BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1890301 · Received October 22, 2010

    Report

    Report Number
    2024168-2010-02231
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 28, 2010
    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

    (B)(4). FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURES INCLUDE, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MFG, WEAK MATERIALS, EXCESSIVELY APPLIED PRESSURE, OR INTERACTIONS WITH ACCESSORY DEVICES, PT ANATOMY, AND/OR LESION CALCIFICATION OR TORTUOSITY. THE PT ANATOMY WAS MILDLY TORTUOUS AND CALCIFIED AND THE DEVICE WAS USED TO POST DILATE A STENT, WHICH LIKELY CONTRIBUTED TO THE RUPTURE. IT IS POSSIBLE THE BALLOON MATERIAL WAS DAMAGED DURING INTERACTIONS WITH OTHER DEVICES, OR PT ANATOMY, SUCH THAT THE BALLOON RUPTURED UPON INFLATION. REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. THE DEVICE WAS NOT RETURNED; THEREFORE, NO CONCLUSIVE CAUSE COULD BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA), WHICH WAS MILDLY TORTUOUS, HEAVILY CALCIFIED AND HAD A 90% STENOSIS. A ROTABLATOR WAS USED IN THE LESION AND A XIENCE V WAS IMPLANTED. THEN, THE VOYAGER NC BALLOON CATHETER WAS USED FOR POST-DILATATION, BUT THE BALLOON RUPTURED WHEN INFLATED FOR THE SECOND TIME. THEN, INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AND THE STENT WAS CONFIRMED TO BE ADEQUATELY EXPANDED. REPORTEDLY, THERE WERE NO PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 9050461

    Patients

    Seq Age Sex Outcome Treatment
    1 DIL CATH: VOYAGER| STENT: XIENCE V| GUIDE WIRE: RUNTHROUGH| GUIDE CATH: FINECROSS| GUIDE CATH: ROTA