BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTOSNARE

    MDR report key: 1840609 · Received September 22, 2010

    Report

    Report Number
    3005099803-2010-04000
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    July 7, 2010
    Report Date
    August 30, 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. A ROOT CAUSE FOR THE DETACHMENT AND LOOP EXTENSION ISSUE COULD NOT BE DETERMINED.A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A LABELING REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2010-03999 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ROTATABLE OVAL SNARES WERE USED DURING A POLYPECTOMY PROCEDURE ON (B)(6), 2010. ACCORDING TO THE COMPLAINT, THE SNARE LOOP COULD NOT COME OUT FROM THE SHEATH BECAUSE OF RESISTANCE FELT WHEN ACTUATING THE HANDLE (THIS DEVICE THE SUBJECT OF MANUFACTURER REPORT # 3005099803-2010-04000). THERE WERE NO REPORTED KINKS OR BENDS ON THE CATHETER SHEATH, AND THE SCOPE WAS NOT IN A TORTUOUS POSITION. AFTERWARDS, THE PHYSICIAN TESTED ANOTHER SNARE OUTSIDE OF THE PATIENT, BUT IT WAS NOTED THAT THE OUTER SHEATH WAS TORN ABOUT 15CM FROM THE HANDLE (THIS DEVICE THE SUBJECT OF MANUFACTURER REPORT # 3005099803-2010-03999). ON (B)(6), 2010, AN INITIAL REVIEW OF THE RETURNED DEVICE ASSOCIATED WITH MANUFACTURER REPORT # 3005099803-2010-04000 REVEALED THAT THE WORKING LENGTH HAD DETACHED FROM HANDLE, MAKING THIS A REPORTABLE EVENT. THE ORIGINAL PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO COMPLICATIONS TO THE PATIENT. THE PATIENT'S CONDITION HAD BEEN DESCRIBED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTOSNARE SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA M00561831 0013150181

    Patients

    Seq Age Sex Outcome Treatment
    1