BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHARGER¿

    MDR report key: 2962538 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00625
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K110122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: AN EXAMINATION OF THE WIRE FOUND THAT THE GUIDEWIRE WAS STRETCHED AND COILED AT ONE END. NO KINKS OR DAMAGE WERE NOTED WITH THE DEVICE. IT WAS NOT POSSIBLE TO PASS THE STRETCHED COILED SECTION OF THE GUIDEWIRE THROUGH THE WIRE LUMEN OF THE CHARGER DEVICE. HOWEVER, USING THE OTHER END OF THE GUIDEWIRE, IT WAS POSSIBLE TO PASS THIS END OF THE WIRE THROUGH THE TIP AND WIRE LUMEN WITH NO RESISTANCE NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF CAUSED BY OTHER DEVICE. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2013-00622. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY IN THE LOWER LEG THE BALLOON STUCK ON THE WIRE. A NON BSC GUIDE WIRE WAS PLACED DISTALLY INTO THE LEFT LEG OF THE PATIENT TO DILATE THE SUPERFICIAL FEMORAL ARTERY. THE FIRST BALLOON, CHARGER 6.0 X 120 MM, WAS INSERTED AD COULD NOT BE ADVANCED OVER THE GUIDE WIRE. THIS BALLOON WAS ABLE TO BE REMOVED. WITH THE SAME WIRE STILL IN PLACE A SECOND BALLOON, CHARGER 4.0 X 100 MM WAS INSERTED OVER THE WIRE AND BECAME STUCK ON THE WIRE. WHILE ATTEMPTING TO REMOVE THIS BALLOON THE BALLOON STARTED TO STRETCH SOME AND THE PHYSICIAN WAS CONCERNED THAT THE BALLOON WOULD HAVE TORN IF HE CONTINUED TO PULL ON IT, THEREFORE, HE REMOVED THE BALLOON AND THE WIRE TOGETHER AS ONE UNIT. A THIRD BALLOON, CHARGER 4 X 20 MM, WAS INSERTED OVER A NEW NON BSC GUIDE WIRE AND THIS BALLOON BECAME STUCK ON THE WIRE AS WELL. A NON BSC BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2013-00622. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY IN THE LOWER LEG THE BALLOON STUCK ON THE WIRE. A NON BSC GUIDE WIRE WAS PLACED DISTALLY INTO THE LEFT LEG OF THE PATIENT TO DILATE THE SUPERFICIAL FEMORAL ARTERY. THE FIRST BALLOON, CHARGER 6.0X120MM, WAS INSERTED AD COULD NOT BE ADVANCED OVER THE GUIDE WIRE. THIS BALLOON WAS ABLE TO BE REMOVED. WITH THE SAME WIRE STILL IN PLACE A SECOND BALLOON, CHARGER 4.0X100MM WAS INSERTED OVER THE WIRE AND BECAME STUCK ON THE WIRE. WHILE ATTEMPTING TO REMOVE THIS BALLOON THE BALLOON STARTED TO STRETCH SOME AND THE PHYSICIAN WAS CONCERNED THAT THE BALLOON WOULD HAVE TORN IF HE CONTINUED TO PULL ON IT, THEREFORE, HE REMOVED THE BALLOON AND THE WIRE TOGETHER AS ONE UNIT. A THIRD BALLOON, CHARGER 4X20MM, WAS INSERTED OVER A NEW NON BSC GUIDE WIRE AND THIS BALLOON BECAME STUCK ON THE WIRE AS WELL. A NON BSC BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65333 CHARGER¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939206040210 15618179

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: J WIRE, NAVILYST