BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    MDR report key: 8169581 · Received December 17, 2018

    Report

    Report Number
    1820334-2018-03803
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    May 20, 2015
    Report Date
    December 17, 2018
    Manufacturer
    COOK INC
    Product Code
    PNO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER WAS PLACED IN A CALCIFIED LESION AND DILATED UP TO NOMINAL PRESSURE OF 10 ATM (ATMOSPHERES). THE PROCEDURE WAS TO PERFORM ANTEGRADE PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) IN THE SFA (SUPERFICIAL FEMORAL ARTERY) ON THE LEFT SIDE. THE BALLOON DID NOT FULLY OPEN WHEN IT WAS INFLATED TO 10 ATM, SO THE PHYSICIAN DECIDED TO INCREASE THE PRESSURE TO HE RBP (RATED BURST PRESSURE) OF 16 ATM. HOWEVER, THE BALLOON BURST AT 13 ATM. AS A RESULT, ANOTHER MANUFACTURER'S BALLOON WAS INFLATED UP TO 26 ATM WITHOUT BURSTING. THE PROCEDURE WAS COMPLETED WITH THE PLACEMENT OF ANOTHER MANUFACTURER'S STENT IN THIS PART, AND A ZILVER PTX IN THE PROXIMAL SFA. THE PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008186 ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER PNO COOK INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1