BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES

    MDR report key: 2002760 · Received February 28, 2011

    Report

    Report Number
    3005099803-2011-00562
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6):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 FOUND A FOREIGN PIECE OF METAL WEDGED BETWEEN THE PRONGS OF THE CAUTERY PIN. NO OTHER DAMAGE WAS FOUND, AND THE LOOP EXTENDED AND RETRACTED ACCORDING TO SPECIFICATION. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE DEVICE WAS "UNABLE TO APPLY ELECTRIC CURRENT"; THE COMPLAINT WAS CONFIRMED. THIS MAY BE A SUPPLIER MANUFACTURING ISSUE, AND A SUPPLIER CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR POLYPECTOMY SNARE WAS USED DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE SNARE WAS UNABLE TO APPLY CAUTERY. THE CAUTERY PIN WAS REPORTED TO BE SECURELY ATTACHED TO THE HANDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR POLYPECTOMY SNARE WAS USED DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE SNARE WAS UNABLE TO APPLY CAUTERY. THE CAUTERY PIN WAS REPORTED TO BE SECURELY ATTACHED TO THE HANDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA M00562451 0013395327

    Patients

    Seq Age Sex Outcome Treatment
    1