BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER OTW CORONARY DILATATION CATHETER

    MDR report key: 1051191 · Received May 22, 2008

    Report

    Report Number
    2024168-2008-00416
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 23, 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 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, OR INSUFFICIENT PREPARATION PRIOR TO USE. REPORTEDLY, THE LESION TREATED IN THIS INCIDENT WAS MODERATELY CALCIFIED, WHICH COULD HAVE CONTRIBUTED TO MECHANICALLY 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 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 THE TARGET LESION WAS THE DISTAL RCA WITH MILD TORTUOSITY, MODERATE CALCIFICATION AND 90% STENOSIS. AFTER CROSSING ANOTHER COMPANY'S GUIDE WIRE, THE VOYAGER OTW WAS DELIVERED AND INFLATED; HOWEVER, IT RUPTURED AT THE FIRST INFLATION, AT 10 ATM. IT WAS NOTED THAT THE RUPTURE MAY BE DUE TO THE CALCIFICATION OR QUALITY PROBLEM; THEREFORE, THE BALLOON WAS CHANGED TO ANOTHER COMPANY'S BALLOON. ANOTHER COMPANY'S STENT WAS IMPLANTED 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 OTW CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 5110751

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GUIDE WIRE: RUNTHROUGH HYPERCOAT| STENT: MICRO DRIVER 2.5 X 18| GUIDE CATHETER: LAUNCHER 6F JR2.0| DILATATION CATHETER: QUANTUM MAVERICK2 2.0 X 15