BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMIRAL XTREME OTW

    MDR report key: 3893232 · Received June 25, 2014

    Report

    Report Number
    3004066202-2014-00093
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 27, 2014
    Report Date
    July 14, 2014
    Manufacturer
    INVATEC SPA
    Product Code
    LIT
    PMA / PMN Number
    K062809
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: (ROOT CAUSE UNDETERMINED). NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). DEVICE NOT RETURNED. EVALUATION CONCLUSION: UNABLE TO CONFIRM COMPLAINT (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). (ROOT CAUSE UNDETERMINED). (B)(4).

    Additional Manufacturer Narrative · 1

    RELATED TO OPERATIONAL CONTEXT - USE OF THE DEVICE IN A LESION WITH CRITICAL ISCHEMIA.

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO USE AN ADMIRAL XTREME OTW PTA BALLOON CATHETER. DURING THE PROCEDURE THE BALLOON RUPTURED WHEN INFLATED TO 12ATM. NO ADVERSE EVENT/CLINICAL CONSEQUENCES AS A RESULT OF THE BALLOON RUPTURE.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE DEVICE WAS RETURNED WITH ITS ORIGINAL PACKAGING. CLOTTED BLOOD WAS EVIDENT ALONG THE SHAFT, INSIDE THE BALLOON SURFACE AND INSIDE THE HUB. IT WAS NOT POSSIBLE TO CLEAN THE DEVICE AS THE CLOTTED BLOOD OBSTRUCTED THE INFLATION LUMEN, PREVENTING THE POSSIBILITY TO FLUSH THE INNER LUMEN OR INFLATE THE BALLOON. NO DAMAGES WERE PRESENT ALONG THE SHAFT OR AT THE TIP. THE BALLOON APPEARS UNFOLDED; A SMALL BALLOON RUPTURE AT AROUND 30MM FROM THE PROXIMAL BALLOON SHOULDER (TRANSITION BETWEEN THE CYLINDRICAL PORTION AND THE DISTAL CONE) WAS EVIDENT. THE PINHOLE WITH THE BALLOON NOT INFLATED MEASURED APPROXIMATELY 0.5MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371492 ADMIRAL XTREME OTW CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT INVATEC SPA 1E004762

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR