BEUDAMED
    FDA Adverse Event Summary report: N

    ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)

    MDR report key: 3192724 · Received June 21, 2013

    Report

    Report Number
    3005462046-2013-00036
    Date Received
    June 21, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 23, 2013
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    NWX
    PMA / PMN Number
    P050018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON WAS RETAINED IN THE PATIENT. TWO STENTS WERE PLACED TO SECURE THE BALLOON TO THE ARTERY WALL. A DISSECTION OCCURRED AND A STENT WAS PLACED TO TREAT THE LESION. THIS RESULTED IN PROLONGED HOSPITALIZATION AND ADDITIONAL MEDICAL INTERVENTION TO COMPLETE THE PROCEDURE. THE ANGIOSCULPT DEVICE IS WITH THE HOSPITAL'S RISK MANAGEMENT, THUS, NO EVALUATION PERFORMED. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) FOR THE ANGIOSCULPT SCORING BALLOON CATHETER, RETAINED DEVICE COMPONENTS IS LISTED AS A POSSIBLE ADVERSE EFFECT OF THE PROCEDURE.

    Description of Event or Problem · 1

    THE PHYSICIAN FIRST USED A 2.5 X 20 MM PTCA BALLOON TO DILATE THE LESION. HE THEN DECIDED TO USE THE ANGIOSCULPT 2.5 X 15 MM. AFTER INFLATING TO 18 ATM FOR ONE MINUTE, THE PHYSICIAN TRIED REMOVING THE DEVICE BUT FELT RESISTANCE AND COULD NOT REMOVE FROM THE PATIENT. WHEN THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT, THE BALLOON STAYED BEHIND AND THE SHAFT WAS REMOVED WITH THE SCORING ELEMENT. THE PHYSICIAN COULD NOT REMEMBER IF THE DEVICE RUPTURED AND IT WAS NOT NOTED ON THE CATH LAB REPORT. THE PHYSICIAN ATTEMPTED TO SNARE THE BALLOON BUT WAS UNSUCCESSFUL SO HE STENTED THE BALLOON AGAINST THE PATIENT'S VESSEL WALL. THE PHYSICIAN THINKS THE SCORING ELEMENT STAYED INTACT WITH THE SHAFT. THE PROCEDURE LASTED 4.5 HOURS. PHYSICIAN STATED THAT PATIENT IS DOING FINE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013: THE PHYSICIAN STATED THAT THE PATIENT IS STILL DOING WELL. AFTER STENTING THE CIRCUMFLEX, THE PHYSICIAN THOUGHT THE PROCEDURE WAS COMPLETED, BUT THEN REALIZED THAT THE LEFT MAIN HAD BEEN DISSECTED DURING THE PROCEDURE. THE PHYSICIAN THEN PROCEEDED TO STENT THE LEFT MAIN ARTERY WITHOUT ANY COMPLICATIONS. THE ANGIOGRAM AND THE CATH LAB LOG WERE RECEIVED FOR EVALUATION. THE CATH LAB REPORT AND THE ANGIOGRAM CORRELATES WITH THE REPORTED COMPLAINT. THE SCORING ELEMENT STRUTS WERE NOT VISIBLE ON THE ANGIOGRAM, WHICH SUGGESTS THE SCORING ELEMENT WAS REMOVED INTACT TO THE SHAFT AND WAS NOT RETAINED IN THE PATIENT. A DISSECTION ANGIOGRAPHIC RESULT SHOWED THE ANGIOSCULPT BALLOON MARKER BANDS IN THE LOCATION OF THE TWO STENTS WITH GOOD FLOW THROUGH THE CIRCUMFLEX VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282513 ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX) NWX ANGIOSCORE, INC. 2200-2515 F13030033

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| O| R