BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX P3 PTA DILATATION CATHETER

    MDR report key: 2170257 · Received July 20, 2011

    Report

    Report Number
    9616099-2011-00490
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 19, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K032737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT AFTER UNEVENTFUL DILATION OF A VERY TORTUOUS LESION IN THE SUBCLAVIAN VEIN THE PTA CATHETER WAS HARD TO REMOVE FROM THE WIRE. AFTER REMOVAL THE CATHETER WAS NOTED TO BE KINKED. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE DEVICE THROUGH THE GUIDE CATHETER. ONE NON STERILE CATHETER POWERFLEX P3 8.0 MM X 4.0 CM 110 CM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE BALLOON APPEARS AS IF IT HAD BEEN INFLATED AND DEFLATED. CONTRAST MEDIUM RESIDUES WERE NOTED IN THE BALLOON. THREE KINKS WERE NOTED APPROXIMATED AT 26.0 MM, 33.0 MM AND 45.0 MM OF THE DISTAL TIP. NO OTHER ANOMALIES WERE OBSERVED IN THE RETURNED DEVICE. THE INSERTION /WITHDRAWAL TEST ACCORDING TO (B)(4) COULD BE PERFORMED HOWEVER RESISTANCE AND FRICTION WAS OBSERVED IN THE INNER BODY SECTION BALLOON DUE TO THREE KINKS. REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE BALLOON WITHDRAWAL DIFFICULTY AND PTA SYSTEM KINKED BENT- IN PATIENT FAILURE REPORTED BY THE CUSTOMER WERE CONFIRMED; HOWEVER, THE EXACT CAUSE OF BALLOON WITHDRAWAL DIFFICULTY AND PTA SYSTEM KINKED BENT- IN PATIENT COULD NOT BE CONCLUSIVELY DETERMINED, CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE UNITS FROM LEAVING THE FACILITY. NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE FAILURE EXPERIENCED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. REFER THE FOLLOWING (B)(4). THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THE PRODUCT IS AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT WAS A (B)(6) MALE. THE TARGET LESION WAS LOCATED IN THE SUBCLAVIAN VEIN. THE LESION WAS VERY TORTUOUS. INFLATION OF THE BALLOON WAS GOOD, BUT AFTER DEFLATION, THE CATHETER WAS HARD TO TAKE OFF THE WIRE. THE BALLOON WAS KINKED, SO THE PHYSICIAN USED ANOTHER P3 BALLOON (SAME SIZE). THIS BALLOON CATHETER DID NOT HAVE ANY PROBLEMS. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE DEVICE THROUGH THE GUIDE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERFLEX P3 PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA 15350841

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR