BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOSCULPT EVO RX PTCA

    MDR report key: 17375402 · Received July 22, 2023

    Report

    Report Number
    3005462046-2023-00025
    Event Type
    Injury
    Date Received
    July 22, 2023
    Date of Event
    June 9, 2023
    Report Date
    July 21, 2023
    Manufacturer
    PHILIPS IMAGE GUIDED THERAPY CORPORATION
    Product Code
    NWX
    UDI-DI
    00813132026936
    PMA / PMN Number
    P050018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A: THE PATIENT''S DOB OR AGE AT TIME OF EVENT, GENDER, WEIGHT, ETHNICITY, AND RACE ARE UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. BLOCK B6/B7: PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA OR MEDICAL HISTORY ARE UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. BLOCK G2: FOREIGN- FRANCE / OTHER- COMPETENT AUTHORITY. BLOCK H3: THE ANGIOSCULPT DEVICE WAS NOT RETURNED FOR EVALUATION BY THE FACILITY, THUS NO RETURNED PRODUCT INVESTIGATION WAS PERFORMED. BLOCK H6: BASED ON THE COMPLAINT DETAILS, IT IS LIKELY THAT THE PATIENT CONDITION (STENT AND ANGULATION) CAUSED OR CONTRIBUTED TO THE RETRACTION PROBLEM. 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

    DETAILS OBTAINED FROM THE FRANCE COMPETENT AUTHORITY ON 10JUL2023: DURING DILATATION OF THE CIRCUMFLEX ARTERY, THE ANGIOSCULPT BALLOON WAS INFLATED, BUT DID NOT DEFLATE AND WAS OCCLUSIVE IN THE ARTERY. ADDITIONAL INFORMATION OBTAINED FROM THE PHILIPS REPRESENTATIVE ON 20JUL2023: THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY FIBROUS PROXIMAL CIRCUMFLEX ARTERY. THE BALLOON WAS INFLATED TO 10 ATM AND DEFLATED WITH NO ISSUES. DURING REMOVAL, DIFFICULTY WAS NOTED DUE TO THE OLD STENT AND ANGULATION. A PARALLEL WIRE AND ANOTHER BALLOON WERE USED TO REMOVE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A NON-ANGIOSCULPT DEVICE. NO PATIENT INJURY WAS REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE RETRACTION PROBLEM, REQUIRING ADDITIONAL INTERVENTION FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2147366 ANGIOSCULPT EVO RX PTCA CATHETER, PTCA, CUTTING/SCORING NWX PHILIPS IMAGE GUIDED THERAPY CORPORATION 2200-3515-B G23030001 00813132026936

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention MEDTRONIC: 6F LAUNCHER GUIDE CATHETER| TERUMO: 0.014" RUNTHROUGH GUIDEWIRE| TERUMO: 6F INTRODUCER SHEATH