BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOSCULPT OTW PTA

    MDR report key: 15522051 · Received September 30, 2022

    Report

    Report Number
    3005462046-2022-00049
    Event Type
    Injury
    Date Received
    September 30, 2022
    Date of Event
    September 2, 2022
    Report Date
    October 24, 2022
    Manufacturer
    THE SPECTRANETICS CORPORATION
    Product Code
    PNO
    UDI-DI
    00813132021573
    PMA / PMN Number
    K133998
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT'S DOB OR AGE AT TIME OF EVENT, WEIGHT, ETHNICITY, AND RACE 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. THE ANGIOSCULPT DEVICE WAS NOT RETURNED BY THE FACILITY, THUS NO RETURNED PRODUCT INVESTIGATION WAS PERFORMED. PER THE IFU, IF UNUSUAL RESISTANCE IS FELT WHEN THE CATHETER IS BEING MANIPULATED, CAREFULLY REMOVE THE ENTIRE CATHETER SYSTEM. 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

    BLOCK H3: THE ANGIOSCULPT DEVICE WAS RETURNED INTACT TO AN INTRODUCER SHEATH. VISUAL INSPECTION FOUND A KINK ON THE PROXIMAL PORTION OF THE BALLOON AND A DAMAGED SCORING ELEMENT. ADDITIONALLY, A DISTAL BOND PEEL WAS OBSERVED WITH 4 LEAFLETS LIFTED, BUT REMAINED INTACT TO THE DEVICE. DURING FUNCTIONAL TESTING, AN ATTEMPT TO REMOVE THE CATHETER FROM THE INTRODUCER SHEATH WAS PERFORMED, BUT UNABLE DUE TO RESISTANCE NOTED. BLOCK H6: IN THE INITIAL MDR, INVESTIGATION CONCLUSIONS CODE #22 (KNOWN INHERENT RISK OF DEVICE) WAS LISTED AND REMAINS APPROPRIATE. 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 IN A MODERATELY CALCIFIED MID SFA IN-STENT STENOSIS. THE WIRE CROSSED THE LESION AND A 2.0 LASER WAS USED. WHEN THE ANGIOSCULPT WAS INSERTED, THE DEVICE FULLY INFLATED AND DEFLATED WITH NO ISSUES. AS THE DEVICE WAS BEING REMOVED, IT WAS NOTICED THAT THERE WAS A KINK HALFWAY ACROSS THE BALLOON AND THE SCORING ELEMENT APPEARED UNORGANIZED, PREVENTING REMOVAL FROM THE 6F SHEATH. THEREFORE, THE DEVICE AND SHEATH WERE REMOVED TOGETHER AS A UNIT, KEEPING THE GUIDEWIRE IN PLACE. A NEW 6F SHEATH WAS INSERTED OVER THE WIRE FOR HEMOSTASIS AND AN ANGIOGRAM WAS PERFORMED AFTER THE SHEATH EXCHANGE TO VERIFY NO BLEEDING. THERE WAS NO INJURY TO THE VESSEL AFTER THE ANGIOGRAM WAS PERFORMED. THIS ADVERSE EVENT IS BEING REPORTED BECAUSE THE ANGIOSCULPT GOT STUCK INSIDE A NON-MANUFACTURER''S INTRODUCER SHEATH AND WERE REMOVED AS A UNIT. PLACEMENT OF A NEW SHEATH WAS NECESSARY TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2647972 ANGIOSCULPT OTW PTA CATHETER, PTA, CUTTING/SCORING PNO THE SPECTRANETICS CORPORATION 2249-60200 G22050046 00813132021573

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other ABBOTT: 0.014" CONFIANZA GUIDEWIRE.| TERUMO: 6F PRELUDE INTRODUCER SHEATH.