BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 9009899 · Received September 12, 2019

    Report

    Report Number
    1820334-2019-02281
    Event Type
    Malfunction
    Date Received
    September 12, 2019
    Report Date
    September 12, 2019
    Manufacturer
    COOK INC
    Product Code
    LIT
    UDI-DI
    10827002503264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCCUPATION = NON-HEALTHCARE PROFESSIONAL. PMA/510(K) NUMBER = K170193. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED, PRIOR TO PATIENT CONTACT DURING AN UNKNOWN PROCEDURE, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER SEPARATED. THE PHYSICIAN REPORTED THAT THE WIRE WOULD NOT ADVANCE THROUGH THE DEVICE AND IT FELT AS THOUGH SOMETHING WAS STUCK. THE DEVICE REPORTEDLY SEPARATED "FULLY DOWN THE MIDDLE". ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT REPORTEDLY HAD (B)(6). THERE HAS BEEN NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY, THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES, OR THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803824 ADVANCE 14 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COOK INC G50326 9863097 10827002503264

    Patients

    Seq Age Sex Outcome Treatment
    1