BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHIDEN HP

    MDR report key: 18814491 · Received March 1, 2024

    Report

    Report Number
    3002808904-2024-00002
    Event Type
    Injury
    Date Received
    March 1, 2024
    Date of Event
    February 8, 2024
    Report Date
    February 13, 2024
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONCERNED DEVICE "SHIDEN HP" IS A RAPID-EXCHANGE (RX) TYPE SEMI-COMPLIANT PTA BALLOON DILATATION CATHETER COMPATIBLE TO 0.014" GUIDEWIRE (GW). "SHIDEN HP" HAS NO APPROVAL IN THE US, HOWEVER, WE WILL REPORT THIS CASE AS AN INCIDENT OCCURRED ON A SIMILAR DEVICE FOR "CROSPERIO RX" (A RX-TYPE PTA BALLOON DILATATION CATHETER, COMPATIBLE TO 0.014" GW) THAT IS DISTRIBUTED IN THE US UNDER 510(K) # K152887. 1.RESULTS OF INVESTIGATION 1)THE DEVICE WAS NOT RETURNED. 2)THE DEVICE HISTORY RECORDS(DHR-BATCH RECORD)OF THE CONCERNED DEVICE WAS REVIEWED AND NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES WAS FOUND. 2.PROBABLE CAUSE AND COMMENTS: THE PATIENT'S CONDITION WAS DETERMINED TO BE A SERIOUS HEALTH HAZARD DUE TO THE BREAKAGE OF THE "SHIDEN HP 2.5-40MM" AND THE SURGICAL PROCEDURE PERFORMED TO REMOVE A PORTION OF THE PRODUCT LEFT BEHIND. THE INCIDENT WAS JUDGED TO BE CAUSED BY THE LESION AND THE USER DUE TO EXCESSIVE PULLING AFTER THE BALLOON RUPTURE STUCK IN THE LESION, AND THERE WERE NO MANUFACTURING OR DESIGN PROBLEMS.

    Description of Event or Problem · 0

    A PATIENT WITH A BELOW-KNEE ARTERY LESION HAD A BALLOON RUPTURE AFTER INFLATION THROUGH A "SHIDEN HP 2.5-40 MM" AND WAS STUCK IN THE LESION AND PULLED FORCIBLY, RESULTING IN A RUPTURED SHAFT THAT WAS UNRECOVERABLE. SUBSEQUENTLY, SURGICAL RETRIEVAL WAS ATTEMPTED, BUT THE TIP REMAINED. THE PATIENT IS CURRENTLY UNDER OBSERVATION AS BLOOD FLOW ITSELF IS MAINTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921250 SHIDEN HP PTA BALLOON DILATATION CATHETER LIT KANEKA CORPORATION SR051600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other