BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL

    MDR report key: 2222570 · Received August 25, 2011

    Report

    Report Number
    3005099803-2011-02865
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED STONE CONE RETRIEVAL COIL REVEALED THE DISTAL END OF THE DEVICE, FROM THE CENTER OF THE CONE TO THE DISTAL BALL, WAS MISSING. IT WAS ALSO NOTED THAT THE DEVICE DID NOT OPEN OR CLOSE. PER ADDITIONAL INFORMATION RECEIVED, THE TIP OF THE DEVICE HAD BEEN INADVERTENTLY HIT BY A LASER DURING THE PROCEDURE, CAUSING IT TO BECOME DETACHED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND CONFIRMED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS CAUSED BY OTHER DEVICE.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION: NOT YET RECEIVED, NOT YET EVALUATED. 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 MEDWATCH WILL BE FILED. AT THIS TIME WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE STONE RETRIEVAL COIL WAS USED DURING A URETEROSCOPY PROCEDURE. THE PATIENT WAS REPORTED TO BE A MALE OVER 18 YEARS OF AGE. (PATIENT DATE OF BIRTH, AGE AT TIME OF EVENT, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE TIP OF THE DEVICE ABOVE THE ACTUAL CONE/COIL HAD BEEN INADVERTENTLY HIT BY THE LASER DURING THE PROCEDURE AND BECAME DETACHED. THIS WAS NOTICED WHEN THE COIL WAS BEING WITHDRAWN FROM THE PATIENT. THE DOCTOR STATED HE WENT IMMEDIATELY BACK IN WITH SOME BIOPSY FORCEPS THROUGH THE SCOPE AND RETRIEVED THE TIP WITH NO FURTHER COMPLICATIONS OR ISSUES. THERE WAS NO PATIENT INJURY. THERE WERE NO COMPLICATIONS NOTED AND THE PATIENT CONDITION IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE STONE RETRIEVAL COIL WAS USED DURING A URETEROSCOPY PROCEDURE. THE PATIENT WAS REPORTED TO BE A MALE OVER (B)(6). (PATIENT DATE OF BIRTH, AGE AT TIME OF EVENT, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE TIP OF THE DEVICE ABOVE THE ACTUAL CONE/COIL HAD BEEN INADVERTENTLY HIT BY THE LASER DURING THE PROCEDURE AND BECAME DETACHED. THIS WAS NOTICED WHEN THE COIL WAS BEING WITHDRAWN FROM THE PATIENT. THE DOCTOR STATED HE WENT IMMEDIATELY BACK IN WITH SOME BIOPSY FORCEPS THROUGH THE SCOPE AND RETRIEVED THE TIP WITH NO FURTHER COMPLICATIONS OR ISSUES. THERE WAS NO PATIENT INJURY. THERE WERE NO COMPLICATIONS NOTED AND THE PATIENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL DISLODGER, STONE, FLEXIBLE FGO BOSTON SCIENTIFIC - SPENCER M0063903100 0000826415

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention