BEUDAMED
    FDA Adverse Event Injury Summary report: N

    18 SHIDEN HP

    MDR report key: 19296267 · Received May 13, 2024

    Report

    Report Number
    3002808904-2024-00003
    Event Type
    Injury
    Date Received
    May 13, 2024
    Date of Event
    April 15, 2024
    Report Date
    April 15, 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 "18 SHIDEN HP" IS A RAPID-EXCHANGE (RX) TYPE SEMI-COMPLIANT PTA BALLOON DILATATION CATHETER COMPATIBLE TO 0.018" GUIDEWIRE (GW). "18 SHIDEN HP" HAS NO APPROVAL IN THE US, HOWEVER, WE WILL REPORT THIS CASE AS AN INCIDENT OCCURRED ON A SIMILAR DEVICE FOR "CROSSTELLA RX" (A RX-TYPE PTA BALLOON DILATATION CATHETER, COMPATIBLE TO 0.018" GW) THAT IS DISTRIBUTED IN THE US UNDER 510(K) # K152873. 1.RESULTS OF INVESTIGATION 1)THE TIP OF THE DEVICE WAS CONFIRMED TO HAVE ABOUT 10 MM OF BROKEN INNER TUBE BECAUSE THE INNER TUBE WAS BROKEN AND THERE WAS NO RING MARKER ON THE TIP SIDE. THE BROKEN BALLOON PORTION WAS CONFIRMED TO BE ABOUT 60 MM, AS ABOUT 40 MM OF THE BALLOON PORTION REMAINED IN THE DEVICE. 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 DEVICE WAS DETERMINED TO BE A SERIOUS HEALTH HAZARD BECAUSE OF THE RESIDUAL FRACTURE FRAGMENTS OF THAT DEVICE AND THE CRIMPING OF THE FRACTURE FRAGMENTS WITH THE STENT. IT WAS INFERRED THAT THIS EVENT WAS CAUSED BY LESION AND TECHNIQUE DUE TO EXCESSIVE PULLING BY BEING STUCK IN THE GUIDING SHEATH AFTER BALLOON RUPTURE, AND IT WAS DETERMINED THAT THERE WERE NO MANUFACTURING OR DESIGN PROBLEMS.

    Description of Event or Problem · 0

    "18 SHIDEN HP 7.0-100 MM" WAS USED IN A SHALLOW FEMORAL ARTERY LESION (STRAIGHT RUNNING, HEAVILY CALCIFIED LESION), DILATED A TOTAL OF 3 TIMES AND RUPTURED AT 20 ATM (= RECOMMENDED DILATATION PRESSURE). THE BALLOON WAS PULLED INTO THE SHEATH BUT COULD NOT BE PULLED OUT, AND THE BALLOON TIP WAS RUPTURED WHEN THE SYSTEM WAS REMOVED. ATTEMPTS WERE MADE TO RETRIEVE THE RUPTURED FRAGMENT WITH A SNARE, BUT WERE UNSUCCESSFUL, SO THE RUPTURED FRAGMENT WAS PLACED AT THE STENTING SITE IN THE ILIAC ARTERY AND CRIMPED WITH A COVERED STENT. THE PROCEDURE WAS COMPLETED AFTER CONFIRMING GOOD BLOOD FLOW IN THE ILIAC ARTERY, THE AREA OF CRIMPING, AND IN THE SHALLOW FEMORAL ARTERY LESION, THE TREATED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843109 18 SHIDEN HP PTA BALLOON DILATATION CATHETER LIT KANEKA CORPORATION SR034713

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Other