BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTOSNARE

    MDR report key: 1840511 · Received September 21, 2010

    Report

    Report Number
    3005099803-2010-04002
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    July 5, 2010
    Report Date
    August 31, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FDI
    PMA / PMN Number
    K992477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS OF THE RETURNED DEVICE CONFIRMED THAT THE SNARE LOOP COULD NOT EXTEND. FURTHER EXAMINATION REVEALED A PREVIOUSLY UNKNOWN FAILURE MODE; THE CATHETER SHEATH HAD DETACHED FROM THE HANDLE MECHANISM, WHICH PREVENTED THE SNARE FROM RETRACTING AND EXTENDING AS INTENDED. SINCE THE COMPLAINANT INDICATED THAT THEY DID NOT UNCOIL THE DEVICE PRIOR TO USE, THE POTENTIAL ROOT CAUSE FOR THE CATHETER DETACHMENT AND LOOP EXTENSION ISSUE HAS BEEN LABELED AS USER/USE ERROR. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE OVAL SNARE WAS USED DURING AN ENDOSCOPIC MUCOSAL RESECTION PROCEDURE ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE LOOP OF THE SNARE COULD NOT BE EXTENDED. THERE WERE NO REPORTED BENDS OR KINKS ALONG THE WORKING LENGTH OF THE CATHETER, NOR WERE THERE ANY ISSUES WITH HOW THE HANDLE FUNCTIONED. THE COMPLAINANT, HOWEVER, ADDED THAT THE DEVICE WAS NOT COMPLETELY UNCOILED PRIOR TO USE. THE PHYSICIAN WAS ABLE TO USE ANOTHER ROTATABLE OVAL SNARE TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS- THE CATHETER SHEATH DETACHED FROM HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTOSNARE SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA M00561831 12883791

    Patients

    Seq Age Sex Outcome Treatment
    1