BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    MDR report key: 5531989 · Received March 29, 2016

    Report

    Report Number
    3005462046-2016-00010
    Event Type
    Injury
    Date Received
    March 29, 2016
    Date of Event
    March 9, 2016
    Report Date
    March 9, 2016
    Manufacturer
    ANGIOSCORE, INC
    Product Code
    LIT
    PMA / PMN Number
    K142983
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) NUMBER FROM K122685 TO K142983.

    Additional Manufacturer Narrative · 1

    DURING REMOVAL, THE ANGIOSCULPT SEPARATED IN TWO PIECES. ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE THE SEPARATED BALLOON FROM THE PATIENT, THUS RESULTING IN PROLONGATION OF THE PROCEDURE. THE ANGIOSCULPT WAS RETURNED IN TWO PIECES. VISUAL EXAMINATION FOUND A SLIGHTLY BENT DISTAL TIP AND THE DISTAL END OF THE BALLOON WAS PULLED AWAY FROM THE SCORING ELEMENT. THE PROXIMAL END OF THE SCORING ELEMENT WAS BENT AND ONE RING WAS EXPOSED. THE TRANSITION TUBING SEPARATED PROXIMAL TO THE INTERMEDIATE BOND AND THE DISTAL SHAFT WAS SEVERELY STRETCHED AND SEPARATED AT THE PROXIMAL END OF THE BALLOON. THE INNER MEMBER SEPARATED PROXIMAL TO THE PROXIMAL MARKER BAND. BASED ON THE LAB ANALYSIS, IT IS PROBABLE THE USER APPLIED EXCESSIVE EXERTION OF FORCE RESULTING IN THE DEVICE SEPARATION. PER THE IFU, RETAINED DEVICE COMPONENT IS LISTED AS A POSSIBLE ADVERSE EFFECT OF THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE PATIENT CODES AND DEVICE CODES WERE NOT INCLUDED IN THE INITIAL MDR.

    Description of Event or Problem · 1

    THE RIGHT POSTERIOR TIBIAL (PT) ARTERY WAS TREATED WITH A TURBO ELITE. NEXT, AN ANGIOSCULPT DEVICE WAS INFLATED PER THE IFU TO 10 ATM FOR 1 MINUTE AND BALLOON WOULD NOT DEFLATE. PHYSICIAN TRIED DOUBLE/TRIPLE NEGATIVE AND BALLOON CAME DOWN SLIGHTLY. PHYSICIAN TRIED TO PULL THE ENTIRE SYSTEM OUT OVER THE GUIDE WIRE BUT WOUND UP PULLING BALLOON BACK INTO THE INTRODUCER SHEATH. THE BALLOON BROKE AT THE SHAFT/BALLOON JUNCTION AND THE BALLOON FOLLOWED WIRE BACK DOWN TO PT ARTERY. PHYSICIAN ENDOVASCULARLY SNARED THE DEVICE OUT AND REQUIRED FOLLOW-UP ANGIOPLASTY TO CORRECT THE STENOSIS WITHIN THE ARTERY. NO FURTHER INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188792 ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW) CATHETER, ANGIOPLASTY, PERIPHERAL LIT ANGIOSCORE, INC 2216-30100 F15030028

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R