BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 992537 · Received February 5, 2008

    Report

    Report Number
    2024168-2008-00072
    Event Type
    Malfunction
    Date Received
    February 5, 2008
    Date of Event
    January 7, 2008
    Report Date
    January 8, 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

    THE SECOND VOYAGER MENTIONED IS BEING FILED UNDER THE SAME MANUFACTURER NUMBER. RESULTS AND CONCLUSION SUMMATION - QUALITY ENGINEERING REVIEWED THE INCIDENT INFO. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURE INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, INTERACTIONS WITH OTHER DEVICES, PT ANATOMY, LESION CALCIFICATION, TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. THE LESION IN THE INCIDENT WAS HEAVILY CALCIFIED AND 90% STENOSED, WHICH COULD HAVE CONTRIBUTED TO MECHANICALLY DAMAGING THE BALLOON SURFACES SUCH THAT UPON INFLATION, THE BALLOONS RUPTURED. WITHOUT THE DEVICES RETURNED FOR ANALYSIS, NO ROOT CAUSE CAN BE DETERMINED FOR THE BALLOON RUPTURES.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS LIKELY TO CAUSE OR CONTRIBUTE TO A PT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE TARGET LESION WAS THE MID-DISTAL RIGHT CORONARY ARTERY (RCA) WHICH HAD MILD TORTUOSITY, HEAVY CALCIFICATION, AND 90% STENOSIS. THE VESSEL DIAMETER WAS 3.0MM. IT WAS AN ACUTE MYOCARDIAL INFARCTION CASE. ANOTHER COMPANY'S GUIDE WIRE WAS CROSSED TO THE LESION AND THEN A VOYAGER 2.0 X 20 (LOT # 7040531) WAS DELIVERED. THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 14 ATM. ANOTHER VOYAGER (2.5X20, LOT # 7091734) WAS USED; HOWEVER, IT ALSO RUPTURED AT THE FIRST INFLATION AT 10 ATM. A STENT WAS DEPLOYED AND ANOTHER COMPANY'S BALLOON CATHETER WAS USED TO POST-DILATE. THE PROCEDURE WAS COMPLETED AND 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 74LOX LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 7040531

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DILATATION CATHETER: RX VOYAGER 2.5 X 20| RUNTHROUGH/TERUMO| (PART# 1011394-20/LOT# 7091734)| STENT: DRIVER/MEDTRONIC| GUIDING CATHETER: LUNCHER/MEDTRONIC| HIRYU/TERUMO| GUIDEWIRE: NEO'S RINATO/GETZ (ASAHI INTECC)