BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE SNARE

    MDR report key: 3850916 · Received June 5, 2014

    Report

    Report Number
    3005099803-2014-02122
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 14, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K992477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE FLARE WAS DETACHED FROM THE CATHETER, AND THE CATHETER HAS MARKS FROM THE FLARE PROCESS PERFORMED DURING MANUFACTURING. FUNCTIONAL EVALUATION COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE COMPLAINT WAS CONFIRMED; THE FLARE WAS DETACHED WHICH DOES NOT ALLOW THE DEVICE TO BE ACTUATED. HOWEVER, REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILED TO INDICATE A ROOT CAUSE OR PROBABLE ROOT CAUSE FOR THIS EVENT. THERE IS AN INVESTIGATION IN PLACE TO ADDRESS THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF CATHETER DETACHED. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT YET BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2014-02123, AND MANUFACTURER REPORT # 3005099803-2014-02122 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ROTATABLE SMALL OVAL SNARES WERE OPENED DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN INTENDED TO USE THE FIRST SNARE TO REMOVE A PEN FROM THE PATIENT¿S STOMACH. HOWEVER, DURING PREPARATION, THE SHEATH DETACHED AND THE SNARE WAS UNABLE TO EXTEND. A SECOND DEVICE WAS PREPARED WHEN THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A THIRD ROTATABLE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT¿S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE ¿GOOD.¿

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2014-02123, AND MANUFACTURER REPORT # 3005099803-2014-02122 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ROTATABLE SMALL OVAL SNARES WERE OPENED DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN INTENDED TO USE THE FIRST SNARE TO REMOVE A PEN FROM THE PATIENT'S STOMACH. HOWEVER, DURING PREPARATION, THE SHEATH DETACHED AND THE SNARE WAS UNABLE TO EXTEND. A SECOND DEVICE WAS PREPARED WHEN THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A THIRD ROTATABLE SNARE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329605 ROTATABLE SNARE SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00561821 0016648473

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR