BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1082061 · Received July 23, 2008

    Report

    Report Number
    2024168-2008-00594
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 22, 2008
    Report Date
    June 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION: PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. FACTORS THAT MAY CONTRIBUTE TO BALLOON DAMAGE MAY INCLUDE, BUT NOT LIMITED TO, MANUFACTURING, MATERIALS, PT ANATOMY, PT DISEASE STATE, ASSOCIATIVE DEVICE INTERACTION, LESION TORTUOSITY, OVER INFLATION, OR INSUFFICIENT PREPARATION PRIOR TO USE. THE DESCRIBED PT ANATOMY WAS MILD TORTUOUS AND MILDLY CALCIFIED, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. HOWEVER, WITHOUT THE DEVICE TO EXAMINE, A THROUGH ANALYSIS COULD NOT BE PERFORMED AND NO DETERMINATION CAN BE MADE AS TO THE ROOT CAUSE OF THE REPORTED DISCREPANCY.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE HAS PREVIOUSLY CAUSED OR CONTRIBUTED TO PT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE TARGET LESION HAD MILD TORTUOSITY, WAS MILDLY CALCIFIED, AND WAS ECCENTRIC WITH A 90% STENOSIS. A GUIDE WIRE CROSSED THE LEFT ANTERIOR DESCENDING AND THE 2.0 X 15 MM VOYAGER WAS ADVANCED. THERE WAS AN ATTEMPT TO INFLATE THE BALLOON; HOWEVER, IT WAS NOTICED THAT THE PRESSURE WAS NOT INCREASING ON THE INDEFLATOR. CONTRAST MEDIAL WAS LEAKING FROM THE BALLOON, SO IT WAS REMOVED FROM THE PATIENT'S BODY. THE BALLOON HAD RUPTURED AND THERE WAS BLOOD VISIBLE IN THE BALLOON. THE PROCEDURE WAS COMPLETED BY USING ANOTHER COMPANY'S 2.0X15MM BALLOON CATHETER. THERE IS NO ADDITIONAL EVENT OR PT INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 6091132

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DIL CATH: LACROSSE 2.0X15MM| PILOT 50 GUIDE CATH: 7F LAUNCHER EBU3.75| HIRYU 2.75X15MM| GUIDE WIRE: SUOH| STENT: CYPHER 2.5X18MM