BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOSCULPT PTCA SCORING BALLOON CATHETER (EX)

    MDR report key: 3023812 · Received March 22, 2013

    Report

    Report Number
    3005462046-2013-00012
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    NWX
    PMA / PMN Number
    P050018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANGIOSCULPT DEVICE GOT STUCK ON THE ABBOTT BALANCE GUIDE WIRE. THE DEVICE AND THE GUIDE WIRE WERE REMOVED AS A UNIT. THE PHYSICIAN REWIRED THE LESION TO COMPLETE THE PROCEDURE. THIS RESULTED IN PROLONGATION OF THE CASE. NO CLINICAL INJURY WAS REPORTED. THE CATH LAB REPORT AND LOG WERE RECEIVED FOR EVAL. THE LOG STATED THAT THE ANGIOSCULPT DEVICE WAS NOT DEPLOYED AND FAILED TO CROSS THE LESION, WHICH DIFFERS FORM THE COMPLAINT REPORTED. DESPITE THE DIFFERENCES FROM THE COMPLAINT TO THE CATH LAB REPORT, NO NEW INFORMATION RELATED TO THE COMPLAINT WAS NOTED IN THE REPORT. THE ANGIOSCULPT DEVICE WAS RETURNED WITH THE GUIDE WIRE INTACT. EVIDENCE OF LIFTING AT THE EX PORT SUGGEST A GUIDE WIRE PROLAPSE OCCURRED. THE RETURNED GUIDE WIRE WAS ABLE TO BE REMOVED FROM THE ANGIOSCULPT DEVICE WITH SLIGHT RESISTANCE. GUIDE WIRE PROLAPSE IS LISTED AS A POSSIBLE OCCURRENCE DURING THE PROCEDURE OF THE ANGIOSCULPT PTCA SCORING BALLOON CATHETER INSTRUCTIONS FOR USE (IFU).

    Description of Event or Problem · 1

    THE BALLOON GOT STUCK ON THE GUIDE WIRE. THE BALLOON AND THE GUIDE WIRE WERE REMOVED AS A UNIT. CATH LAB LOG/REPORT RECEIVED ON (B)(4) 2013: PER THE CATH LAB REPORT, A CARDIAC SHEATH WAS INSERTED INTO THE RIGHT FEMORAL ARTERY. AN ABBOTT BALANCE GUIDE WIRE WAS ADVANCED TO THE RIGHT POSTEROLATERAL BRANCH/ARTERY (RPLA). THE ANGIOSCULPT DEVICE WAS ADVANCED OVER THE GUIDE WIRE. THE ANGIOSCULPT DEVICE WAS REMOVED INTACT TO THE GUIDE WIRE, UNDEPLOYED, AND FAILED TO CROSS THE LESION. THE PHYSICIAN REWIRED THE RPLA TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119178 ANGIOSCULPT PTCA SCORING BALLOON CATHETER (EX) NWX ANGIOSCORE, INC. 2034-2515 F12080020

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other ABBOTT BALANCE 0.014" GUIDE WIRE (190 CM)| CORDIS 6F SHEATH (1OO MM)