BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOSCULPT EVO RX PTCA

    MDR report key: 12700974 · Received October 26, 2021

    Report

    Report Number
    3005462046-2021-00057
    Event Type
    Injury
    Date Received
    October 26, 2021
    Date of Event
    September 29, 2021
    Report Date
    August 8, 2023
    Manufacturer
    PHILIPS IMAGE GUIDED THERAPY CORPORATION
    Product Code
    NWX
    UDI-DI
    00813132026882
    PMA / PMN Number
    P050018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCKS D1/ G1: MANUFACTURER NAME AND SITE NAME WERE UPDATED FROM SPECTRANETICS TO PHILIPS IMAGE GUIDED THERAPY CORPORATION TO MATCH THE INFORMATION ON THE PRODUCT LABEL. 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

    THE PATIENT'S DOB OR AGE AT TIME OF EVENT, GENDER, AND WEIGHT ARE UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA IS UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. REPORT SOURCE: FOREIGN - (B)(6). THE ANGIOSCULPT DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND NO UNUSUAL CHARACTERISTICS OF THE DEVICE. DURING FUNCTIONAL TESTING, A LABORATORY ASAHI SION BLUE 0.014" COATED GUIDE WIRE WAS ACTIVATED WITH SALINE AND INSERTED THROUGH THE DISTAL TIP AND THROUGH THE DEVICE, BUT WITH SLIGHT RESISTANCE. USING AN INDEFLATOR FILLED WITH WATER, THE BALLOON WAS INFLATED TO 18 ATM FOR 1 MIN WITH NO LEAK OBSERVED. THE BALLOON DEFLATED WITH NO ISSUES. THE ASAHI SION GUIDE WIRE WAS SUCCESSFULLY REMOVED FROM THE DEVICE, BUT WITH SLIGHT RESISTANCE. THE ANGIOSCULPT DEVICE WAS USED OFF-LABEL. THE IFU WARNS TO NOT EXCEED THE RATED BURST PRESSURE AS INDICATED ON THE PRODUCT LABEL.

    Description of Event or Problem · 0

    THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY TORTUOUS AND MODERATELY CALCIFIED DISTAL RCA. DURING INFLATION AT ABOVE RBP (18 ATM), THE BALLOON RUPTURED. UPON REMOVAL, RESISTANCE WAS ENCOUNTERED AND THE ANGIOSCULPT AND GUIDEWIRE WERE REMOVED AS A UNIT. A NEW GUIDEWIRE AND NON-ANGIOSCULPT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. DURING THE RETURNED PRODUCT ANALYSIS, THE BALLOON RUPTURE COULD NOT BE CONFIRMED THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE ANGIOSCULPT AND GUIDEWIRE WERE REMOVED AS A UNIT. PLACEMENT OF A NEW GUIDE WIRE WAS NECESSARY TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597897 ANGIOSCULPT EVO RX PTCA CATHETER, PTCA, CUTTING/SCORING NWX PHILIPS IMAGE GUIDED THERAPY CORPORATION 2200-3010-B G21020057 00813132026882

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other ASAHI: 0.014" SION BLUE GUIDEWIRE| ASAHI: HYPERION GUIDE CATHETER SIZE UNK| TERUMO: 6F INTRODUCER SHEATH