BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER LEGEND RX BALLOON DILATATION CATHETER

    MDR report key: 1890160 · Received October 22, 2010

    Report

    Report Number
    2953200-2010-02038
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DISTAL TIP WAS DAMAGED AND PARTIALLY BUNCHED ON ONE SIDE INDICATING THAT IT MAY HAVE BEEN STUBBED DURING ADVANCEMENT. NEGATIVE PURGE DID NOT DETECT THE PRESENCE OF A LEAK POSSIBLY DUE TO THE PRESENCE OF CRYSTALLIZED RESIDUE IN THE INFLATION LUMEN AND BALLOON. THE DEVICE WAS PLACED IN A WATER BATH TO DISPERSE THE RESIDUE. ON REMOVAL FROM THE WATER BATH, A NEGATIVE PREP WAS CARRIED OUT ON THE DEVICE AND A CONSTANT STREAM OF AIR BUBBLES WAS SEEN TO ENTER THE SYRINGE CONFIRMING THE PRESENCE OF A LEAK IN THE DEVICE. WHEN AN ATTEMPT WAS MADE TO INFLATE THE DEVICE USING AN INDEFLATOR, THE DEVICE WOULD NOT HOLD PRESSURE. A SMALL RADIAL TEAR WAS LOCATED ON THE BALLOON OVER THE DISTAL END OF THE INNER SHAFT MARKER. (B)(4). EVALUATION: RESULTS: (HEAVY CALCIFICATION), (FORCE USED DURING ADVANCEMENT OF THE DEVICE). CONCLUSIONS: (HEAVY CALCIFICATION), (COMPLEX PROCEDURE).

    Description of Event or Problem · 1

    A 1.5 MM DIAMETER X 10 MM LENGTH SPRINTER LEGEND RAPID EXCHANGE (RX) BALLOON DILATATION CATHETER WAS USED IN A PT TO PRE-DILATE A HEAVILY CALCIFIED LESION LOCATED IN THE RCA. INFORMATION REC'D FROM THE ACCOUNT CONFIRMED THAT PRIOR TO THIS; THE PHYSICIAN HAD FAILED TO DELIVER TWO OTHER PRE-DILATION BALLOONS (DETAILS UNK). RESISTANCE WAS ENCOUNTERED AND FORCE WAS APPLIED TO THE RELEVANT DEVICE DURING ITS ADVANCEMENT; HOWEVER, IT WAS REPORTED THAT THE BALLOON RUPTURED WHEN INFLATED TO 14 ATMS. DURING PROCEDURE, ONE OTHER SPRINTER LEGEND RX BALLOON WAS USED FOR PRE DILATION PURPOSES, HOWEVER, THIS BALLOON ALSO RUPTURED WHEN INFLATED TO 14ATMS (MFR TEMPT #2953200-2010-02039). THE PT IS REPORTED TO BE FINE AND NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINTER LEGEND RX BALLOON DILATATION CATHETER LOX MEDTRONIC CARDIOVASCULAR GALWAY NA 0002336696

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR