BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHIDEN HP

    MDR report key: 8665439 · Received June 4, 2019

    Report

    Report Number
    3002808904-2019-00013
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    April 9, 2019
    Report Date
    May 8, 2019
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCERNED DEVICE SUBJECT TO THIS REPORTED EVENT, "SHIDEN HP", AN RX-TYPE PTA BALLOON CATHETER COMPATIBLE WITH 0.014"GUIDEWIRE, IS NOT DISTRIBUTED IN US, HOWEVER, WE INTEND TO REPORT THIS CASE AS THE EVENT OCCURRED ON ONE OF THE SIMILAR DEVICES FOR "CROSPERIO RX" , AN RX-TYPE PTA BALLOON CATHETER COMPATIBLE WITH 0.014" GUIDEWIRE, WHICH IS DISTRIBUTED IN US UNDER 510(K)#K152887. SINCE THE USED WAS NOT RETURNED TO THE MANUFACTURER, WE WERE NOT ABLE TO ANALYZE IT. IN ADDITION, WE WERE NOT ABLE TO CHECK DHR BECAUSE THE BATCH NUMBER WAS UNIDENTIFIED. ABOUT THE BALLOON RUPTURE CAUSE OF THIS MATTER, A BALLOON EXTENDED THING GUESSED IT AS POSSIBILITY BY PRESSURE ACROSS MAXIMUM EXPANSION PRESSURE (RBP) FROM MANEUVER INFORMATION, BUT WAS NOT ABLE TO IDENTIFY BLOOD VESSEL ESTRANGEMENT AND CONCRETE CAUSATION WITH THE LEAK OF THE STENT GRAFT.

    Description of Event or Problem · 1

    THIS "SHIDEN HP" PTA BALLOON CATHETER (HEREAFTER SAID "BALLOON CATHETER") WAS EMPLOYED FOR A POST-DILATATION OF THE STENT GRAFT. THE BALLOON OF THE PTA BALLOON CATHETER RUPTURED AT AN INFLATING PRESSURE OF 30 ATM -30SEC (THE RATED BURST PRESSURE (RBP) OF THIS BALLOON CATHETER;20ATM). BLOOD VESSEL BECAME ESTRANGED, AND LEAK OCCURRED FROM A STENT GRAFT. THEN, THE PHYSICIAN DETAINED A STENT GRAFT AS AN EMERGENCY MEASURE MORE AND RESTORED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461061 SHIDEN HP CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT KANEKA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention