BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 4122496 · Received September 26, 2014

    Report

    Report Number
    2024168-2014-06229
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 1, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED BALLOON RUPTURE WAS CONFIRMED. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE HEAVILY CALCIFIED, 99% STENOSED, NARROW, MID LEFT ANTERIOR DESCENDING (LAD) ARTERY THE 2.5 X 20 MM VOYAGER BALLOON DILATATION CATHETER (BDC) WAS USED FOR PREDILATATION, HOWEVER, DURING THE INFLATION ATTEMPT THE BALLOON DID NOT INFLATE; A SECOND INFLATION ATTEMPT TO 12 ATMOSPHERE (ATM) WAS UNSUCCESSFUL AND THE BALLOON DID NOT DILATE THE LESION. THE DEVICE WAS REMOVED FROM THE ANATOMY AND A BALLOON RUPTURE WAS NOTED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. A DIFFERENT 2.5 X 20 MM VOYAGER BDC WAS USED SUCCESSFULLY TO PRE-DILATATE THE LESION WITHOUT ISSUE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600659 VOYAGER RX CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1100461

    Patients

    Seq Age Sex Outcome Treatment
    1