BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSCULPT PTA SCORING BALLOON CATHETER

    MDR report key: 1934285 · Received December 3, 2010

    Report

    Report Number
    3005462046-2010-00028
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 5, 2010
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    LIT
    PMA / PMN Number
    K100303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: VISUAL EXAMINATION OF THE RETURNED CATHETER FOUND PEELING OF THE DISTAL BOND MATERIAL AND DISTAL BOND DISRUPTION. ALSO, IT WAS OBSERVED THAT TWO (2) INNER LEAFLETS AT THE DISTAL BOND WERE DETACHED AND WERE NOT PRESENT. A SEGMENT OF THE PROXIMAL END OF THE SCORING ELEMENT RING WAS FRACTURED AND DETACHED FROM THE INTERMEDIATE BOND. HOWEVER, THE DISTAL END OF THIS SEGMENT WAS INTACT TO THE CATHETER. THE SCORING ELEMENT WAS FRACTURED AT TWO (2) RING LOCATIONS. LOCATION OF THE DETACHED INNER LEAFLETS AT THE DISTAL BOND IS UNK. THE DETACHED LEAFLETS WERE DISCOVERED DURING DEVICE EVAL AND WAS NOT REPORTED BY THE CUSTOMER. RETAINED DEVICE COMPONENTS IS A POTENTIAL ADVERSE EFFECT OF PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURES AND IS LISTED IN THE ANGIOSCULPT DEVICE IFU. HOWEVER, IN THIS EVENT, THE PROCEDURE WAS CONCLUDED WITH NO PT ADVERSE OUTCOME. HOSPITAL HAS DECLINED TO RELEASE THE CATH LAB PROCEDURE LOG/REPORT AND PROCEDURAL ANGIOGRAM.

    Description of Event or Problem · 1

    INITIAL INFO RECEIVED: VASCULAR DILATION WAS CONDUCTED WITH A STARLING MR 2.0 X 20MM AND A PTA BALLOON 3.0 X 20MM MANUFACTURED BY SJM, AND THEN WITH THIS PRODUCT TO TREAT THE LESION IN THE LEFT SUBCLAVIAN ARTERY. AS A RESULT, THE LESION WAS EXPANDED SUCCESSFULLY, ALTHOUGH RESISTANCE WAS EXPERIENCED DURING THE RETRACTION OF THE PRODUCT (WHEN THE BALLOON WAS PUT BACK IN THE SHEATH AS REPORTED). FOR THIS REASON, WE EXAMINED THE PRODUCT AFTER RETRACTION TO FIND THE PROXIMAL JOINT OF ITS SCORING ELEMENT DISENGAGED. THE PROCEDURE WAS FINISHED AT THAT POINT. NO HEALTH DAMAGE TO THE PT WAS CAUSED. ADD'L INFO RECEIVED: THE ANGIOSCULPT WAS INFLATED SIX TIMES IN THE LESION AS FOLLOWS: FIRST AND SECOND: 18 ATMOSPHERES / 120 SECONDS (EXCEEDED RATED BURST PRESSURE); THIRD: 12 ATMOSPHERES / 60 SECONDS; FOURTH TO SIXTH: 18 ATMOSPHERES / 120 SECONDS (EXCEEDED RATED BURST PRESSURE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSCULPT PTA SCORING BALLOON CATHETER LIT ANGIOSCORE, INC. 2076-5020 F09120037

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR