BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIFLEX?

    MDR report key: 3840320 · Received May 30, 2014

    Report

    Report Number
    3005099803-2014-02020
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S AGE IS UNKNOWN; HOWEVER THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OF AGE. (B)(4) FOR THE EVENT: WIRE DETACHED. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SMALL OVAL SNARE WAS USED DURING A COLONOSCOPY/POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE METAL WIRE DISCONNECTED FROM THE HANDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318161 CAPTIFLEX? SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562422 14973195

    Patients

    Seq Age Sex Outcome Treatment
    1