BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1250083 · Received November 14, 2008

    Report

    Report Number
    2024168-2008-01154
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 17, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    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, INTERACTION WITH OTHER DEVICES, PT ANATOMY, LESION CALCIFICATION, OR LESION TORTUOSITY. IT WAS REPORTED THAT THE LESION WAS MILDLY TORTUOUS, MILDLY CALCIFIED AND 100% STENOSED, WHICH COULD HAVE CONTRIBUTED TO THE BALLOON RUPTURE. WITHOUT THE DEVICE TO EXAMINE, A THOROUGH ANALYSIS COULD NOT BE PERFORMED, AND NO DETERMINATION CAN BE MADE AS TO THE ROOT CAUSE OF THE REPORTED BALLOON RUPTURE.

    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 THE FIRST INFLATION THE VOYAGER BALLOON RUPTURED. THE LESION WAS DILATED USING A ANOTHER COMPANY'S BALLOON CATHETER AND A DRUG ELUTING STENT WAS IMPLANTED AT THE LESION SITE. 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 MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 8061142

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK