BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESHEATH® II

    MDR report key: 20689183 · Received November 14, 2024

    Report

    Report Number
    1035166-2024-00122
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    October 4, 2024
    Report Date
    December 10, 2024
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    30891492002228
    PMA / PMN Number
    K122084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP 1. NO PRODUCT WAS RETURNED TO OSCOR INC. FOR EVALUATION; HOWEVER, A COMPLAINT NOTIFICATION WAS PROVIDED. WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION FOR EVALUATION, OSCOR INC. IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. BASED ON THE INFORMATION PROVIDED BY THE SUPPORTING DOCUMENTATION, WHEN PEELING AWAY THE SHEATH AFTER LEAD PLACEMENT THE VALVE DOES NOT DETACH PROPERLY. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. THE COMPLAINT IS NON-VERIFIABLE AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. OSCOR INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETE. OSCOR INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    (B)(6) 2024: PRODUCT IS NOT RETURNING. THE SALES REP HAS REQUESTED THIS INFORMATION FROM THE FACILITY AND FACILITY HAS REFUSED TO PROVIDE A RESPONSE; HENCE IT IS ASKED AND UNKNOWN.

    Description of Event or Problem · 0

    ALL SHEATHS FOUND TO HAVE THE SAME ISSUE. WHEN PEELING AWAY THE SHEATH AFTER LEAD PLACEMENT THE VALVE DOES NOT DETACH PROPERLY. THIS RESULTS IN THE OPERATOR HAVING TO CUT THE VALVE OFF WITH SCISSORS OR SCALPEL. (B)(6) 2024: IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE INTRODUCER SHEATH RUBBER VALVE WAS NOT SPLITTING PROPERLY AND GETTING STUCK TO THE LEAD. MULTIPLE SHEATHS WERE ATTEMPTED, HOWEVER REGARDLESS OF SIZE THE SAME ISSUE OCCURRED. THE SHEATHS WERE ATTEMPTED, REMOVED NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2186409 SAFESHEATH® II INTRODUCER, CATHETER DYB OSCOR INC. SS7 DP-21164 30891492002228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown