BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    MDR report key: 3022632 · Received March 20, 2013

    Report

    Report Number
    3005462046-2013-00010
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    LIT
    PMA / PMN Number
    K122685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN REWIRED THE LESION TO COMPLETE THE PROCEDURE. THIS RESULTED IN PROLONGATION OF THE CASE. NO CLINICAL INJURY WAS REPORTED BY THE PHYSICIAN. THE ANGIOSCULPT DEVICE WAS RETURNED FOR LAB ANALYSIS. VISUAL EXAMINATION CONFIRMED THE BALLOON HAS BEEN INFLATED AND AN UNEVEN SCORING ELEMENT WAS OBSERVED. ONE SCORING ELEMENT RING WAS SLIGHTLY LIFTED FROM THE DISTAL BOND AND THE SHAFT WAS NECKED APPROX 8.5 CM FROM THE PROXIMAL BOND. THE ANGIOSCULPT DEVICE WAS ATTEMPTED TO BE INFLATED BUT WAS UNABLE DUE TO THE NECKING AT THE SHAFT. BASED ON THE LAB ANALYSIS, THE EVIDENCE OF NECKING OF THE CATHETER SHAFT SUGGEST THAT THE USER APPLIED EXCESSIVE EXERTION OF FORCE.

    Description of Event or Problem · 1

    THE SCORING ELEMENT WAS DAMAGED. ADD'L INFO RECEIVED FROM REP ON (B)(4) 2013: THE LESION WAS HEAVILY CALCIFIED, 95% STENOSIS IS THE ANTERIOR TIBIAL ARTERY. THE PHYSICIAN ADVANCED THE ANGIOSCULPT BALLOON PARTIALLY IN THE LESION, BUT NOT COMPLETELY PAST THE ENTIRE DISEASE AREA. AT THIS POINT HE DECIDED TO INFLATE THE BALLOON. THE ANGIOSCULPT WAS INFLATED USING A SLOW INFLATION TECHNIQUE OF JUST A FEW ATM EACH FOR 3-5 SECONDS. THE BALLOON WAS INFLATED IN THE PROXIMAL ANTERIOR TIBIAL ARTERY AND THE PROXIMAL POPLITEAL ARTERY WITH NO ISSUES FOR ABOUT 2 MINUTES. THE BALLOON DEFLATED WITH NO ISSUES. WHEN THE PHYSICIAN RETRIEVED THE DEVICE, HE DID NOT MENTION HE WAS HAVING ANY TROUBLE UNTIL HE TOOK THE BALLOON OUT AND SHOWED IT TO ME (ANGIOSCORE SALES REP). HE ALSO DID NOT TELL ME HE TOOK OUT THE GUIDE WIRE UNTIL HE HANDED ME THE DEVICE AND ASKED FOR A NEW GUIDE WIRE. THE PHYSICIAN EASILY REWIRED THE LESION WITH A ASAHI REGALIA GUIDE WIRE AND TREATED WITH A 3.0 X 100 MM NANOCROSS BALLOON CATHETER. THE CASE WAS COMPLETED WITH NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116385 ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW) LIT ANGIOSCORE, INC. 2216-30100 F13010040

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization