BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES

    MDR report key: 2080010 · Received May 6, 2011

    Report

    Report Number
    3005099803-2011-01557
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION AND DEVICE MANUFACTURED DATES ARE UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. A SHIP HISTORY WAS PERFORMED AND IDENTIFIED THE THREE MOST PROBABLE LOTS SHIPPED TO THIS ACCOUNT: 13619121, 13557189 & 13608547. A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOTS. A LABELING REVIEW WAS PERFORMED AND NO ANOMALY WAS FOUND. THE MOST PROBABLE ROOT CAUSE OF THIS EVENT IS OPERATIONAL CONTEXT; IT IS LIKELY THAT ANATOMICAL OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE LIMITED THE DEVICE PERFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION STANDARD OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE NON-BSC GENERATOR USED DURING THE PROCEDURE WAS TESTED BEFOREHAND AND WORKED PROPERLY. DURING THE PROCEDURE, IT WAS REPORTED TO BE VERY CHALLENGING TO LOOP THE SNARE AROUND THE TARGET POLYP AS IT WAS VERY LARGE. THE POLYP WAS SUCCESSFULLY LOOPED, BUT IT WAS REPORTED THAT NO SIGNS OF CAUTERY WERE OBSERVED WHEN POWER WAS APPLIED AND THE SNARE WAS UNABLE TO CUT THROUGH THE POLYP. IT WAS THEN FOUND THAT THE SNARE WAS EMBEDDED IN THE PATIENT TISSUE, SO THE HANDLE WAS CUT OFF AND A SECOND SENSATION SNARE WAS INTRODUCED. THE POLYP WAS REMOVED IN A PIECEMEAL FASHION WITH THIS SNARE, BUT THE PHYSICIAN WAS UNABLE TO REMOVE THE ENTIRE POLYP BECAUSE THE FIRST SNARE IMPEDED ATTEMPTS TO RESECT THE TISSUE IN WHICH IT WAS LODGED. THE SECOND SNARE AND THE SCOPE WERE REMOVED FROM THE PATIENT, WHO WAS SENT FOR SURGERY TO REMOVE THE POLYP AND SNARE. THE ACCOUNT ALLEGED NO MALFUNCTION OF THE SECOND SNARE AND CONFIRMED THAT SIGNS OF SUCCESSFUL CAUTERY WERE VISUALIZED DURING ITS USE. 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
    1 PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA M00562672

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention