BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1299183 · Received December 4, 2008

    Report

    Report Number
    2024168-2008-01280
    Event Type
    Malfunction
    Date Received
    December 4, 2008
    Date of Event
    November 4, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P810046
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE PART # (1011759-08) LOT # (8050961) OF THE RECALLED PRODUCT WAS ENTERED IN ORDER TO PRODUCE THIS MEDWATCH REPORT. ALL OF THE PART AND LOT #S OF THE RECALLED PRODUCT ARE ARE BEING FILED UNDER THE SAME MFR #.

    Description of Event or Problem · 1

    ON NOV 4, 2008, ABBOTT VASCULAR CARDIAC THERAPIES INITIATED A RECALL. IN A SMALL PERCENTAGE OF CASES, IT WAS REPORTED THAT THE BALLOON PACKAGING SHEATH OF THE 4.5 MM DIAMETER VOYAGER NC HAS BEEN "TIGHT" DURING REMOVAL. THIS POSES A POTENTIAL RISK OF DAMAGE TO THE BALLOON DILATATION CATHETER THAT MAY NOT BE IDENTIFIED PRIOR TO USE. ABBOTT VASCULAR HAS INITIATED A VOLUNTARY RECALL OF THE 4.5 MM VOYAGER NC CORONARY DILATATION CATHETER. THE QUALITY ISSUE WAS IDENTIFIED THROUGH ROUTINE MONITORING OF ABBOTT VASCULAR'S PRODUCT EXPERIENCE REPORTING SYSTEM. NO SIGNIFICANT ADVERSE EVENTS HAVE BEEN REPORTED WITH THE AFFECTED LOTS IN ANY PTS AT THIS TIME, AND THIS RECALL DOES NOT AFFECT ANY PT WHO HAVE ALREADY BEEN TREATED WITH THE 4.5 MM DIAMETER VOYAGER NC. THIS ACTION DOES NOT AFFECT ANY OTHER SIZES OF THE VOYAGER NC DILATATION CATHETER PRODUCT LINE. RECALLED PRODUCT: VOYAGER NC 4.5X8MM, PART # 1011759-08, LOT # 8050961 AND 8062361. VOYAGER NC 4.5X12MM, PART # 1011759-12, LOT # 8041051, 8050561, 8061961 AND 8100761.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 8050961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA VOYAGER NC 4.5X8MM| VOYAGER NC 4.5X12MM| LOT # 8050961 AND 8062361| LOT # 8041051