BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2863218 · Received December 10, 2012

    Report

    Report Number
    2024168-2012-07743
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    October 21, 2012
    Report Date
    November 3, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EXCESSIVE FORCE. THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED FAILURE TO ADVANCE COULD NOT BE REPLICATED AS IT WAS BASED ON CASE CIRCUMSTANCES. THE REPORTED SEPARATION WAS CONFIRMED. BASED ON VISUAL AND DIMENSIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THAT THE NC VOYAGER INSTRUCTION FOR USE (IFU) STATES, IF RESISTANCE IS FELT, DETERMINE THE CAUSE BEFORE PROCEEDING. CONTINUING TO ADVANCE OR RETRACT THE CATHETER WHILE UNDER RESISTANCE MAY RESULT IN DAMAGE TO THE VESSELS AND / OR DAMAGE / SEPARATION OF THE CATHETER. IN THIS CASE, CONTINUING TO ADVANCE THE CATHETER AGAINST RESISTANCE WITH FORCE APPEARS TO HAVE CAUSED THE SEPARATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH HEAVY TORTUOSITY AND HEAVY CALCIFICATION. THE 3.5 X 15 MM VOYAGER NC BALLOON CATHETER WAS ADVANCED, BUT COULD NOT CROSS THE LESION. IT WAS NOTED THAT STRONG RESISTANCE WAS NOTED WITH THE TORTUOUS SEGMENT OF THE VESSEL. A NEW VOYAGER NC BALLOON WAS USED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS FOUND THAT THE HYPOTUBE WAS SEPARATED. ADDITIONAL INFORMATION REPORTED THAT DURING THE ATTEMPT TO CROSS THE SEVERE CALCIFICATION, FORCE WAS USED AND THE HYPOTUBE SEPARATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1091361

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR