BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMIRAL XTREME

    MDR report key: 3191979 · Received June 27, 2013

    Report

    Report Number
    3004066202-2013-00103
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 20, 2013
    Report Date
    June 25, 2013
    Manufacturer
    INVATEC SPA
    Product Code
    LIT
    PMA / PMN Number
    K062809
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES, RESULTS: UNKNOWN-ROOT CAUSE OF THE ISSUE IS UNDETERMINED. CONCLUSION: UNKNOWN-ROOT CAUSE OF THE ISSUE IS UNDETERMINED; CONCLUSION NOT YET AVAILABLE: EVALUATION IN PROGRESS. (B)(4).

    Additional Manufacturer Narrative · 1

    OTHER (ROOT CAUSE OF EVENT DUE TO A COMBINATION OF PROCEDURAL FACTORS). OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO USE AN ADMIRAL XTREME BALLOON TO PRE-DILATE A LESION LOCATED IN THE FEMORAL ARTERY. THE DEVICE WAS INSPECTED AND FLUSHED PRIOR TO USE WITH NO ISSUES NOTED HOWEVER NEGATIVE PREP WAS NOT PERFORMED. DURING INFLATION WHEN ATTEMPTING TO INFLATE THE BALLOON TO 7ATMS, A LEAKAGE WAS NOTED FROM THE BALLOON. THE BALLOON WAS REMOVED AND ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT WAS FINE POST PROCEDURE. NO CLINICAL SEQUELAE REPORTED.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE BALLOON IS CONFIRMED TO HAVE BEEN INFLATED AND IT SHOWS A LONGITUDINAL BURST. NO OTHER DAMAGES ARE PRESENT ALL ALONG THE DEVICE. NO ISSUES HAVE BEEN IDENTIFIED IN RELATION TO THE DEVICE TIP AND THE PROXIMAL BALLOON BOND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293736 ADMIRAL XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT INVATEC SPA 1D009336

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR