BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHIDEN HP

    MDR report key: 14133507 · Received April 18, 2022

    Report

    Report Number
    3002808904-2022-00007
    Event Type
    Injury
    Date Received
    April 18, 2022
    Date of Event
    March 24, 2022
    Report Date
    March 25, 2022
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    PMA / PMN Number
    K152887
    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. PLEASE FIND BELOW THE RESULTS OF OUR INVESTIGATION: THE DEVICE HISTORY RECORDS (DHR) OF THE CONCERNED DEVICE WAS REVIEWED. THE PRODUCTION LOT, TO WHICH THE CONCERNED DEVICE BELONGS, PASSED ALL IN-PROCESS INSPECTIONS INCLUDING THE VISUAL TEST, SHAFT PRESSURIZED TEST AND THE BALLOON-WRAPPING TEST FOR EVERY PRODUCT, AND THE FINISHED PRODUCT INSPECTIONS INCLUDING THE SHAFT TENSILE STRENGTH TEST AND THE REPETITIVE BALLOON INFLATION/DEFLATION TEST ON REPRESENTATIVE SAMPLES BASED ON SAMPLING PLAN. NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES OF THE CONCERNED DEVICE WAS FOUND. NO NONCONFORMITY OR ABNORMALITY WAS FOUND IN THE MANUFACTURING PROCESSES ACCORDING TO THE DHR. THE CONCERNED DEVICE USED WAS NOT RETURNED FOR OUR FURTHER INVESTIGATION. PROBABLE CAUSE(S) AND OUR COMMENT: NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES OF THE CONCERNED DEVICE WAS FOUND. IT IS INFERRED THAT THIS INCIDENT WAS CAUSED BY THE TERRIBLE CALCIFIED LESION, AND IT IS JUDGED THAT THERE WERE NO PROBLEMS WITH THE MANUFACTURING OR DESIGN OF THE DEVICE.

    Description of Event or Problem · 0

    BECAUSE OF THE TERRIBLE CALCIFICATION OF THE LESION, THIS LESION WAS FIRST DILATED WITH "SHIDEN HP 2.0-40 MM". NEXT, THE LESION WAS DILATED WITH THE CONCERNED DEVICE ("SHIDEN HP 5.0-40 MM") TO INCREASE THE SIZE, AND WHEN THE CONCERNED DEVICE WAS REMOVED, IT WAS CONFIRMED THAT THERE WAS NO SHAFT FROM THE DISTAL TIP TO THE GW PORT AND THAT IT REMAINED IN THE VESSEL. THE DOCTOR ATTEMPTED TO RETRIEVE THE REMAINING BROKEN FRAGMENT IN THE VESSEL USING A SNARE, BUT WAS UNABLE TO DO SO. SINCE THERE WAS NO VASCULAR SURGERY DEPARTMENT IN THE HOSPITAL, AND THE PATIENT WAS TRANSPORTED TO ANOTHER HOSPITAL HAS THE VASCULAR SURGERY DEPARTMENT. THE BROKEN FRAGMENT WAS REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136721 SHIDEN HP CROSPERIO RX PTA BALLOON DILATATION CATHETER LIT KANEKA CORPORATION SR060535

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other