BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1053468 · Received May 28, 2008

    Report

    Report Number
    2024168-2008-00427
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 28, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION- PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURE INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MFG, MATERIALS, INTERACTIONS WITH OTHER DEVICES, PT ANATOMY, LESION CALCIFICATIONS, LESION TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. REPORTEDLY, THE LESION TREATED IN THIS PROCEDURE WAS HEAVILY CALCIFIED, WHICH COULD HAVE CONTRIBUTED TO MECHANICALLY DAMAGING THE SURFACE OF THE BALLOON SUCH THAT UPON INFLATION THE BALLOON RUPTURED. A DEFINITE ROOT CAUSE FOR THE BALLOON RUPTURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS CONSIDERED LIKELY TO CAUSE OR CONTRIBUTE TO PT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE VOYAGER WAS INFLATED BUT THE BALLOON RUPTURED AT 3 ATM DURING THE FIRST PRE-DILATATION. ANOTHER VOYAGER WAS USED AND THE PROCEDURE WAS COMPLETED WITH IMPLANTING ANOTHER COMPANY'S STENT. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 7091233

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STENT: CYPHER