BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL

    MDR report key: 5110339 · Received September 29, 2015

    Report

    Report Number
    3005099803-2015-02748
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Report Date
    September 3, 2015
    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

    THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. 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 WHITE HEAT SHRINK WAS ACCORDIONED AND STRETCHED AT THE PROXIMAL END. THE BLUE/GREEN HEAT SHRINK ON THE CONE IS PEELING. FUNCTIONAL EVALUATION WAS PERFORMED AND THE DEVICE WAS STUCK HALFWAY AND WOULD NOT OPEN NOR CLOSE. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE COMPLAINT WAS CONFIRMED. SINCE THE COMPLAINT IS ASSOCIATED WITH A PRODUCT WHICH MET SPECIFICATIONS BUT MOST LIKELY ENCOUNTERED ANATOMICAL OR PROCEDURAL FACTORS WHICH LIMITED ITS PERFORMANCE, THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS OPERATIONAL CONTEXT. 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.

    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 LITHOTRIPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, WHEN THE DEVICE WAS REMOVED FROM THE PATIENT AFTER THE PROCEDURE, IT WAS OBSERVED THAT THE GREEN/BLUE COATING OF THE STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL WAS "PEELED/ UNTWISTED". THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. THE PHYSICIAN STATED THAT DURING LITHOTRIPSY, THE PROBE OF LITHOTRIPSY SYSTEM MIGHT HAVE HAD CONTACT WITH STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL AND CAUSED THE DAMAGE, BUT IS NOT SURE. 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 IN THE URETER DURING A LITHOTRIPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, WHEN THE DEVICE WAS REMOVED FROM THE PATIENT AFTER THE PROCEDURE, IT WAS OBSERVED THAT THE GREEN/BLUE COATING OF THE STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL WAS "PEELED/ UNTWISTED". THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. THE PHYSICIAN STATED THAT DURING LITHOTRIPSY, THE PROBE OF LITHOTRIPSY SYSTEM MIGHT HAVE HAD CONTACT WITH STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL AND CAUSED THE DAMAGE, BUT IS NOT SURE. 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
    641903 STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL DISLODGER, STONE, FLEXIBLE FGO BOSTON SCIENTIFIC - MARLBOROUGH M0063903200 D02491

    Patients

    Seq Age Sex Outcome Treatment
    1