BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2862596 · Received December 10, 2012

    Report

    Report Number
    2024168-2012-07765
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 12, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT DESCRIBED AS SLIGHTLY OBESE. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS AND THE REPORTED DIFFICULTY WAS CONFIRMED. BASED ON VISUAL, DIMENSIONAL AND FUNCTIONAL 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, WITH A BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE POSITIONED IN A CONCENTRIC, DE NOVO LESION IN THE NON-TORTUOUS MID RIGHT CORONARY ARTERY, DURING ADVANCEMENT, HALFWAY TOWARD THE GUIDING CATHETER, A 3.5X15 VOYAGER NC BALLOON DILATATION CATHETER (BDC) WAS NO LONGER ABLE BE FURTHER ADVANCED OVER THE BMW GUIDE WIRE. THE VOYAGER NC BDC WAS WITHDRAWN FROM THE BMW GUIDE WIRE WITH SOME RESISTANCE FELT, BUT NO FORCE WAS APPLIED. ANOTHER SAME SIZE VOYAGER NC WAS ABLE TO BE INTRODUCED AND DELIVERED OVER THE SAME BMW GUIDE WIRE TO THE TARGET LESION, SUCCESSFULLY TREATING THE TARGET LESION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. 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 2021461

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: BALANCE MIDDLEWEIGHT