BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL

    MDR report key: 5959181 · Received September 18, 2016

    Report

    Report Number
    3005099803-2016-02629
    Event Type
    Injury
    Date Received
    September 18, 2016
    Report Date
    August 23, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FGO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. (B)(6). MEDWATCH# 5063754 .THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND THAT RETRIEVAL COIL WAS DETACHED/ SEPARATED AND ONLY APPROXIMATELY 5.5 CM OF THE DISTAL END WAS RETURNED. THE RETURNED PIECE IS THE DISTAL END OF THE COIL INCLUDING THE DISTAL STOP AND BALL WELD. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE DAMAGE WAS CAUSED BY ENCOUNTERED ANATOMICAL OR PROCEDURAL FACTORS WHICH LIMITS ITS PERFORMANCE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS "OPERATIONAL CONTEXT". 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 DURING A CYSTOURETHROSCOPY AND URETEROSCOPY (URS) WITH LASER LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2015, AT AN UNKNOWN HOSPITAL. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DISTAL PART OF THE DEVICE DETACHED IN THE PATIENT'S RIGHT URETER. THE DETACHMENT WAS NOT INITIALLY DISCOVERED, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. APPROXIMATELY 2 WEEKS POST-PROCEDURE, THE PATIENT STATED THAT "AN UMBRELLA LIKE DEVICE WHICH APPEARED TO BE MADE OF CELLOPHANE PASSED THROUGH HIS URETHRA". CT SCAN REVEALED THAT A FOREIGN BODY WAS NOTED TO BE IN THE RIGHT URETER. THE FOREIGN BODY WAS UNABLE TO BE REMOVED URETEROSCOPICALLY, THUS SURGICAL INTERVENTION WAS REQUIRED. IT WAS NOT DOCUMENTED THAT THE DEVICE CAME INTO CONTACT WITH THE LASER DURING THE PROCEDURE, BUT ACCORDING TO THE COMPLAINANT THAT IS THE ASSUMPTION. ON (B)(6) 2016, AT (B)(6) MC, DURING A RIGHT ANTEGRADE URETEROSCOPY WITH STENT PLACEMENT PROCEDURE, TWO MILDLY ENCRUSTED FRAGMENTS OF STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL DEVICE WERE 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL WAS USED DURING A CYSTOURETHROSCOPY AND URETEROSCOPY (URS) WITH LASER LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2015, AT AN UNKNOWN HOSPITAL. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DISTAL PART OF THE DEVICE DETACHED IN THE PATIENTS RIGHT URETER. THE DETACHMENT WAS NOT INITIALLY DISCOVERED, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. APPROXIMATELY 2 WEEKS POST-PROCEDURE, THE PATIENT STATED THAT "AN UMBRELLA LIKE DEVICE WHICH APPEARED TO BE MADE OF CELLOPHANE PASSED THROUGH HIS URETHRA." CT SCAN REVEALED THAT A FOREIGN BODY WAS NOTED TO BE IN THE RIGHT URETER. THE FOREIGN BODY WAS UNABLE TO BE REMOVED URETEROSCOPICALLY, THUS SURGICAL INTERVENTION WAS REQUIRED. IT WAS NOT DOCUMENTED THAT THE DEVICE CAME INTO CONTACT WITH THE LASER DURING THE PROCEDURE, BUT ACCORDING TO THE COMPLAINANT THAT IS THE ASSUMPTION. ON (B)(6) 2016, AT RICHMOND VAMC, DURING A RIGHT ANTEGRADE URETEROSCOPY WITH STENT PLACEMENT PROCEDURE, TWO MILDLY ENCRUSTED FRAGMENTS OF STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL DEVICE WERE 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610515 STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL DISLODGER, STONE, FLEXIBLE FGO BOSTON SCIENTIFIC - MARLBOROUGH M0063903100

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R