BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE SNARE

    MDR report key: 3915511 · Received July 7, 2014

    Report

    Report Number
    3005099803-2014-02452
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    May 26, 2014
    Report Date
    June 12, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K992477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: WIRE BROKEN. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT 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.

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE CATHETER WAS KINKED. 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 DEVICE HAS THE FLARE DETACHED PREVENTING DEVICE ACTUATION. 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 SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2014-02452, AND MANUFACTURER REPORT # 3005099803-2014-02453 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ROTATABLE SMALL OVAL SNARES WERE USED DURING A COLONIC POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO EXTEND THE FIRST SNARE HOWEVER, RESISTANCE WAS FELT. WHEN PRESSURE WAS APPLIED, THE SNARE WIRE FELT CUT OFF AND COULD NOT BE EXTENDED. IT WAS REPORTED THAT THE WIRE WAS BROKEN BUT, WHERE THE WIRE BROKE IS UNKNOWN. THE SECOND ROTATABLE SNARE WAS USED BUT THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2014-02452, AND MANUFACTURER REPORT # 3005099803-2014-02453 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ROTATABLE SMALL OVAL SNARES WERE USED DURING A COLONIC POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO EXTEND THE FIRST SNARE HOWEVER, RESISTANCE WAS FELT. WHEN PRESSURE WAS APPLIED, THE SNARE WIRE FELT CUT OFF AND COULD NOT BE EXTENDED. IT WAS REPORTED THAT THE WIRE WAS BROKEN BUT, WHERE THE WIRE BROKE IS UNKNOWN. THE SECOND ROTATABLE SNARE WAS USED BUT THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394611 ROTATABLE SNARE SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00561821 0016801072

    Patients

    Seq Age Sex Outcome Treatment
    1