BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE¿ WIREGUIDED

    MDR report key: 8057036 · Received November 9, 2018

    Report

    Report Number
    3005099803-2018-02627
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Date of Event
    April 18, 2018
    Report Date
    October 18, 2018
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    K112994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION RESULTS: A VISUAL EXAMINATION OF THE RETURNED COMPLAINT DEVICE FOUND THAT THE BALLOON WAS TORN LONGITUDINALLY. FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE FAILURE LIKELY OCCURRED DUE TO ANATOMICAL OR PROCEDURAL FACTORS WHICH LIMITED THE PERFORMANCE OF THE BALLOON. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED DURING A PROCEDURE ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN INFLATING THE BALLOON TO 6 ATM THE BALLOON BURST. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS REPORT WAS ORIGINALLY SUBMITTED AS PART OF ALTERNATIVE SUMMARY REPORTING (ASR) IN Q2-2018 UNDER PRODUCT CODE KNQ (EXEMPTION E2012013) AND CAN BE FOUND IN MANUFACTURER REPORT # 3005099803-2018-02481.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896753 CRE¿ WIREGUIDED BALLOON DILATOR KNQ BOSTON SCIENTIFIC - CORK M00558660 21207883

    Patients

    Seq Age Sex Outcome Treatment
    1