BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERSAIL CORONARY DILATATION CATHETER

    MDR report key: 1063753 · Received June 18, 2008

    Report

    Report Number
    2024168-2008-00495
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 19, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION- PRODUCT PERFORMANCE ENGINEERING DETERMINED THAT THE POWERSAIL INSTRUCTIONS FOR USE INDICATE THAT THE DEVICES SHOULD BE USED IN THE CORONARY VASCULATURE. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURE INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MFG, MATERIAL, INTERACTIONS WITH OTHER DEVICES, PT ANATOMY, LESION CALCIFICATION, LESION TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. IN THIS CASE, THE LESION WAS DESCRIBED AS HEAVILY CALCIFIED, WHICH SUGGESTS THAT AN INTERACTION WITH THE CALCIFICATION MAY HAVE LED TO THE BALLOON RUPTURES. FURTHERMORE, SINCE ALL THREE DEVICES RUPTURED, THIS SUGGESTS THAT SOME ASPECT OF THE PROCEDURE CONTRIBUTED TO THE RUPTURES; HOWEVER, WITHOUT THE DEVICES RETURNED FOR ANALYSIS, A DEFINITE ROOT CAUSE FOR THE BALLOON RUPTURES CANNOT BE DETERMINED. THE SECOND POWERSAIL DILIATION CATHETER INDICATED IN B5 AND D11 IS BEING FILED UNDER THE SAME MFG NUMBER. THE VOYAGER DILATATION CATHETER IS BEING FILED UNDER ANOTHER MFG NUMBER.

    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 THE DEVICES WERE USED IN A HEAVILY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA), WHICH IS CONSIDERED OFF LABEL USE. DURING TREATMENT OF THE LESION, ALL THREE BALLOONS (VOYAGER 2.5X12, POWERSAIL 3.0X28, POWERSAIL 3.0X28) RUPTURED BELOW NOMINAL PRESSURE. NO PT EFFECTS WERE REPORTED. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERSAIL CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 7071851

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DILATATION CATHETER: VOYAGER 2.5X 12| POWERSAIL 3.0X 28