BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 2475029 · Received March 1, 2012

    Report

    Report Number
    2024168-2012-01310
    Event Type
    Malfunction
    Date Received
    March 1, 2012
    Date of Event
    February 7, 2012
    Report Date
    February 7, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED LABELING ON THE CHIPBOARD BOX NOT CORRESPONDING WITH THE LABEL AFFIXED TO THE POUCH AND THE BALLOON CATHETER WAS CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT-HANDLING DATABASE FROM THIS 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 AFTER UNPACKAGING WHAT WAS IDENTIFIED ON THE BOX TO BE A VOYAGER RX 2.5 X 12MM BALLOON, LOT# 1062061, A VOYAGER RX 2.5 X 15MM BALLOON WAS FOUND, LOT# 1070161. THE HUB OF THE CATHETER AND THE PLASTIC PACKAGING ARE BOTH 2.5 X 15MM. REPORTEDLY, THE BOX SEAL WAS INTACT AND THE BOX DID NOT APPEAR TO BE TAMPERED WITH OR PREVIOUSLY OPENED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1062061

    Patients

    Seq Age Sex Outcome Treatment
    1