BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1034043 · Received April 24, 2008

    Report

    Report Number
    2024168-2008-00341
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    March 27, 2008
    Report Date
    March 27, 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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VOYAGER BALLOON CATHETER (1011392-15/UNK LOT#) MENTIONED THE EVENT DESCRIPTION AS THE FIRST VOYAGER USED IN THE PROCEDURE IS BEING FILED UNDER ANOTHER MFR#.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS LIKELY TO CAUSE OR CONTRIBUTE TO PT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT DURING TREATMENT FOR IN-STENT RESTENOSIS OF ANOTHER COMPANY'S STENT, THE VOYAGER BALLOON RUPTURED AT 14 ATM. THIS WAS THE SECOND VOYAGER TO RUPTURE DURING THIS PROCEDURE. THE FIRST WAS ALSO A VOYAGER BALLOON CATHETER THAT RUPTURED AT 16 ATM (ABOVE RATED BURST PRESSURE). THE PHYSICIAN BELIEVED THE BALLOON MAY HAVE RUPTURED BECAUSE OF STENT STRUTS PROTRUDING INTO THE LESION. REPORTEDLY, THERE WERE NO PT EFFECTS. NO ADD'L 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 8011631

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK VOYAGER (1011392-15/UNK LOT#)