BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTATABLE SNARE

    MDR report key: 2223853 · Received August 26, 2011

    Report

    Report Number
    3005099803-2011-02933
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FDI
    PMA / PMN Number
    K992477
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED NO ISSUES, AND THE UNIT EXTENDED AND RETRACTED ACCORDING TO SPECIFICATIONS DURING FUNCTIONAL TESTING. A RESISTANCE TEST WAS PERFORMED AND THE UNIT PASSED (DEVICE READ AT 11.70 OHMS). THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE SNARE FAILED TO DELIVER ENERGY; THE COMPLAINT WAS NOT CONFIRMED. 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.

    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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE OVAL SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE SNARE FAILED TO DELIVER ENERGY AND, AS A RESULT, THE TARGET POLYP WAS REMOVED WITHOUT CAUTERY. SINCE THE PATIENT WAS DIABETIC THERE WAS CONCERN ABOUT SUBSEQUENT BLEEDING, BUT IT WAS REPORTED THAT AMOUNT OF BLEEDING WAS NOT EXCESSIVE. THE BLEED WAS TREATED BY CLIPPING WITH NO FURTHER ISSUES. 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 ROTATABLE OVAL SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE SNARE FAILED TO DELIVER ENERGY AND, AS A RESULT, THE TARGET POLYP WAS REMOVED WITHOUT CAUTERY. SINCE THE PATIENT WAS DIABETIC THERE WAS CONCERN ABOUT SUBSEQUENT BLEEDING, BUT IT WAS REPORTED THAT AMOUNT OF BLEEDING WAS NOT EXCESSIVE. THE BLEED WAS TREATED BY CLIPPING WITH NO FURTHER ISSUES. 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 ROTATABLE SNARE SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA M00561821 14305432

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention