BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

    MDR report key: 2963831 · Received February 15, 2013

    Report

    Report Number
    2024168-2013-00888
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    REPORTEDLY, AFTER A NAV6 EMBOSHIELD FILTER WAS DEPLOYED IN THE LEFT INTERNAL CAROTID ARTERY WITH NO CALCIFICATION OR TORTUOSITY, A 5.0 X 20 MM VIATRAK BALLOON DILATATION CATHETER WAS PREPPED PER INSTRUCTIONS FOR USE AND ADVANCED FOR PRE-DILATATION WITHOUT DIFFICULTY. DURING INFLATION OF THE VIATRAK BALLOON, THE BALLOON RUPTURED AT 6 ATMOSPHERES (ATM) WHILE TRYING TO INCREASE THE PRESSURE TO 8 ATMS. THE BALLOON WAS WITHDRAWN WITHOUT DIFFICULTY; HOWEVER, WITHIN 10 SECONDS OF THE BALLOON RUPTURE, THE PATIENT BECAME INCOHERENT WITH NO RESPONSE TO QUESTIONS. THE PHYSICIAN WAS NOT SURE WHETHER THE PATIENT'S SYMPTOMS WERE DUE TO THE BALLOON RUPTURE OR POSSIBLY DUE TO THE FILTER BEING FULL OF DEBRIS CAUSING AN OCCLUSION IN THE FILTER, SO HE DEPLOYED A STENT AND THEN WITHDREW THE FILTER WHERE UPON THE PATIENT'S CONDITION RESOLVED. THE NAV6 EMBOSHIELD FILTER WAS EXAMINED OUTSIDE OF THE PATIENT ANATOMY AND IT WAS NOTED THAT THE FILTER WAS NOT FULL BUT RATHER ONLY ABOUT ONE FOURTH FULL. POST PROCEDURE, THE PATIENT APPEARED TO BE FINE. A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67043 RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 2042361

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR