BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE

    MDR report key: 23605640 · Received November 20, 2025

    Report

    Report Number
    1118880-2025-00170
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    October 3, 2025
    Report Date
    November 20, 2025
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    UDI-DI
    00389701007595
    PMA / PMN Number
    K003424
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO PROVIDE ADDITIONAL INFORMATION IN SECTION B5 AND PROVIDE THE MEDWATCH RECEIVED, TO UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. BASED ON THE EVALUATION OF THE RETURNED SAMPLE THIS REPORT IS NOW DEEMED NOT REPORTABLE. ONE 6FR IK SHEATH AND PACKAGING WERE RETURNED TO TERUMO MEDICAL CORPORATION FOR ASSESSMENT. THE SAMPLE WAS SUBJECTED TO VISUAL ANALYSIS. THE SIDE TUBING IS SEPARATED AT THE SHEATH HUB. NO OTHER DAMAGE OR DEFORMITIES WERE NOTED ON THE SHEATH. ONE 6FR IK SHEATH AND PACKAGING WERE RETURNED FOR ASSESSMENT AND THE SIDE TUBE IS SEPARATED FROM THE SHEATH HUB. THE COMPLAINT CAN BE CONFIRMED FOR SIDE TUBE SEPARATION. THE EXACT ROOT CAUSE CANNOT BE DETERMINED. MANUFACTURING WAS NOTIFIED ABOUT THIS ISSUE. 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. CURRENTLY, NO ACTION IS RECOMMENDED SINCE THE RISK EVALUATION IS WITHIN THE PREDETERMINED LIMITS IN THE HAZARD BASED RISK TABLE (HBRT).

    Additional Manufacturer Narrative · 0

    A4: WEIGHT: 72.6KG. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED . D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: NURSE MANAGER CATH LAB. 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.

    Description of Event or Problem · 0

    TERUMO MEDICAL RECEIVED FDA MEDWATCH REPORT # MW5178313 ON 20NOV2025. THE EVENT DESCRIPTION STATES: "TUBING FROM SHEATH CAME OFF."

    Description of Event or Problem · 0

    TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: WHILE CLOSING THE ACCESS SITE THE TUBING FROM THE SHEATH DETACHED UNEXPECTEDLY. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON 27OCT2025: THE LEFT HEART CATHETERIZATION WAS COMPLETED SUCCESSFULLY. THE SHEATH WAS IN PLACE AND THE STAFF NOTICED THAT THE TUBING RANDOMLY DISCONNECTED WITHOUT ANY APPLICATION OF FORCE NOTED. THEY WERE ABLE TO EXCHANGE FOR AN ANGIO-SEAL 6FR SHEATH AND CLOSE THE ARTERIOTOMY WITH MINIMAL BLOOD LOSS AND NO PATIENT HARM. THERE WERE NO ADDITIONAL SUPPLIES NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2578423 PINNACLE INTRODUCER, CATHETER DYB TERUMO MEDICAL CORPORATION RSB603 0000756900 00389701007595

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female STANDARD CATHETERS