BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFILE¿

    MDR report key: 2226949 · Received August 30, 2011

    Report

    Report Number
    3005099803-2011-02981
    Event Type
    Malfunction
    Date Received
    August 30, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE HANDLE CANNULA WAS BENT, AND A KINK WAS FOUND IN THE PROXIMAL SECTION OF THE WORKING LENGTH. THE CONDITION OF THE RETURNED DEVICE RENDERED FUNCTIONAL TESTING IMPOSSIBLE. THE COMPLAINT WAS CONFIRMED; THE BENT HANDLE CANNULA PREVENTED DEVICE ACTUATION. MANIPULATION OF THE DEVICE DURING THE PROCEDURE LIKELY CAUSED THE KINK NEAR THE HANDLE, CAUSING RESISTANCE DURING SUBSEQUENT ATTEMPTS TO ACTUATE THE DEVICE. THIS RESISTANCE CAN CAUSE THE HANDLE CANNULA TO BEND; THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THE DEFECTS IDENTIFIED IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. CLARIFICATION OF THE COMPLAINANT'S STATEMENT THAT "THERE IS A WIRE STICKING OUT NEAR THE HANDLE" WAS NEVER RECEIVED; THEREFORE, THE PRIORITY OF THIS COMPLAINT WAS MAINTAINED AS "MALFUNCTION." HOWEVER, EVALUATION OF THE RETURNED DEVICE FOUND A BENT HANDLE CANNULA AND ONE KINK IN THE WORKING LENGTH; NO OTHER ISSUES WERE NOTED. THIS IS NO LONGER CONSIDERED A REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE WIDE OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE (WITH POLYPECTOMY) PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN MADE SEVERAL ATTEMPTS BUT WAS UNABLE TO EXTEND THE SNARE LOOP. THE PHYSICIAN SUSPECTED THE ISSUE TO HAVE BEEN CAUSED BY THE SCOPE POSITION AND REMOVED THE SCOPE FROM THE PATIENT; HOWEVER, THE SNARE LOOP STILL WOULD NOT EXTEND. IT WAS REPORTED THAT THE HANDLE COULD BE ACTUATED BUT THE SNARE WOULD NOT MOVE, AND A WIRE WAS NOTED TO BE "STICKING OUT NEAR THE HANDLE." THIS WIRE WAS NOT THE SNARE WIRE ITSELF, BUT FURTHER DETAILS REGARDING THE CONDITION OF THE DEVICE ARE UNAVAILABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROFILE WIDE OVAL 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. DUE TO THE AMBIGUITY OF THE EVENT DESCRIPTION ("WIRE STICKING OUT NEAR THE HANDLE"), THIS WILL BE CONSIDERED A REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE WIDE OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE (WITH POLYPECTOMY) PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN MADE SEVERAL ATTEMPTS BUT WAS UNABLE TO EXTEND THE SNARE LOOP. THE PHYSICIAN SUSPECTED THE ISSUE TO HAVE BEEN CAUSED BY THE SCOPE POSITION AND REMOVED THE SCOPE FROM THE PATIENT; HOWEVER, THE SNARE LOOP STILL WOULD NOT EXTEND. IT WAS REPORTED THAT THE HANDLE COULD BE ACTUATED BUT THE SNARE WOULD NOT MOVE, AND A WIRE WAS NOTED TO BE "STICKING OUT NEAR THE HANDLE." THIS WIRE WAS NOT THE SNARE WIRE ITSELF, BUT FURTHER DETAILS REGARDING THE CONDITION OF THE DEVICE ARE UNAVAILABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROFILE WIDE OVAL 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. DUE TO THE AMBIGUITY OF THE EVENT DESCRIPTION ("WIRE STICKING OUT NEAR THE HANDLE"), THIS WILL BE CONSIDERED A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFILE¿ SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA M00562571 14397046

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR