BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PTA BALLOON DILATATION CATHETER

    MDR report key: 1120605 · Received August 13, 2008

    Report

    Report Number
    2020394-2008-00220
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Report Date
    July 22, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K052236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS MANUFACTURING LOT NUMBER. THE SAMPLE WAS DISCARDED AT THE USER FACILITY AND NOT RETURNED. THE RESULT OF THE INVESTIGATION IS INCONCLUSIVE AND THE ROOT CAUSE OF THE EVENT IS UNKNOWN. THE CURRENT IFU (INFO FOR USE) FOR THIS PRODUCT STATES THE FOLLOWING: WARNING: IF RESISTANCE IS FELT DURING POST PROCEDURE WITHDRAWAL OF THE CATHETER, IT IS RECOMMENDED TO REMOVE THE BALLOON CATHETER AND GUIDEWIRE/INTRODUCER SHEATH AS A SINGLE UNIT. APPLYING EXCESSIVE FORCE TO THE CATHETER CAN RESULT IN TIP BREAKAGE OR BALLOON SEPARATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON HAD TO BE REMOVED WITH THE SHEATH AS ONE UNIT. THERE WERE THREE PTA BALLOON USED ON THE PATIENT AND THERE WERE TWO INFLATIONS, USING AN INFLATION DEVICE ON EACH. THE FIRST INFLATION WAS HELD AT 8-10 ATM FOR ABOUT 2 MINUTES AND THE SECOND ONE AT 8-10 ATM FOR 1 MINUTE. A 7 F SHEATH AND 0.035 WIRE WERE USED FOR THE PROCEDURE. THE TRACKING ANATOMY WAS NOT TORTUOUS OR CALCIFIED AND THERE WERE NO STENTS. IT WAS AFTER COMPLETING THE ANGIOPLASTY OF THE SUBCLAVIAN VEIN, THAT THE BALLOON AND THE SHEATH HAD TO BE REMOVED TOGETHER. THE PHYSICIAN USED THE INFLATION DEVICE AND A 30CC SYRINGE TO DEFLATE THE BALLOON, BUT IT WOULD NOT RETRACT THROUGH THE SHEATH. THERE WAS NO REPORTED INJURY TO THE PATIENT AND NO ADDITIONAL INTERVENTIONS REQUIRED. IT WAS ALLEGED THAT IT MAY BE THE SHEATH TAPERS AT THE END WHICH MAY BE CONTRIBUTING TO THE BALLOON GETTING STUCK. ON THE THIRD AND FINAL BALLOON, WHERE THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT, THE PHYSICIAN CHANGED TO AN 8F SHEATH AND HAD BETTER RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. GFSE1761

    Patients

    Seq Age Sex Outcome Treatment
    1