BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPTIVATOR? II

    MDR report key: 4193321 · Received October 22, 2014

    Report

    Report Number
    3005099803-2014-03451
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 24, 2014
    Report Date
    October 3, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED COMPLAINT OF CURRENT FAILURE. (B)(4) FOR THE REPORTED COMPLAINT OF LOOP EMBEDDED IN PATIENT'S TISSUE. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR EXTRA LARGE ROUND SNARE WAS USED IN THE LARGE INTESTINE DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GENERATOR WAS SET TO 20 FOR COAGULATION, 1 FOR CUT AND 1 FOR BLEND, HOWEVER, THE PHYSICIAN NOTED THAT NO CAUTERY WAS DELIVERED TO THE SNARE. THE GENERATOR WAS CHECK AND THE ACTIVE CORD REPLACED BUT THE PROBLEM STILL OCCURRED. THE SETTINGS WERE ADJUSTED UP TO COAGULATION 20, CUT 10, AND BLEND 1 BUT STILL NO CURRENT WAS BEING DELIVERED. THE PHYSICIAN REQUESTED THAT THE SNARE BE REMOVED BUT THE SNARE WAS STUCK ON THE POLYP TISSUE AND THEY WERE UNABLE TO REMOVE IT. THE SNARE WAS THEN EXTENDED SO THE SCOPE COULD BE REMOVED AND THE SNARE WIRE CUT AT THE END OF THE SCOPE. THE TECH WAS ABLE TO GRAB THE SNARE WIRE BUT DUE TO CONTRACTIONS IN THE COLON, THE SNARE WIRE WAS PULLED BACK INTO THE COLON. ONE SIDE OF THE SNARE WIRE WAS MANUALLY EXTRACTED FROM THE RECTUM USING FINGERS AND THE ENTIRE SNARE WIRE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. REPORTEDLY, THE PATIENT IS SCHEDULED FOR ANOTHER SURGERY TO REMOVE THE POLYP HOWEVER, THE DATE FOR THE PROCEDURE IS UNKNOWN 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
    673017 CAPTIVATOR? II SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00561291 15669658

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention