BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIFLEX¿

    MDR report key: 2921026 · Received January 17, 2013

    Report

    Report Number
    3005099803-2013-00012
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT PATIENT AGE IS UNKNOWN BUT IS OVER 18 YEARS. (B)(4) FOR THE REPORTED EVENT: SNARE FAILED TO TRANSMIT CURRENT. 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.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2013-00010, MANUFACTURER REPORT # 3005099803-2013-00011, AND MANUFACTURER REPORT # 3005099803-2013-00012 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE CAPTIFLEX MEDIUM OVAL SNARES WERE USED DURING A COLONOSCOPY WITH POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST SNARE FAILED TO TRANSMIT CURRENT. THE CAUTERY PIN WAS OBSERVED TO BE SECURELY ATTACHED TO THE HANDLE. NO VISIBLE DAMAGE TO THE DEVICE WAS NOTED. THE SAME ISSUE OCCURRED WITH ALL THREE SNARES. THE PROCEDURE WAS COMPLETED USING A FOURTH CAPTIFLEX MEDIUM OVAL SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE "FINE." 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

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2013-00010, MANUFACTURER REPORT # 3005099803-2013-00011, AND MANUFACTURER REPORT # 3005099803-2013-00012 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE CAPTIFLEX MEDIUM OVAL SNARES WERE USED DURING A COLONOSCOPY WITH POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST SNARE FAILED TO TRANSMIT CURRENT. THE CAUTERY PIN WAS OBSERVED TO BE SECURELY ATTACHED TO THE HANDLE. NO VISIBLE DAMAGE TO THE DEVICE WAS NOTED. THE SAME ISSUE OCCURRED WITH ALL THREE SNARES. THE PROCEDURE WAS COMPLETED USING A FOURTH CAPTIFLEX MEDIUM OVAL SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE "FINE." 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
    26145 CAPTIFLEX¿ MEDIUM OVAL - FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562401 0015447426

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR