFECTS NOTED. NO ROOT CAUSE COULD BE ESTABLISHED.

    Description of Event or Problem · 1

    REPORTED BY CUSTOMER: "SALES REP REPORTED VIA EMAIL THE PRODUCT IS STRETCHING LIKE RUBBER BANDS. ON 31MAY2016 ADDITIONAL INFORMATION: WAS THE PRODUCT RECEIVED IN THIS CONDITION? YES. IF NOT, WHAT WAS THE PRODUCT BEING USED FOR WHEN IT WAS OBSERVED THAT PRODUCT IS STRETCHING LIKE RUBBER BANDS? THESE ARE USED ON CAROTIDS AND ENDOVASCULAR STENT CASES. PLEASE CONFIRM WHETHER OR NOT THERE WAS ANY PATIENT IMPACT. YES, NUMEROUS DOCTORS HAD TROUBLE CONTROLLING THE BLEEDING AND HAD TO USE CLAMPS INSTEAD. DO YOU HAVE THE LOT#? WERE SENT IN BUT ALL PRODUCT ON OUR SHELVES ARE NOT SAFE FOR USE. THE NEW LIGA-LOOPS APPEAR TO BE MADE FROM PLASTIC MATERIAL WITH MINIMAL ELASTICITY. THE PLASTIC JUST STRETCHES AND DOES NOT CONSTRICT TO CONTROL THE BLEEDING. BOTH CASES THE SURGEONS HAD BLOOD BATHS DURING THE PROCEDURES WHICH ULTIMATELY AFFECT THE PATIENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381921 VASCULAR LOOP INSTRUMENTS, SURGICAL, CARDIOVASCULAR DWS INTERNATIONAL BIOPHYSICS CORPORATION CH114 030116-4163

    Patients

    Seq Age Sex Outcome Treatment
    1 Other