BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE SNARE

    MDR report key: 2973911 · Received February 22, 2013

    Report

    Report Number
    3005099803-2013-01040
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    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

    (B)(4) FOR THE REPORTED EVENT: SHEATH DETACHED NEAR DEVICE HANDLE. 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 COMPLAINT DEVICE FOUND THE FLARE TO BE DETACHED FROM THE HANDLE, AND IT WAS ALSO NOTED THAT THE WIRE AND CATHETER WERE KINKED NEAR THE HANDLE. A FUNCTIONAL EVALUATION OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED DUE TO THE FLARE DETACHMENT. THE COMPLAINT WAS CONFIRMED. MANIPULATION OF THE DEVICE DURING THE PROCEDURE LIKELY PRODUCED THE KINKS FOUND, WHICH WOULD CREATE RESISTANCE DURING SUBSEQUENT ATTEMPTS TO ACTUATE THE DEVICE. ACTUATION AGAINST THIS RESISTANCE CAN ULTIMATELY CAUSE THE FLARE TO DETACH, WHICH WOULD PREVENT LOOP EXTENSION. THE MOST PROBABLE ROOT CAUSE OF THE DEFECTS IDENTIFIED IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 4, 2013 THAT A ROTATABLE MEDIUM OVAL SNARE WAS USED DURING A REMOVAL OF A STENT PROCEDURE IN THE COMMON BILE DUCT (CBD) ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE WOULD NOT EXTEND FROM THE SHEATH AS THE SHEATH WAS DETACHED AT THE HANDLE. THE DEVICE WAS REMOVED FROM SERVICE AND ANOTHER ROTATABLE MEDIUM OVAL 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT A ROTATABLE MEDIUM OVAL SNARE WAS USED DURING A REMOVAL OF A STENT PROCEDURE IN THE COMMON BILE DUCT (CBD) ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE WOULD NOT EXTEND FROM THE SHEATH AS THE SHEATH WAS DETACHED AT THE HANDLE. THE DEVICE WAS REMOVED FROM SERVICE AND ANOTHER ROTATABLE MEDIUM OVAL 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78079 ROTATABLE SNARE MEDIUM OVAL FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00561831 15567193

    Patients

    Seq Age Sex Outcome Treatment
    1