BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX P3 PTA DILATATION CATHETER

    MDR report key: 1454774 · Received April 30, 2009

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    Report

    Report Number
    9610978-2009-00096
    Event Type
    Malfunction
    Date Received
    April 30, 2009
    Date of Event
    June 11, 2007
    Report Date
    June 12, 2007
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    K032737
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING AN INTERNAL REVIEW, IT WAS NOTED THAT THIS EVENT WAS BELIEVED TO HAVE BEEN SENT VIA ALTERNATIVE SUMMARY REPORTING (ASR). HOWEVER, IT WAS NOT SUBMITTED ON THE ASR REPORT AS IT DID NOT MEET THE GUIDELINES FOR ASR REPORTING AT THE CURRENT TIME THE REPORT WAS SUBMITTED (JULY 2007). THEREFORE, A 3500A WAS GENERATED TO REPORT THIS EVENT. DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TO THE SUPERFICIAL FEMORAL ARTERY (SFA), THE BALLOON WAS REPORTED TO HAVE RUPTURED. THERE WAS NO REPORTED PT INJURY. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN (MQP). THIS REVIEW WAS EXTENDED TO SUBASSEMBLY (B) (4) WITH LOT NUMBER 0101070562. THIS REVIEW CONFIRMED THAT SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL, INCLUDING BURST TEST VALUES. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT THE RETURN OF THE PRODUCT OR FILMS OF THE PROCEDURE, IT IS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE BALLOON RUPTURED AT 5 ATMOSPHERES OF PRESSURE. THE LESION BEING TREATED WAS THE SUPERFICIAL FEMORAL ARTERY. ONCE THE POWERFLEX P3 ((B) (4)) BALLOON BURST, CONTRAST MEDIA WAS OBSERVED LEAKING FROM THE BALLOON. ANOTHER BALLOON (SAME SIZE) WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERFLEX P3 PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA R0207045

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PROCEDURE.| A .035 GLIDEWIRE WAS USED DURING THE INDEX