BEUDAMED
    FDA Adverse Event Death Summary report: N

    VISIONS PV.014P RX DIGITAL IVUS CATHETER

    MDR report key: 8052262 · Received November 8, 2018

    Report

    Report Number
    2939520-2018-00144
    Event Type
    Death
    Date Received
    November 8, 2018
    Date of Event
    October 9, 2018
    Report Date
    October 9, 2018
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    UDI-DI
    00845225002848
    PMA / PMN Number
    K152829
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REFERENCE: (B)(4). ADDITIONAL INFORMATION PROVIDED; THE SAME PHYSICIAN PERFORMED THE DIAGNOSTIC PROCEDURE AT THE OFFICE BASED LAB (OBL) AND THE SURGICAL PROCEDURE AT THE HOSPITAL. AT THE OBL UNDER ULTRASOUND GUIDANCE, ENTRY WAS GAINED VIA EXISTING BOVINE GRAFT FOR A REVIEW OF RESTENOSIS OF THE AXILLARY BOVINE. DURING PULLBACK ON THE SECOND RUN THE IMAGE WAS LOST AND THE DEVICE BECAME STUCK. AFTER MULTIPLE ATTEMPTS TO REMOVE THE MANUFACTURER'S DEVICE, IT SEPARATED IN THE PATIENT. WHEN FURTHER ATTEMPTS WERE UNSUCCESSFUL THE PHYSICIAN REMOVED THE SHEATH (LEAVING ONE REMAINING IN PLACE), SUTURED THE ENTRY POINT, TOOK VITALS AND INSTRUCTED THE PATIENT TO GO TO THE ER WHERE THE PHYSICIAN HAD PRIVILEGES. THE PATIENT WAS REPORTEDLY IN "GOOD SHAPE" WHEN THEY LEFT THE OBL. THE DEVICE WAS STUCK IN THE SUBCLAVIAN VEIN WITH NO EXPECTATION OF MIGRATION. THE PATIENT WAS TRANSPORTED TO A NEARBY HOSPITAL WITHOUT THE AID OF EMERGENCY MEDICAL SERVICES (I.E., AMBULANCE TRANSPORT). EN ROUTE THE PATIENT ATE A CANDY BAR MOVING WHAT WAS EXPECTED TO 3PM SURGERY TO 11PM. A SURGICAL CUT DOWN WAS PERFORMED, THE REMAINDER OF THE DEVICE WAS REMOVED, AND A LEFT SUBCLAVIAN VENOUS STENT WAS PLACED. THE SURGERY WAS REPORTED TO BE SUCCESSFUL. AFTER SURGERY, WHILE BEING EXTUBATED, THE PATIENT CODED AND EXPIRED. CAUSE AND TIME OF DEATH ARE UNKNOWN. NO TESTS/LABORATORY DATA AVAILABLE. THE IMPLANT OR EXPLANT DATES ARE NOT APPLICABLE TO THIS DEVICE. THE DEVICE WAS RETURNED WITH THE PROXIMAL SHAFT SEPARATED INTO TWO PIECES AND THE DISTAL SHAFT SEPARATED. THE PROBABLE CAUSE OF THE SHAFT SEPARATION IS DAMAGE THAT OCCURRED WHILE REMOVING THE DEVICE FROM THE PATIENT. PER THE DEVICE INSTRUCTIONS FOR USE, PRECAUTIONS: IF RESISTANCE IS ENCOUNTERED DURING PULLBACK, REMOVE THE ENTIRE SYSTEM (GUIDE WIRE, CATHETER, SHEATH/GUIDE CATHETER) AT THE SAME TIME. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA.

    Description of Event or Problem · 1

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. ON (B)(6), IT WAS REPORTED DURING A DIAGNOSTIC PERIPHERAL PROCEDURE A TIGHT STENOSIS LED TO THE MANUFACTURER'S DEVICE BECOMING STUCK IN THE PATIENT. THE DEVICE BROKE OFF IN THE SUBCLAVIAN VEIN. SURGERY WAS REQUIRED TO REMOVE THE DEVICE. ON (B)(6), THE MANUFACTURER WAS MADE AWARE THE PATIENT HAD SURGERY TO REMOVE THE DEVICE FRAGMENT AND EXPIRED. THIS EVENT IS BEING REPORTED BECAUSE OF DEVICE SEPARATION, SURGICAL INTERVENTION AND PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892045 VISIONS PV.014P RX DIGITAL IVUS CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VOLCANO CORPORATION 014R 0301487381 00845225002848

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death| R