BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPTIVATOR¿

    MDR report key: 2896409 · Received January 4, 2013

    Report

    Report Number
    3005099803-2012-06281
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    November 28, 2012
    Report Date
    December 11, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE COMPLAINT DEVICE FOUND A KINK IN THE CATHETER AS WELL AS THE WIRE. FUNCTIONAL ANALYSIS WAS PERFORMED AND THE UNIT PASSED THE RETROFLEX TEST AND WAS ABLE TO OPEN AND CLOSE SMOOTHLY. THIS FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE PERFORMANCE OF THE DEVICE. 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. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION AND DEVICE MANUFACTURED DATES ARE UNKNOWN. HOWEVER, THE DEVICE WAS NOT USED PAST ITS EXPIRATION DATE. 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 CAPTIVATOR MEDIUM OVAL SNARE WAS USED DURING A FLEXIBLE SIGMOIDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE SNARE LOOP WAS PLACED AROUND A POLYP, THE HANDLE WAS ACTUATED, HOWEVER, THE SNARE BECAME STIFF AND WOULD NOT CLOSE SMOOTHLY. THE SNARE LOOP CLOSED QUICKLY AND SHEARED OFF THE POLYP BEFORE CAUTERY COULD BE APPLIED. THE TARGET SITE BEGAN TO SLOWLY BLEED. THE PATIENT REMAINED IN THE HOSPITAL OVERNIGHT FOR OBSERVATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM OVAL SNARE WAS USED DURING A FLEXIBLE SIGMOIDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE SNARE LOOP WAS PLACED AROUND A POLYP, THE HANDLE WAS ACTUATED, HOWEVER, THE SNARE BECAME STIFF AND WOULD NOT CLOSE SMOOTHLY. THE SNARE LOOP CLOSED QUICKLY AND SHEARED OFF THE POLYP BEFORE CAUTERY COULD BE APPLIED. THE TARGET SITE BEGAN TO SLOWLY BLEED. THE PATIENT REMAINED IN THE HOSPITAL OVERNIGHT FOR OBSERVATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4760 CAPTIVATOR¿ MEDIUM OVAL - STIFF FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562321 15464110

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization