BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOSCULPT PTCA SCORING BALLOON CATHETER (EX)

    MDR report key: 2792207 · Received October 10, 2012

    Report

    Report Number
    3005462046-2012-00060
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    NWX
    PMA / PMN Number
    P050018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTAL PORTION OF THE ANGIOSCULPT DEVICE GOT STUCK IN THE PATIENT AND WAS NOT ABLE TO BE REMOVED. TWO DES STENTS WERE USED TO STENT THE DISTAL PORTION OF ANGIOSCULPT TO THE VESSEL. THE ANGIOGRAM WAS RECEIVED FOR EVALUATION. ADDITIONAL INFORMATION WAS OBTAINED FROM THE ANGIOGRAM. THE LESION WAS LOCATED IN THE PROXIMAL LAD NEAR THE BIFURCATION OF THE LAD AND FIRST DIAGONAL BRANCH. THE ANGIOSCULPT MARKER BANDS COULD BE SEEN BEFORE AND AFTER THE ANGIOSCULPT WAS STENTED INTO THE VESSEL. THE FINAL ANGIOGRAPHIC RESULT DEMONSTRATED GOOD BLOOD FLOW THROUGH THE PROXIMAL LAD STENT AND THE MID LAD ANGIOSCULPT STENTED AREA. THE ANGIOSCULPT DEVICE WAS RETURNED WITHOUT THE DISTAL PORTION OF THE DEVICE (DISTAL TIP, SCORING ELEMENT, TRANSITION TUBING, AND NITINOL SUPPORT WIRE). IT IS ESTIMATED THAT APPROXIMATELY 66.25MM OF THE DISTAL PORTION WAS NOT RETURNED. THE DEVICE SEPARATED PROXIMAL TO THE EX PORT. A SLIGHT NECKING WAS OBSERVED AT THE SEPARATED END. BASED ON THE LAB ANALYSIS, THE EVIDENCE OF NECKING AT THE SEPARATED END SUGGESTS THAT THE USER APPLIED EXCESSIVE FORCE TO THE DEVICE RESULTING IN SEPARATION. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) FOR ANGIOSCULPT SCORING BALLOON CATHETER, IF RESISTANCE IS MET DURING USE, THE CAUSE OF THE RESISTANCE SHOULD BE EXPLORED BEFORE PROCEEDING. THE IFU LISTS RETAINED DEVICE COMPONENTS AS A POSSIBLE ADVERSE EFFECT OF THE PROCEDURE.

    Description of Event or Problem · 1

    PHYSICIAN TREATED PATIENT WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND PERIPHERAL VASCULAR DISEASE. THE ANGIOSCULPT DEVICE WAS UNABLE TO CROSS THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION. THE PHYSICIAN PRE-DILATED WITH A STANDARD BALLOON. THE ANGIOSCULPT DEVICE WAS RE-INSERTED AND ADVANCED ACROSS THE LESION AND INFLATED 1 TIME. THE PHYSICIAN HAD DIFFICULTY REMOVING THE ANGIOSCULPT DEVICE. UPON REMOVAL, IT WAS NOTED THAT THE SCORING ELEMENT AND SHAFT WERE SEPARATED. THE PHYSICIAN ADVANCED A SECOND CORONARY WIRE AND ATTEMPTED TO SNARE THE SCORING ELEMENT BUT WAS UNSUCCESSFUL. A COMPETITOR STANDARD BALLOON ADVANCED ACROSS THE SECOND BUDDY WIRE AND WAS ABLE TO PUSH THE ANGIOSCULPT AND PART OF THE SHAFT PAST THE LESION. TWO MEDTRONIC RESOLUTE DES (DRUG-ELUTING STENT) (3.0MM X 30MM AND 3.0MM X 12MM: EQUATES TO 42MM) WERE PLACED TO STENT THE PIECE OF ANGIOSCULPT IN THE VESSEL. A PROXIMAL DES WAS USED TO COVER THE INITIAL DISCRETE PROXIMAL LAD LESION. DR. (B)(6) SCRUBBED IN TO ASSIST DR. (B)(6) ONCE THE ANGIOSCULPT DIFFICULTY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSCULPT PTCA SCORING BALLOON CATHETER (EX) NWX ANGIOSCORE, INC. 2034-2510 F12040032

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention