BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVATOR II

    MDR report key: 10627178 · Received October 5, 2020

    Report

    Report Number
    3005099803-2020-04372
    Event Type
    Malfunction
    Date Received
    October 5, 2020
    Date of Event
    September 14, 2020
    Report Date
    January 14, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    UDI-DI
    08714729645801
    PMA / PMN Number
    K131700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PROBLEM CODE 2944 CAPTURES THE REPORTABLE EVENT OF DEVICE CONTAMINATION. BLOCK H10: (PRODUCT INVESTIGATION): ONE CAPTIVATOR SNARE WAS RECEIVED FOR ANALYSIS. PER VISUAL INSPECTION, IT WAS FOUND THAT ONE FOREIGN MATTER (RUST) WAS FOUND OVER THE METAL CANNULA OF THE DEVICE. THE DEVICE WAS SENT TO EXTERNAL SUPPORT ANALYSIS. AS PER ANALYSIS RESULTS, A SIGNIFICANT PRESENCE OF OXYGEN, IRON AND CHLORINE AS THE COMPOSITION OF THE FM WERE DETECTED. IT IS HYPOTHESIZED THAT A SALT SOLUTION CONTACTED THE METAL CANNULA; ULTIMATELY ATTACKING THE COMPONENT TO CREATE IRON OXIDE AND PITTING. THE REPORTED EVENT WAS CONFIRMED. EXTERNAL SUPPORT ANALYSIS DETECTED SIGNIFICANT PRESENCE OF OXYGEN, IRON AND CHLORINE AS THE COMPOSITION OF THE FM. IT IS HYPOTHESIZED THAT A SALT SOLUTION CONTACTED THE METAL CANNULA; ULTIMATELY ATTACKING THE COMPONENT TO CREATE IRON OXIDE AND PITTING. AN INVESTIGATION CONCLUSION CODE OF "CAUSE NOT ESTABLISHED" WILL BE ASSIGNED TO THIS COMPLAINT SINCE THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. THERE IS AN INVESTIGATION IN PLACE TO ADDRESS THIS ISSUE. 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 CAPTIVATOR EXTRA LARGE ROUND STIFF SNARE WAS USED DURING AN INTESTINAL POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION AND OUTSIDE THE PATIENT, WHILE UNPACKING THE DEVICE AND WAS OPENED FOR USE IN A PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS RUSTED. REPORTEDLY, THE STERILE SEAL WAS INTACT AND THERE WERE NO OTHER ISSUES NOTED WITH THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. 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 STABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR EXTRA LARGE ROUND STIFF SNARE WAS USED DURING AN INTESTINAL POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION AND OUTSIDE THE PATIENT, WHILE UNPACKING THE DEVICE AND WAS OPENED FOR USE IN A PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS RUSTED. REPORTEDLY, THE STERILE SEAL WAS INTACT AND THERE WERE NO OTHER ISSUES NOTED WITH THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095885 CAPTIVATOR II SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC CORPORATION M00561291 0023872312 08714729645801

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR