BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1150007 · Received August 27, 2008

    Report

    Report Number
    2024168-2008-00732
    Event Type
    Malfunction
    Date Received
    August 27, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 6, 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 CONCLUSIONS SUMMATION- PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. FACTOR THAT CAN CONTRIBUTE TO BALLOON RUPTURE INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, INTERACTION WITH OTHER DEVICES, PATIENT ANATOMY, LESION CALCIFICATION, OR LESION TORTUOSITY. IT WAS REPORTED THAT THE LESION WAS MILDLY TORTUOUS AND MODERATELY CALCIFIED 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 DISCREPANCY.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS LIKELY TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% RE-STENOSIS OF ANOTHER COMPANY'S STENT, IN THE PROXIMAL LCX. THERE WAS MILD TORTUOSITY AND MODERATE CALCIFICATION. THE 3.5 X 20 MM VOYAGER BALLOON CATHETER WAS DELIVERED, HOWEVER, DURING THE FIRST INFLATION THE BALLOON RUPTURED AT 10 ATM. ANOTHER COMPANY'S 3.5 X 15 MM BALLOON CATHETER WAS USED AND THE LESION WAS DILATED AT 20 ATM. NO ADD'L EVENT OR PATIENT INFORMATION 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 6101332

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GUIDE WIRE: ATHLETEGT| GUIDING CATHETER.| ACCESS 6F JL4| DILATATION CATHETER. 3.5 X 15 MM QUANTUM