BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER

    MDR report key: 3181122 · Received June 20, 2013

    Report

    Report Number
    9616099-2013-00385
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING. HOWEVER, THE PRODUCT HAS NOT BEEN RETURNED AS OF TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    AS REPORTED, A POWERFLEX PRO BALLOON CATHETER RUPTURED AT SEVEN ATMOSPHERES DURING POST-DILATION OF AN UNKNOWN SELF-EXPANDING STENT WITHIN THE AORTA. THE LESION WAS REPORTED AS FOCAL AND CALCIFIED. THE STENT WAS DEPLOYED IN THE DISTAL AORTA APPROXIMATELY TWO TO THREE CENTIMETERS ABOVE THE ILIAC BIFURCATION. ANOTHER BALLOON CATHETER HAD ALSO RUPTURED PRIOR TO USING THE POWERFLEX PRO. THERE WAS NO REPORTED PATIENT INJURY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER BALLOON CATHETER. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. WITHOUT RETURN OF THE DEVICE THE REPORTED ¿BALLOON BURST AT/BELOW RBP¿ COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE ARE VESSEL CHARACTERISTICS (FOCAL AND CALCIFIED) AND PROCEDURAL FACTORS (POST-DILATION OF A STENT) THAT MAY HAVE CONTRIBUTED TO THE REPORTED BURST. NEITHER THE INFORMATION AVAILABLE NOR THE DHR SUGGESTS THAT THE BURST COULD BE RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT THE 80 CM. POWERFLEX PRO 10 MM. X 2 CM. BALLOON CATHETER RUPTURED AT SEVEN (7) ATMOSPHERES (ATM.). ANOTHER BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE POWERFLEX PRO WAS BEING USED TO POST-DILATE AN UNKNOWN SELF-EXPANDING STENT IN AN AORTA INTERVENTIONAL PROCEDURE. THE STENT WAS DEPLOYED IN THE DISTAL AORTA APPROXIMATELY 2 TO 3 CENTIMETERS ABOVE THE ILIAC BIFURCATION. ANOTHER BALLOON CATHETER HAD ALSO RUPTURED PRIOR TO USING THE POWERFLEX PRO. THE LESION WAS REPORTED TO BE FOCAL AND CALCIFIED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280242 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER PTA CATHETERS LIT CORDIS DE MEXICO NA 15679444

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR BC: ABBOTT FOXCROSS, BARD DURADO BALLOON