BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIFLEX¿

    MDR report key: 3083200 · Received April 29, 2013

    Report

    Report Number
    3005099803-2013-03124
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED.(B)(4).ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. THEREFORE, A DEVICE EVALUATION HAS NOT BEEN PERFORMED AND THE REPORTED MALFUNCTION COULD NOT BE CONFIRMED. HOWEVER, THE REPORTED ISSUE CAN OCCUR DUE TO PROCEDURAL FACTORS SUCH AS TORTUOUS ANATOMY; THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT A CAPTIFLEX EXTRA SMALL OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE DEVICE WAS BEING ADVANCED THOUGH THE SCOPE, RESISTANCE WAS MET. THE DEVICE WAS REMOVED FROM THE ENDOSCOPE AND THE PHYSICIAN NOTED THAT THE DISTAL END OF THE CATHETER WAS TORN/SPLIT FOR 1-2 INCHES. IT WAS REPORTED THAT THE DEVICE WAS INSPECTED PRIOR TO THE PROCEDURE AND THERE WERE NO VISIBLE ISSUES, AND NO EXCESSIVE FORCE HAD BEEN APPLIED TO THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIFLEX SNARE. 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
    184919 CAPTIFLEX¿ EXTRA SMALL OVAL - FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562471

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR