BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER OTW CORONARY DILATATION CATHETER

    MDR report key: 1051192 · Received May 22, 2008

    Report

    Report Number
    2024168-2008-00415
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 24, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION: PRODUCT PERFORMANCE ENGINEERING DETERMINED THAT THE FACTORS THAT CAN CONTRIBUTED TO BALLOON RUPTURE INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, INTERACTIONS WITH OTHER DEVICES, PATIENT ANATOMY, LESION CALCIFICATION, LESION TORTUOSITY, EXCESSIVE APPLIED PRESSURE, OR INSUFFICIENT PREPARATION PRIOR TO USE. IT WAS REPORTED THAT THE LESION TREATED IN THE PROCEDURE WAS MILDLY CALCIFIED, WHICH COULD HAVE CONTRIBUTED TO DAMAGING THE SURFACE OF THE BALLOON SUCH THAT UPON INFLATION, THE BALLOON RUPTURED; HOWEVER, WITHOUT A RETURNED DEVICE FOR ANALYSIS, A DEFINITE 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 VOYAGER OTW WAS CROSSED TO THE LESION; HOWEVER, IT RUPTURED AT 3 ATM, WHEN IT WAS INFLATED FOR THE FIRST TIME. THE LESION WAS DILATED WITH A 1.5 X 15 MM VOYAGER RX BALLOON CATHETER AND THEN WITH A 3.0 X 15 MM NC MERCURY. THE PROCEDURE WAS COMPLETED AFTER DEPLOYING A 3.0 X 18 MM VISION STENT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER OTW CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 7012951

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STENT: VISION 3.0-18| GUIDE CATHETER: MACH1 JR4| DILATATION CATHETER: VOYAGER RX 1.5 X 15| GUIDE WIRE: PILOT 50