BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS ULTRA

    MDR report key: 8739452 · Received June 27, 2019

    Report

    Report Number
    3005099803-2019-03228
    Event Type
    Malfunction
    Date Received
    June 27, 2019
    Date of Event
    May 31, 2019
    Report Date
    August 21, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAD
    UDI-DI
    08714729124306
    PMA / PMN Number
    K010002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. BLOCK F10; H6: PROBLEM CODE 1069 CAPTURES THE REPORTABLE EVENT OF STENT SHAFT BREAK. BLOCK G5: PREMARKET/510(K)# - K010002. BLOCK H10: A POLARIS ULTRA STENT WAS RETURNED FOR ANALYSIS. A VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE SHAFT OF THE STENT WAS DETACHED. BASED ON THE PRODUCT ANALYSIS, THE ISSUE WAS NOTED DURING THE PROCEDURE, MOREOVER, NO DEFECTS WERE REPORTED BY THE CUSTOMER DURING THE UNPACKING AND PREPARATION. THE REPORTED ISSUES OBSERVED IN THE PROVIDED IMAGES THAT COULD HAVE BEEN GENERATED BY USER, ALSO INTERACTION WITH OTHER DEVICES MIGHT HAVE IMPACTED THE INTEGRITY OF THE DEVICE DURING THE PROCEDURE. THEREFORE, "ADVERSE EVENT RELATED TO PROCEDURE" IS SELECTED AS THE MOST PROBABLE ROOT CAUSE FOR THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS AT THE TIME OF RELEASE FOR DISTRIBUTION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA STENT WAS USED DURING A KIDNEY STONES REMOVAL SURGERY PROCEDURE IN THE KIDNEY, PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THE STENT WAS BROKEN ALONG THE SHAFT. THERE WAS NO SERIOUS INJURY, NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. (B)(4). PREMARKET/510(K)# - K010002. 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 POLARIS ULTRA STENT WAS USED DURING A KIDNEY STONES REMOVAL SURGERY PROCEDURE IN THE KIDNEY, PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THE STENT WAS BROKEN ALONG THE SHAFT. THERE WAS NO SERIOUS INJURY, NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535194 POLARIS ULTRA STENT, URETERAL FAD BOSTON SCIENTIFIC CORPORATION M0061921220 0022802039 08714729124306

    Patients

    Seq Age Sex Outcome Treatment
    1