BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX HERCULINK ELITE STENT SYSTEM

    MDR report key: 2964026 · Received February 15, 2013

    Report

    Report Number
    2024168-2013-00897
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 23, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIN
    PMA / PMN Number
    P110001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE LEAK WAS ABLE TO BE CONFIRMED AS THERE WAS A TEAR IN THE SHAFT. BASED ON A VISUAL AND FUNCTIONAL INSPECTION 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 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

    IT WAS REPORTED THAT AFTER PREPPING A 6.0 MM X 15 MM X 80 CM RX HERCULINK ELITE RENAL STENT SYSTEM WITH CONTRAST, THE RX HERCULINK ELITE WAS ADVANCED INTO A GUIDING CATHETER PLACED IN THE VESSEL ACCESS SITE, WITHOUT RESISTANCE. WHILE STILL INSIDE OF THE GUIDING CATHETER AND BEFORE ENTERING THE PATIENT VESSEL, AS NEGATIVE PRESSURE WAS UNABLE TO BE MAINTAINED, THE RX HERCULINK ELITE WAS WITHDRAWN FROM THE ANATOMY AND AIR BUBBLES WERE NOTED TO BE ENTERING A PINHOLE IN THE BALLOON. NO RESISTANCE HAD BEEN NOTED DURING REMOVAL OF THE PROTECTIVE SHEATH. THE DEVICE WAS WITHDRAWN FROM THE GUIDING CATHETER WITHOUT RESISTANCE AND ANOTHER SAME SIZE RX HERCULINK ELITE WAS USED TO COMPLETE THE PROCEDURE. NO CLINICALLY SIGNIFICANT DELAY OCCURRED AND THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69165 RX HERCULINK ELITE STENT SYSTEM STENT SYSTEM NIN AV-TEMECULA-CT 1062961

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR