BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE SNARE

    MDR report key: 4152696 · Received October 8, 2014

    Report

    Report Number
    3005099803-2014-03357
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 18, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K992477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. REPORTED EVENT: WIRE BROKEN. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, 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 MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE FLARE WAS DETACHED AND CATHETER WAS SLIGHTLY KINKED. EVIDENCE OF THE FLARE MANUFACTURING PROCESS WAS PRESENT ON THE CATHETER. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE FLARE DETACHMENT. THE COMPLAINT WAS CONFIRMED; THE WIRE WAS FOUND INTACT, INSTEAD THE FLARE WAS DETACHED WHICH PREVENTED THE SNARE FROM BEING ACTUATED. ADDITIONALLY, THE CATHETER IS SLIGHTLY KINKED. THE REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILED TO INDICATE THE ROOT CAUSE OF THIS COMPLAINT. 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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO ROTATABLE MEDIUM OVAL MEDIUM SNARE USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2014-03357 ADDRESSES THE FIRST DEVICE, WHILE MANUFACTURER REPORT # 3005099803-2014-03358 REFERENCES THE SECOND DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ROTATABLE MEDIUM OVAL SNARES WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TWO ROTATABLE SNARES FAILED TO EXTEND. THE PHYSICIAN REPORTED THAT SOMETHING WAS BROKEN WITHIN THE DEVICES BUT THEY WERE UNSURE WHAT. A THIRD ROTATABLE SNARE WAS USED TO 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 FINE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO ROTATABLE MEDIUM OVAL MEDIUM SNARE USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2014-03357 ADDRESSES THE FIRST DEVICE, WHILE MANUFACTURER REPORT # 3005099803-2014-03358 REFERENCES THE SECOND DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ROTATABLE MEDIUM OVAL SNARES WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TWO ROTATABLE SNARES FAILED TO EXTEND. THE PHYSICIAN REPORTED THAT SOMETHING WAS BROKEN WITHIN THE DEVICES BUT THEY WERE UNSURE WHAT. A THIRD ROTATABLE SNARE WAS USED TO 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630893 ROTATABLE SNARE SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00561831 17081055

    Patients

    Seq Age Sex Outcome Treatment
    1