BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL

    MDR report key: 2021815 · Received March 17, 2011

    Report

    Report Number
    3005099803-2011-00763
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FGO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: (B)(4) URETEROSCOPE. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND KINKING AND PEELING ON THE BLUE/GREEN HEAT SHRINK. IT WAS ALSO CONFIRMED THAT THE SHEATH WAS DAMAGED (TORN/SPLIT ). RESISTANCE WAS FELT WHILE OPERATING THE DEVICE, WHICH WOULD NOT FULLY CLOSE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT; SHEATH DAMAGE. THE MOST PROBABLE ROOT CAUSE OF THE EVENT IS CAUSED BY OTHER DEVICE AS IT IS POSSIBLE THAT THE DEVICE WAS DAMAGED BY THE URETEROSCOPE DURING USE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. (B)(4).

    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 URINARY STONE REMOVAL PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN MET RESISTANCE WHILE INSERTING THE DEVICE INTO THE URETEROSCOPE. THE DEVICE WAS THEN REMOVED FROM THE SCOPE AND INSPECTED. ALLEGEDLY IT LOOKED AS THOUGH THE STONE CONE PART OF THE DEVICE HAD A HANGNAIL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. REPORTEDLY THE DEVICE WAS INSPECTED/TESTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. 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 URINARY STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN MET RESISTANCE WHILE INSERTING THE DEVICE INTO THE URETEROSCOPE. THE DEVICE WAS THEN REMOVED FROM THE SCOPE AND INSPECTED. ALLEGEDLY IT LOOKED AS THOUGH THE STONE CONE PART OF THE DEVICE HAD A HANGNAIL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. REPORTEDLY THE DEVICE WAS INSPECTED/TESTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. 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
    1 STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL DISLODGER, STONE, FLEXIBLE FGO BOSTON SCIENTIFIC - MARLBOROUGH M0063903100 0000763861

    Patients

    Seq Age Sex Outcome Treatment
    1