BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIONS PV .014P RX DIGITAL IVUS CATHETER

    MDR report key: 19954164 · Received August 9, 2024

    Report

    Report Number
    3008363989-2024-00048
    Event Type
    Injury
    Date Received
    August 9, 2024
    Date of Event
    August 1, 2024
    Report Date
    September 18, 2024
    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
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. . THE VISIONS PV .014P RX CATHETER WAS NOT RETURNED FOR EVALUATION, THUS NO RETURNED PRODUCT INVESTIGATION WAS PERFORMED. BASED ON PHILIPS CLINICAL ASSESSMENT, A LONGER INTRODUCER SHEATH (150 CM) SHOULD HAVE BEEN USED TO SUPPORT MANEUVERING OF THE CATHETER AND THE GUIDEWIRE TO THE AORTA. BLOCKS H7, H9 & H10: DO NOT APPLY TO THIS SUBMISSION. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Additional Manufacturer Narrative · 0

    BLOCKS D9 & H3: THE VISIONS PV .014P RX CATHETER WAS RETURNED FOR EVALUATION. BLOCK H3: THE VISIONS PV .014P RX CATHETER WAS RETURNED WITH A NON-PHILIPS: INTRODUCER SHEATH, UNKNOWN DEVICE, ADAPTER, AND SCISSORS. THE CATHETER WAS STICKING OUT FROM THE INTRODUCER SHEATH AND LOOPED AROUND AN UNKNOWN DEVICE. THE CATHETER DISTAL SHAFT WAS PUNCTURED AND THE CORE WIRE WAS EXPOSED, RESULTING IN A SHARP EDGE. THE PROXIMAL SHAFT WAS CUT IN TWO PIECES AT THE END OF THE WORKING LENGTH, NEXT TO THE LUER. BLOCK H6: IN THE INITIAL MDR, INVESTIGATION CONCLUSIONS CODE IMDRF# D1102 REMAINS APPROPRIATE. THE PROBABLE CAUSE IS DAMAGE DURING USE/HANDLING, LIKELY DUE TO A LACK OF SUPPORT WHICH CAUSED THE DEVICE TO KNOT AND ENTANGLE. STRAIN, IMPACT, AND FORCES ASSOCIATED WITH USE CAN AFFECT THE INTEGRITY OF THE DEVICE. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VISIONS PV .014P RX CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. ACCESS WAS GAINED FROM THE RIGHT RADIAL USING A SHORT (10 CM) NON-PHILIPS INTRODUCER SHEATH. VISIONS CATHETER WAS DELIVERED OVER A 0.014" NON-PHILIPS GUIDEWIRE, AND ADVANCED TO THE POPLITEAL. DURING PULLBACK, THE GUIDEWIRE FOLDED ONTO ITSELF IN THE AORTA MULTIPLE TIMES. THE CATHETER WAS INADVERTENTLY PULLED BACK THROUGH THE LOOPS ON THE GUIDEWIRE, TYING THE CATHETER AND GUIDEWIRE IN A KNOT. ATTEMPTS TO REMOVE VIA ENDOVASCULAR APPROACHES WERE UNSUCCESSFUL; THEREFORE, THE PATIENT WAS TRANSFERRED VIA AMBULANCE TO A HOSPITAL FOR SURGICAL REMOVAL. DEVICES WERE SUCCESSFULLY REMOVED FROM THE COMMON FEMORAL ARTERY, AND THE PATIENT IS RECOVERING. BASED ON PHILIPS CLINICAL ASSESSMENT, A LONGER INTRODUCER SHEATH (150 CM) SHOULD HAVE BEEN USED TO SUPPORT MANEUVERING OF THE CATHETER AND THE GUIDEWIRE TO THE AORTA. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO ENTRAPMENT REQUIRING SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2247984 VISIONS PV .014P RX DIGITAL IVUS CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VOLCANO CORPORATION 014R 0303220891 00845225002848

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Hospitalization ABBOTT: 0.014" COMMAND GUIDEWIRE| PHILIPS: INTRASIGHT CONSOLE| TERUMO: 6F, GLIDESHEATH 10CM INTRODUCER SHEATH