BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1163383 · Received September 10, 2008

    Report

    Report Number
    2024168-2008-00784
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 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
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. THERE WERE NO ADVERSE PATIENT EFFECTS OBSERVED AS A RESULT OF THE BALLOON RUPTURE. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURES INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, INTERACTIONS WITH OTHER DEVICES, PATIENT ANATOMY, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. IN THIS CASE, THE PT ANATOMY WAS NOT DESCRIBED, WHICH MAY HAVE AIDED THE INVESTIGATION. UNFORTUNATELY, WITHOUT THE RETURNED DEVICE FOR ANALYSIS, A CONCLUSIVE ROOT CAUSE FOR THE BALLOON RUPTURE COULD NOT 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 THE RX VOYAGER BALLOON RUPTURED AT 12 ATM. ANOTHER RX VOYAGER BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. REPORTEDLY, THERE WERE NO PATIENT EFFECTS. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 8030632

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DIL CATH: VOYAGER