BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMIRAL XTREME US

    MDR report key: 2963465 · Received February 15, 2013

    Report

    Report Number
    3004066202-2013-00013
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 17, 2013
    Report Date
    February 14, 2013
    Manufacturer
    INVATEC SPA
    Product Code
    LIT
    PMA / PMN Number
    K062809
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: PATIENT CONDITIONS AFFECTED EFFECTIVENESS OF THE DEVICE (LONG CALCIFIED LESION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LONG CALCIFIED LESION). (B)(4).

    Description of Event or Problem · 1

    DEVICE EVALUATION: THE CATHETER RETURNED TO THE MANUFACTURING FACILITY. THE BALLOON WAS NOT FOLDED AND NO DAMAGE WAS PRESENT ALONG THE SHAFT OF THE CATHETER. THE CATHETER WAS FLUSHED AND A 0.035" GUIDE WIRE WAS INSERTED AND NO ISSUES WERE NOTED. THE BALLOON CATHETER WAS INFLATED AND A LEAKAGE APPEARED FROM A PINHOLE IN THE CYLINDRICAL PORTION OF THE BALLOON AT AROUND 5CM FROM THE PROXIMAL CONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE AN ADMIRAL EXTREME PTA BALLOON CATHETER TO TREAT A LONG CALCIFIED LESION IN THE SFA. IT WAS REPORTED THAT THE BALLOON REACHED NOMINAL PRESSURE AND DILATED THE LESION, THEN, WHEN THE PHYSICIAN WENT TO PULL THE BALLOON DOWN, BLOOD WENT INTO THE BALLOON AND INTO THE SYRINGE AND IT WAS NOTED THAT THE BALLOON WAS BROKEN. THE PHYSICIAN WAS ABLE TO REMOVE THE BALLOON WITHOUT ANY PROBLEMS. THE PATIENT WAS REPORTED TO BE FINE AFTER THE PROCEDURE. NO PATIENT INJURY WAS REPORTED AND NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66261 ADMIRAL XTREME US CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT INVATEC SPA 1B031166

    Patients

    Seq Age Sex Outcome Treatment
    1