BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1032288 · Received April 21, 2008

    Report

    Report Number
    2024168-2008-00333
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 28, 2008
    Report Date
    March 28, 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 CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURE INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, INTERACTIONS WITH OTHER DEVICES, PATIENT ANATOMY, LESION CALCIFICATION, LESION TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. IN THIS CASE, IT IS POSSIBLE THAT AN INTERACTION WITH THE STENT IMPLANT CONTRIBUTED TO MECHANICALLY DAMAGING THE SURFACE OF THE BALLOON SUCH THAT UPON INFLATION, THE DEVICE RUPTURED. WITHOUT THE DEVICE FOR ANALYSIS, A DEFINITE ROOT CAUSE FOR THE BALLOON RUPTURE CANNOT BE DETERMINED.

    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 AFTER PRE-DILATATION WAS PERFORMED, ANOTHER COMPANY'S STENT WAS DEPLOYED. THEN THE RX VOYAGER WAS ENGAGED FOR POST-DILATATION; HOWEVER, DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 12 ATM. ANOTHER COMPANY'S STENT WAS PLACED AND THE PROCEDURE WAS COMPLETED. NO ADDITIONAL 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 6112832

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STENT: HIRYU 3.5X10