BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE

    MDR report key: 24217871 · Received January 29, 2026

    Report

    Report Number
    1118880-2026-00008
    Event Type
    Injury
    Date Received
    January 29, 2026
    Date of Event
    December 30, 2025
    Report Date
    January 29, 2026
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    UDI-DI
    00389701018318
    PMA / PMN Number
    K062446
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: IR LAB MANAGER. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. ONE 6FR IK SHEATH AND PACKAGING LABEL WERE RETURNED TO TERUMO MEDICAL CORPORATION FOR ASSESSMENT. THE SAMPLE WAS SUBJECTED TO VISUAL ANALYSIS. THE SHEATH IS SEPARATED 0.8CM FROM THE SHEATH HUB. THE BROKEN SHEATH WAS NOT RETURNED WITH THE SAMPLE. THE SHEATH AT THE SEPARATION POINT IS FRAYED AND STRETCHED. THE COMPLAINT CAN BE CONFIRMED FOR SHEATH SEPARATION. THE EXACT ROOT CAUSE CANNOT BE DETERMINED. THE LIKELY CAUSE IS THE SHEATH ENCOUNTERED RESISTANCE DURING WITHDRAW. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH TERUMO MEDICAL CORPORATION SPECIFICATIONS AND PROCEDURES AND THE DEVICE WAS RELEASED IN A CONFORMING STATE. CURRENTLY, NO ACTION IS RECOMMENDED SINCE THE RISK EVALUATION IS WITHIN THE PREDETERMINED LIMITS IN THE HAZARD BASED RISK TABLE (HBRT).

    Description of Event or Problem · 0

    TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE SHEATH WAS USED FOR UPPER ACCESS OF FISTULA AND BROKE DURING THE CASE. PHYSICIAN HAD TO CALL FOR VASCULAR SURGERY. THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) TO RETRIEVE BROKEN SHEATH. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PROCEDURE WAS A LEFT ARTERIOVENOUS SHUNT CASE WITH THROMBOSIS AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). ADDITIONAL INFORMATION WAS RECEIVED ON 09JAN2026: THERE WAS NO NOTICEABLE DAMAGE NOTED BY THE FACILITY. THE PATIENT'S CONDITION WAS STABLE FOLLOWING THE SURGICAL PROCEDURE. THERE WERE NO INSERTION DIFFICULTIES NOTED BY THE FACILITY. IT IS UNKNOWN IF THERE WAS PLAQUE AND OR STENOSIS PRESENT IN THE ACCESS SITE. IT IS UNKNOWN IF TESTING WAS PERFORMED TO ENSURE THE SHEATH WAS REMOVED ENTIRELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277711 PINNACLE INTRODUCER, CATHETER DYB TERUMO MEDICAL CORPORATION RSB605H 0001266027 00389701018318

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention