BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1852099 · Received September 28, 2010

    Report

    Report Number
    2024168-2010-02027
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 3, 2010
    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

    (B)(4). BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, HANDLING, LESION CHARACTERISTICS, PATIENT DISEASE STATE, AN INTERACTION WITH A PREVIOUSLY IMPLANTED STENT, INSUFFICIENT PREPARATION PRIOR TO USE OR FROM INTERACTION WITH OTHER DEVICES. THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS MAY INDICATE THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. IF THE BALLOON EXPERIENCES MECHANICAL DAMAGE AT SOME POINT DURING THE PROCEDURE, THIS CAN CAUSE THE MATERIAL TO WEAKEN AND RUPTURE DURING AN ATTEMPT TO INFLATE THE CATHETER. BASED ON THE INFORMATION RECEIVED, A DEFINITIVE CAUSE OF THE REPORTED BALLOON RUPTURE CANNOT BE DETERMINED, HOWEVER, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VOYAGER RX WAS ADVANCED TO THE LESION FOR PRE-DILATATION. HOWEVER, THE BALLOON RUPTURED AT 6 ATMOSPHERES WHEN INFLATED FOR THE FIRST TIME. NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL 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 0031561

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: DRIVER 4.0-24| GUIDE CATH: ASAHISHEATHLESS| GUIDE WIRE: SION| DIL CATH: MAVERICK II 4.0