BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL

    MDR report key: 6112834 · Received November 18, 2016

    Report

    Report Number
    3005099803-2016-03510
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 28, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FGO
    UDI-DI
    08714729430223
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    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. 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 MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE COIL WITH THE DISTAL STOP AND BALL WELD WAS SEPARATED FROM THE DEVICE. A BURN MARK ON THE BLUE GREEN SHRINK WAS NOTED INDICATING USE OF LASER ON THE UNIT. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATES THAT THERE WAS AN EVIDENCE OF SCORCHING WHICH WAS MOST LIKELY CAUSED BY THE LASER DURING THE PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS "CAUSED BY OTHER DEVICE". 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. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL WAS USED IN THE URETER DURING A HOLMIUM LASER LITHOTRIPSY WITH URETEROPYELOSCOPY PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AFTER THE LASER WAS USED, THE COIL OF THE STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL WAS FOUND DETACHED INSIDE THE PATIENT. IT IS UNKNOWN IF THE LASER CAME IN CONTACT WITH THE STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL DEVICE. THE BROKEN PIECE WAS COMPLETELY REMOVED FROM THE PATIENT USING FORCEPS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL WAS USED IN THE URETER DURING A HOLMIUM LASER LITHOTRIPSY WITH URETEROPYELOSCOPY PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AFTER THE LASER WAS USED, THE COIL OF THE STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL WAS FOUND DETACHED INSIDE THE PATIENT. IT IS UNKNOWN IF THE LASER CAME IN CONTACT WITH THE STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL DEVICE. THE BROKEN PIECE WAS COMPLETELY REMOVED FROM THE PATIENT USING FORCEPS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765689 STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL DISLODGER, STONE, FLEXIBLE FGO BOSTON SCIENTIFIC - MARLBOROUGH M0063903200 D62506 08714729430223

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention