BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    MDR report key: 8169684 · Received December 17, 2018

    Report

    Report Number
    1820334-2018-03801
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    March 26, 2015
    Report Date
    December 17, 2018
    Manufacturer
    COOK INC
    Product Code
    PNO
    UDI-DI
    10827002352619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON NAME: PNO CATHETER, PERCUTANEOUS, CUTTING/SCORING. PRODUCT CODE: PNO. THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL (B)(4), COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT THE DOCTOR HAD USED ANOTHER MANUFACTURER'S DEVICE AND PERFORMED THROMBOLYSIS. THERE WAS PERSISTENT INTRASTENT THROMBUS, SO THE DOCTOR NEEDED TO BALLOON THROUGH THAT. THE BALLOON ON THE ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER RUPTURED WHILE BALLOONING A SERIES OF STENTS. IT DID "WELL" AT BALLOONING THE TOP AND MIDDLE STENTS, BUT RUPTURED ON THE INFERIOR ASPECT OF THE WALL STENT. THE ENFORCER BURST LONGITUDINALLY AT A RATE OF APPROXIMATELY 6ATM (ATMOSPHERES). ANOTHER MANUFACTURER'S BALLOON WAS USED TO BALLOON THE DISTAL STENT, AND IT DID NOT RUPTURE. THIS PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010578 ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER PNO COOK INC NA 5271219 10827002352619

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR