BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOSCULPT EVO RX PTCA SCORING BALLOON CATHETER WITH HYDROPHILIC COATING

    MDR report key: 25060244 · Received May 1, 2026

    Report

    Report Number
    3005462046-2026-00015
    Event Type
    Injury
    Date Received
    May 1, 2026
    Date of Event
    April 12, 2026
    Report Date
    May 1, 2026
    Manufacturer
    PHILIPS IMAGE GUIDED THERAPY CORPORATION
    Product Code
    NWX
    UDI-DI
    00813132026899
    PMA / PMN Number
    P050018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G2: FOREIGN- SAUDI ARABIA. BLOCK H3/H6: BASED ON THE DEVICE PHOTO RECEIVED, THE SCORING ELEMENT DETACHED FROM INTERMEDIATE BOND, BUT REMAINED INTACT TO THE DEVICE. THE ANGIOSCULPT CATHETER WAS NOT RETURNED, THUS THE CAUSE OF THE DAMAGED SCORING ELEMENT COULD NOT BE ESTABLISHED. PER THE IFU, DISSECTION IS LISTED AS A POSSIBLE ADVERSE EFFECT OF THE PROCEDURE. 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

    THE ANGIOSCULPT DEVICE WAS USED FOR A THERAPEUTIC CORONARY PROCEDURE IN A SEVERELY CALCIFIED PROXIMAL LAD. DURING USE, THE BALLOON WAS FOUND HANGING INSIDE THE PATIENT'S BODY, LEADING TO A DISSECTION. BASED ON THE DEVICE PHOTO RECEIVED, THE SCORING ELEMENT DETACHED FROM THE INTERMEDIATE BOND, BUT REMAINED INTACT TO THE DEVICE. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO DETACHED SCORING ELEMENT; RESULTED IN A DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84555 ANGIOSCULPT EVO RX PTCA SCORING BALLOON CATHETER WITH HYDROPHILIC COATING CATHETER, PTCA, CUTTING/SCORING NWX PHILIPS IMAGE GUIDED THERAPY CORPORATION 2200-3015-B 0303692519 00813132026899

    Patients

    Seq Age Sex Outcome Treatment
    1