BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACIFIC XTREME PTA BALLOON CATHETER

    MDR report key: 2172634 · Received June 23, 2011

    Report

    Report Number
    3004066202-2011-00029
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    INVATEC INNOVATIVE TECHNOLOGIES SPA
    Product Code
    LIT
    PMA / PMN Number
    K103464
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL, RESULTS: (BALLOON BURST), (MODERATELY CALCIFIED, MILDLY TORTUOUS LESION). EVAL CODES, CONCLUSION: (MODERATELY CALCIFIED, MILDLY TORTUOUS LESION). EVAL SUMMARY: THE DEVICE WAS RETURNED. VISUAL INSPECTION CONFIRMED A LARGE LONGITUDINAL CUT AS A RESULT OF THE BURST REPORTED BY THE PHYSICIAN. NO PART OF THE BALLOON HAS DETACHED.

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO USE A PACIFIC XTREME PTA BALLOON CATHETER TO TREAT A MODERATELY CALCIFIED LESION IN A MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY WITH 90% STENOSIS. THE BALLOON RUPTURED AFTER BEING INFLATED 14 TIMES. THERE WAS NO HEALTH HAZARD CAUSED TO THE PT. THE PCI PROCEDURE WAS FINISHED AFTER THE BALLOON RUPTURE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACIFIC XTREME PTA BALLOON CATHETER LIT INVATEC INNOVATIVE TECHNOLOGIES SPA NA 1A006109

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK