BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSFORM COMPLIANT 4MM X 10MM

    MDR report key: 3872880 · Received June 13, 2014

    Report

    Report Number
    3008853977-2014-00183
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    MJN
    PMA / PMN Number
    K122576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THIS EVENT IS A DUPLICATE OF THE EVENT REPORTED UNDER MANUFACTURER REPORT NUMBER 3008853977-2014-00184. THE REPORTED ISSUE WITH THE DEVICE WILL BE INVESTIGATED UNDER THE COMPLAINT FILE ASSOCIATED WITH MANUFACTURER REPORT NUMBER 3008853977-2014-00184 AND THE INVESTIGATION RESULTS WILL BE REPORTED UNDER MANUFACTURER REPORT NUMBER 3008853977-2014-00184. THIS FOLLOW-UP MDR, UNDER MANUFACTURER REPORT NUMBER 3008853977-2014-00183 IS BEING FILED TO REPORT THAT THE EVENT IS A DUPLICATE OF MANUFACTURER REPORT NUMBER 3008853977-2014-00184 AND ALL FURTHER FOLLOW-UP MDR INFORMATION WILL BE FILED UNDER MANUFACTURER REPORT NUMBER 3008853977-2014-00184.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BALLOON ASSISTED COIL EMBOLIZATION, THE BALLOON WOULD NOT STAY INFLATED. THE PHYSICIAN ATTEMPTED TO INFLATE AND DEFLATE THE BALLOON SEVERAL TIMES BUT THE BALLOON LEAKED CONTRAST. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BALLOON ASSISTED COIL EMBOLIZATION, THE BALLOON WOULD NOT STAY INFLATED. THE PHYSICIAN ATTEMPTED TO INFLATE AND DEFLATE THE BALLOON SEVERAL TIMES BUT THE BALLOON LEAKED CONTRAST. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349664 TRANSFORM COMPLIANT 4MM X 10MM CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN STRYKER NEUROVASCULAR CORK 17382544

    Patients

    Seq Age Sex Outcome Treatment
    1 TRANSEND GUIDEWIRE (BOSTON SCIENTIFIC)