BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2863367 · Received December 10, 2012

    Report

    Report Number
    2024168-2012-07784
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    September 23, 2012
    Report Date
    September 24, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED DIFFICULTY ADVANCING COULD NOT BE REPLICATED AS IT WAS BASED ON CASE CIRCUMSTANCES. THE REPORTED KINKS WERE CONFIRMED. THERE WAS BALLOON PEELING AT THE DISTAL TAPER OF THE BALLOON, LIKELY DUE TO INTERACTION WITH THE HEAVY LESION CALCIFICATION. BASED ON VISUAL AND 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 THE PROCEDURE WAS TO TREAT A 95% STENOSIS IN THE LEFT CIRCUMFLEX (LCX). THERE WAS DIFFICULTY ADVANCING THE VOYAGER, BUT IF FINALLY DID CROSS THE LESION. THE PROXIMAL SHAFT WAS KINKED DUE TO THE VESSEL ANATOMY, SO THE PHYSICIAN ONLY INFLATED TO A LOW PRESSURE (UNKNOWN PRESSURE) AND THEN REMOVED THE CATHETER WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REFERRED TO MEDICAL MANAGEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE ANALYSIS REVEALED PEELING ON THE DISTAL END OF THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1080461

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR