BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVATOR? II

    MDR report key: 3901360 · Received June 30, 2014

    Report

    Report Number
    3005099803-2014-02291
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S AGE IS UNKNOWN; HOWEVER, THE PATIENT WAS OVER 18 YEARS OF AGE. REPORTED EVENT OF SNARE WIRE SPARKED. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON 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

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2014-02291, MANUFACTURER REPORT # 3005099803-2014-02292 AND MANUFACTURER REPORT # 3005099803-2014-02293 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE CAPTIVATOR EXTRA LARGE ROUND SNARES WERE USED DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE USER EXTENDED THE FIRST SNARE ONLY PARTIALLY AND APPLIED CURRENT WHEN SPARKS WERE SEEN COMING FROM THE DISTAL END OF THE SNARE WIRE. THE SAME FAILURE OCCURRED WITH THE OTHER TWO SNARE DEVICES. THE USER SUSPECTED THE ISSUE OCCURRED DUE TO THE GENERATOR, BUT COULD NOT CONFIRM. 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379982 CAPTIVATOR? II SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00561291 0016554758

    Patients

    Seq Age Sex Outcome Treatment
    1