BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOSCULPT EVO RX PTCA

    MDR report key: 12733990 · Received November 1, 2021

    Report

    Report Number
    3005462046-2021-00061
    Event Type
    Injury
    Date Received
    November 1, 2021
    Date of Event
    October 6, 2021
    Report Date
    August 8, 2023
    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
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 · 1

    THE PATIENT'S ETHNICITY AND RACE ARE UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA OR MEDICAL HISTORY ARE UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. ATTEMPTS TO OBTAIN THE INFORMATION HAS NOT BEEN SUCCESSFUL. THE ANGIOSCULPT DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND A DISTAL BOND PEEL WITH ONE LEAFLET LIFTED, BUT REMAINED INTACT TO 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, WITH SLIGHT RESISTANCE. AFTER BALLOON INFLATION/DEFLATION, WITH SLIGHT RESISTANCE THE GUIDE WIRE WAS REMOVED FROM THE DEVICE. 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 · 1

    THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE PROXIMAL RCA AND UPON REMOVAL, THE BALLOON GOT PINNED TO THE WIRE AND HAD TO BE REMOVED AS A UNIT. THE BALLOON WAS INFLATED 3 TIMES TO 18 ATM (RBP IS 16 ATM). NO ISSUES OBSERVED OR REPORTED DURING DELIVERY. THE LESION WAS REWIRED WITHOUT COMPLICATIONS TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. DURING THE RETURNED DEVICE ANALYSIS, A DISTAL BOND PEEL WAS OBSERVED. 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. IN ADDITION, THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE DISTAL BOND PEELED, POTENTIAL FOR HARM IF IT WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630940 ANGIOSCULPT EVO RX PTCA CATHETER, PTCA, CUTTING/SCORING NWX PHILIPS IMAGE GUIDED THERAPY CORPORATION 2200-3015-B G21030006 00813132026899

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female ASAHI: 0.014" SION BLUE GUIDEWIRE| BOSTON SCIENTIFIC: AL GUIDE CATHETER SIZE UNK| TERUMO: 6F INTRODUCER SHEATH