BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    MDR report key: 8169656 · Received December 17, 2018

    Report

    Report Number
    1820334-2018-03804
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    May 22, 2015
    Report Date
    December 17, 2018
    Manufacturer
    COOK INC
    Product Code
    PNO
    UDI-DI
    10827002352527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 A PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) IN A VERY CALCIFIED SFA (SUPERFICIAL FEMORAL ARTERY). IT WAS NOTED THAT THERE WAS "VERY POINTED" PLAQUE IN THE MIDDLE OF THE SFA. THE PHYSICIAN STARTED DIRECTLY WITH THE ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER. THE BALLOON WAS INFLATED VERY SLOWLY "ATM BY ATM." THE ENFORCER BALLOON BURST AT 6 ATM. THE STENOSIS WAS NOT OPEN, SO THE PHYSICIAN DILATED ANOTHER ENFORCER BALLOON OF THE SAME SIZE VERY SLOWLY AGAIN. HOWEVER, THE SECOND BALLOON BURST AT 16 ATM. AFTER THE ANGIOGRAM, STENOSIS WAS OPEN, SO THERE WERE NO FURTHER ACTIONS. BOTH OF THE COMPLAINT DEVICES WERE NOTED TO BE FROM THE SAME LOT, AND THE PRODUCT PROBLEMS DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010324 ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER PNO COOK INC NA 5388440 10827002352527

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR