BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES

    MDR report key: 1961856 · Received January 14, 2011

    Report

    Report Number
    3005099803-2011-00136
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: SECOND SNARE WAS NOT SENT DOWN THE SCOPE. CORRECTION: PROCEDURE WAS COMPLETED WITH A COMPETITOR'S SNARE. ADDITIONAL INFORMATION: CAUTERY PIN DID NOT DETACH, BUT RATHER WAS BENT. VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THE CAUTERY PIN BENT. DURING FUNCTIONAL EVALUATION, THE LOOP EXTENDED AND RETRACTED WITHIN SPECIFICATION. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE CAUTERY PIN WAS BENT; THE COMPLAINT WAS CONFIRMED. DURING THE MANUFACTURING PROCESS, THE CAUTERY PIN IS ATTACHED TO THE HANDLE VIA A TORQUE SCREWDRIVER OPERATION THAT CANNOT BE THE CAUSE OF THIS FAILURE AS IT CONTACTS THE BASE OF THE CAUTERY PIN, NOT THE HEAD. ADDITIONALLY, UNITS ARE SUBMITTED TO A FINAL INSPECTION TO ASSURE INTEGRITY OF THE CONNECTOR, DURING WHICH A VINYL CAP PROTECTOR IS PLACED. THE VINYL CAP COULD NOT BE FITTED AT ALL OVER THE CONNECTOR DUE TO THE DEFORMATION OF THE RETURNED DEVICE. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-00135 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CAPTIVATOR POLYPECTOMY SNARES WERE USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE FIRST SNARE WAS ADVANCED THROUGH THE SCOPE AND INTO THE PATIENT. WHEN THE ACTIVE CORD WAS ABOUT TO BE CONNECTED, IT WAS NOTED THAT THE ACTIVE CORD CONNECTOR OF THE SNARE WAS DAMAGED. THIS SNARE WAS REMOVED FROM THE SCOPE. A SECOND CAPTIVATOR POLYPECTOMY SNARE WAS EXAMINED AND IT WAS NOTED THAT THE ACTIVE CORD CONNECTOR OF THIS DEVICE WAS DAMAGED AS WELL. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR'S 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 GOOD. FOLLOW-UP INFORMATION REGARDING THIS EVENT REVEALED THAT THE SECOND SNARE WAS NEVER SENT DOWN THE SCOPE AND THAT THE PROCEDURE WAS COMPLETED WITH A SNARE FROM A DIFFERENT MANUFACTURER. ADDITIONALLY, THE CAUTERY PIN DID NOT DETACH AS PREVIOUSLY REPORTED, BUT RATHER WAS BENT. BASED ON THE LATTER, THIS IS NO LONGER A REPORTABLE EVENT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-00135 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CAPTIVATOR POLYPECTOMY SNARES WERE USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE FIRST SNARE WAS ADVANCED THROUGH THE SCOPE AND INTO THE PATIENT. WHEN THE ACTIVE CORD WAS ABOUT TO BE CONNECTED, IT WAS NOTED THAT THE ACTIVE CORD CONNECTOR OF THE SNARE WAS DAMAGED. THIS SNARE WAS REMOVED FROM THE SCOPE. A SECOND CAPTIVATOR POLYPECTOMY SNARE WAS EXAMINED AND SENT DOWN THE SCOPE, WHEN IT WAS NOTED THAT THE ACTIVE CORD CONNECTOR OF THIS DEVICE WAS DAMAGED AS WELL. THE PROCEDURE WAS COMPLETED WITH A THIRD CAPTIVATOR POLYPECTOMY 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 GOOD. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE NATURE OF THE DAMAGE TO THE DEVICE AND THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. BECAUSE IT COULD NOT BE CONFIRMED WHETHER THE CAUTERY PIN DETACHED, THIS HAS BEEN DEEMED A REPORTABLE EVENT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA M00562341 0013471600

    Patients

    Seq Age Sex Outcome Treatment
    1