BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    MDR report key: 3093725 · Received April 26, 2013

    Report

    Report Number
    3005462046-2013-00021
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 28, 2013
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    LIT
    PMA / PMN Number
    K110767
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT INFORMATION IS UNKNOWN. THE HOSPITAL DECLINED TO PROVIDE THE INFORMATION. THE ANGIOSCULPT DEVICE GOT STUCK ON THE INTRODUCER SHEATH DURING THE ATTEMPT TO WITHDRAW THE DEVICE FROM THE PATIENT. THE PHYSICIAN TRIED DIFFERENT METHOD TO REMOVE THE DEVICE AND WAS FINALLY ABLE TO REMOVE IT BY PUSHING THE SHEATH FORWARD TO ENCOMPASS THE DEVICE. THIS RESULTED IN PROLONGATION OF THE CASE. NO CLINICAL INJURY WAS REPORTED BY THE PHYSICIAN. THE ANGIOGRAM WAS RECEIVED FROM EVALUATION. THE ANGIOGRAM CONFIRMS THE ANGIOSCULPT DEVICE HAVING DIFFICULTY BEING RETRIEVED INTO THE SHEATH. IT SHOWS A LESION JUST DISTAL TO THE SHEATH THAT THE DEVICE WAS CATCHING ON. THE PHYSICIAN STATED HE PUSHED THE SHEATH TO ASSIST IN RETRIEVAL OF THE DEVICE WHICH WAS VISIBLE ON THE ANGIOGRAM. NO NEW INFORMATION WAS OBTAINED FROM THE ANGIOGRAM WHICH CORROBORATES THE REPORTED COMPLAINT. THE ANGIOSCULPT DEVICE WAS RETURNED FOR LAB ANALYSIS. VISUAL EXAMINATION CONFIRMED A DAMAGED AND SLIGHTLY LIFTED INTERMEDIATE BOND. DURING FUNCTIONAL TESTING, A 6F LABORATORY INTRODUCER SHEATH WAS INSERTED OVER THE 0.018" GUIDE WIRE AND THRU THE INTRODUCER SHEATH WITH NO ISSUES. THE BALLOON WAS INFLATED TO 8 ATM AND DEFLATED WITH NO ISSUES. THE DEVICE WAS REMOVED FROM THE SHEATH WITH NO ISSUES. THE ANGIOSCULPT DEVICE GOT STUCK ON THE SEVERLY CALCIFIED LESION AS REPORTED BY THE PHYSICIAN AND CONFIRMED BY THE ANGIOGRAM. RETAINED DEVICE COMPONENT IS LISTED AS A POSSIBLE ADVERSE EFFECT OF THE PROCEDURE IN THE ANGIOSCULPT PTA SCORING BALLOON CATHETER INSTRUCTIONS FOR USE (IFU).

    Description of Event or Problem · 1

    THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS BALLOONED USING THE ANGIOSCULPT CATHETER AND THEN ATTEMPTED TO REMOVE THE CATHETER, BUT COULD NOT BE PULLED BACK JUST BEFORE THE INTRODUCER SHEATH. THE CATHETER SHAFT WAS ROTATED BUT STILL COULD NOT BE PULLED BACK. IT WAS ASSUMED THE CATHETER GOT STUCK AT THE CALCIFIED LESION JUST BEFORE THE SHEATH OPEN END. THE BALLOON WAS THEN INFLATED TO 6 ATM BUT STILL COULD NOT BE PULLED BACK INTO SHEATH. EVEN AFTER THE BALLOON WAS INFLATED TO 10 ATM, THE CATHETER STILL COULD NOT BE PULLED BACK INTO THE SHEATH SO THE SHEATH WAS PUSHED FORWARD TO INSERT THE BALLOON BACK INTO THE SHEATH. THIS METHOD WORKED AND THE CATHETER WAS ABLE TO BE WITHDRAWN OUTSIDE THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181730 ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW) LIT ANGIOSCORE, INC. 2076-4020 F12050037

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization CHEVALIER - GUIDE WIRE, 0.014" X 235 CM| MEDIKIT - INTRODUCER SHEATH, 6F, 11 CM