BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIONEER PLUS PPLUS120

    MDR report key: 7114785 · Received December 13, 2017

    Report

    Report Number
    2939520-2017-00090
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    November 9, 2017
    Report Date
    November 14, 2017
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    PDU
    UDI-DI
    00845225002565
    PMA / PMN Number
    K162418
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. ADDITIONAL INFORMATION INDICATED THIS WAS A THERAPEUTIC PERIPHERAL PROCEDURE. IT WAS ALLEGED THE IVUS TIP SEPARATED IN THE SUBINTIMAL SPACE AND WAS STENTED IN PLACE; HOWEVER, DEVICE ANALYSIS FOUND THE DISTAL TIP OF THE RETURNED IVUS DEVICE WAS INTACT. VESSEL WAS CTO (CHRONIC TOTAL OCCLUSION). CATHETER AND GUIDE LINER WERE REMOVED TOGETHER AS A SYSTEM. NO TESTS/LABORATORY DATA WAS AVAILABLE. SERIAL NUMBER IS NOT APPLICABLE TO THIS DEVICE. THE IMPLANT OR EXPLANT DATES ARE NOT APPLICABLE TO THIS DEVICE. THE RETURNED DEVICE WAS VISUALLY AND MICROSCOPICALLY INSPECTED. THERE WAS A BEND ON THE SCANNER JUST PROXIMAL TO THE PZT. THE WELD LEGS WERE UNEVEN IN ALIGNMENT. THE DISTAL TIP WAS SCRATCHED, BUT INTACT WITH NO PORTIONS MISSING. THE ADHESIVE OF THE DISTAL TIP FILLET WAS LIFTED, BUT INTACT WITH NO PORTIONS MISSING. THE NEEDLE FAILED TO DEPLOY. THE NEEDLE WAS INSPECTED AND APPEARED TO BE INTACT. THE INSTRUCTIONS FOR USE (IFU) LISTS INJURY TO THE VESSEL WALL (E.G. PERFORATION, DISSECTION) AS A POSSIBLE ADVERSE EFFECT. THE IFU WARNS EXTREME CARE MUST BE TAKEN TO AVOID DAMAGE TO THE VESSEL WALLS THROUGH WHICH THIS CATHETER PASSES. THE IFU CAUTIONS THE CATHETER MAY OCCLUDE SMALLER DIAMETER VESSELS. ADVANCEMENT, MANIPULATION AND WITHDRAWAL OF THE CATHETER SHOULD ALWAYS BE PERFORMED UNDER FLUOROSCOPIC GUIDANCE. IF SUBSTANTIAL RESISTANCE IS MET DURING MANIPULATION, IMMEDIATELY DISCONTINUE THE PROCEDURE AND DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING. IF THE CAUSE OF THE RESISTANCE CANNOT BE DETERMINED, WITHDRAW THE CATHETER. AVOID EXCESSIVE TORQUING OR BENDING OF THE CATHETER. TORQUING THE CATHETER EXCESSIVELY MAY CAUSE SEVERE VESSEL DAMAGE OR KINKING OF CATHETER. SHOULD THE CATHETER SHAFT BECOME KINKED, IMMEDIATELY WITHDRAW THE ENTIRE SYSTEM. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THIS COMPLAINT WILL BE MONITORED AS PART OF COMPLAINT DATA ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMAGING PART OF THE IVUS CATHETER BROKE OFF IN THE PATIENT. THE PIECE IS STILL IN THE PATIENT AND IS SUBINTIMAL. PATIENT RELEASED AS EXPECTED IN GOOD CONDITION. VESSEL LSFA, HEAVILY CALCIFIED CTO. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION. THE CUSTOMER REPORTED MEDICAL INTERVENTION WAS REQUIRED; PIECE OF A DEVICE USED IN THE PROCEDURE WAS STENTED IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893017 PIONEER PLUS PPLUS120 CATHETER FOR CROSSING TOTAL OCCLUSIONS PDU VOLCANO CORPORATION PPLUS120 G55382 00845225002565

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR