BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESHEATH® II

    MDR report key: 22575174 · Received July 23, 2025

    Report

    Report Number
    1035166-2025-00046
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    July 11, 2024
    Report Date
    July 23, 2025
    Manufacturer
    OSCOR INC
    Product Code
    DYB
    UDI-DI
    30891492002211
    PMA / PMN Number
    K122084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS PROVIDED FOR ANALYSIS. THERE WAS NO ADVERSE EVENT WITH THE PATIENT REPORTED. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. 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. 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. WE REVIEWED THE ASSOCIATED RISK DOCUMENTATION RELATIVE TO THIS PRODUCT AND CONFIRMED THAT THIS INCIDENT IS LISTED AND THAT IT IS TRENDING WITHIN THE ESTABLISHED OCCURRENCE THRESHOLD. NO CORRECTIONS OR CORRECTIVE ACTIONS WILL BE TAKEN. DEVICE WAS NOT RETURNED FOR ANALYSIS AND REVIEW OF THE MANUFACTURING DOCUMENTS DID NOT REVEAL ANY DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THIS COMPLAINT IS NON-VERIFIABLE. CAPA WAS PREVIOUSLY OPENED TO INVESTIGATE THE PEELING ISSUE.CORRECTIVE ACTIONS WERE IMPLEMENTED, AND THE CAPA WAS EFFECTIVELY CLOSED IN AUGUST 2024 AND THE AFFECTED LOT NUMBER WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THOSE CORRECTIVE ACTIONS. 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

    PATIENT IN EP LAB FOR PACEMAKER REPLACEMENT. 6F SAFESHEATH USED FOR LEAD INSERTION. WHEN MD SPLIT SAFESHEATH, THE INNER RING OF THE SHEATH DID NOT SPLIT IN HALF AND REMAINED INTACT. MD ABLE TO MANUALLY SPLIT RING AND REMOVE. THIS HAS HAPPENED IN THE LAB IN THE PAST WITH THE SAME SIZE SHEATH. LOT# DP20264. DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2724868 SAFESHEATH® II INTRODUCER, CATHETER DYB OSCOR INC SS6 DP-20264 30891492002211

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown