BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL

    MDR report key: 7144235 · Received December 22, 2017

    Report

    Report Number
    3005099803-2017-03820
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    November 29, 2017
    Report Date
    December 6, 2017
    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
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE BLUE SHEATH IS BUCKLED AND ACCORDIONED IN SEVERAL PLACES ALONG THE SHAFT. THE DISTAL END OF THE BLUE SHEATH IS TORN AND APPEARS HEAT DAMAGED. THE DISTAL SECTION OF THE BLUE/GREEN HEAT SHRINK IS ACCORDIONED. THE EXPOSED COIL WIRE IN THIS AREA APPEARS HEAT DAMAGED. REVIEW AND ANALYSIS OF THE DEVICE SHOWS EVIDENCE OF HEAT DAMAGE WHICH WAS MOST LIKELY CAUSED DURING THE URETEROSCOPY LITHOTRIPSY PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS "CAUSED BY OTHER DEVICE" SINCE THE INVESTIGATION INDICATES ANOTHER DEVICE/DRUG/SUBSEQUENT PROCEDURE CAUSED THE COMPLAINT EVENT. THE DEVICE HISTORY RECORD (DHR) REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED AND NO ANOMALY WAS FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4). LAKE REGION MEDICAL- (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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.

    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 KIDNEY, DURING A URETEROSCOPY WITH LITHOTRIPSY PROCEDURE. THE PROCEDURE WAS PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, IT WAS NOTICED THAT THE DEVICE WAS FRAGMENTED. ANOTHER URETEROSCOPY WAS PERFORMED AND A PIECE OF THE BLUE PLASTIC COVER WAS OBSERVED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DIFFERENT DEVICE. THERE IS NO CONFIRMATION IF THE PIECE OF THE BLUE PLASTIC COVER WAS RETRIEVED. 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 KIDNEY, DURING A URETEROSCOPY WITH LITHOTRIPSY PROCEDURE. THE PROCEDURE WAS PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, IT WAS NOTICED THAT THE DEVICE WAS FRAGMENTED. ANOTHER URETEROSCOPY WAS PERFORMED AND A PIECE OF THE BLUE PLASTIC COVER WAS OBSERVED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DIFFERENT DEVICE. THERE IS NO CONFIRMATION IF THE PIECE OF THE BLUE PLASTIC COVER WAS RETRIEVED. 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
    921459 STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL DISLODGER, STONE, FLEXIBLE FGO BOSTON SCIENTIFIC - MARLBOROUGH M0063903200 0003768063 08714729430223

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention