BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OHICHO3

    MDR report key: 7908892 · Received September 26, 2018

    Report

    Report Number
    3002808904-2018-00017
    Event Type
    Injury
    Date Received
    September 26, 2018
    Date of Event
    August 15, 2018
    Report Date
    August 30, 2018
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP, SHAFT AND SHEATH WERE RETURNED. THE BALLOON PORTION WAS BROKEN AT ABOUT 3 CM FROM THE TIP. THE INNER SHAFT WAS ELONGATED AND BROKEN, AND THE RING MARKER ON THE DISTAL SIDE FELL OFF. THE DISTAL RING MARKER WAS DISLODGED FROM THE BROKEN INNER-SHAFT AND WAS MISSING. THE DISTAL RING MARKER WAS SUSPECTED TO REMAIN IN THE PATIENT'S BLOOD VESSEL. THE DEVICE HISTORY RECORDS (DHR) OF THE DEVICE CONCERNED WAS REVIEWED: THE PRODUCTION LOT, TO WHICH THE DEVICE CONCERNED BELONGS, PASSED ALL IN-PROCESS INSPECTIONS INCLUDING THE 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 DEVICE CONCERNED WAS FOUND. PROBABLE CAUSE(S) AND OUR COMMENT: THE BALLOON WAS DAMAGED BY THE HARDENED SHARP EDGE OF THE LESION AND SHOULD HAVE RUPTURED WHEN THE BALLOON WAS INFLATED. WHILE REMOVING IT FROM THE PATIENT, THE BULKY PORTION OF THE RUPTURED BALLOON WAS CAUGHT ON THE SHEATH AND COULD NOT BE PULLED BACK ANY MORE. FURTHER ATTEMPTS TO FORCIBLY PULL BACK THE DEVICE RESULTED IN BREAKAGE OF THE BALLOON AND INNER SHAFT AND THE BROKEN PIECES AND THE RING MARKER REMAINED IN THE PATIENT'S BLOOD VESSEL.

    Description of Event or Problem · 1

    OHICHO 3 IS AN OTW-TYPE PTA BALLOON CATHETER COMPATIBLE WITH 0.035 INCH GUIDEWIRE. OHICHO 3 HAS NO APPROVAL IN USA. HOWEVER, WE INTEND TO REPORT THIS CASE AS THE EVENT OCCURRED ON THE SIMILAR DEVICE FOR "METACROSS OTW" (OTW TYPE PTA BALLOON DILATATION CATHETER, 0.035" GUIDEWIRE COMPATIBLE) IN US UNDER 510(K)# K152080", CROSSTELLA OTW" (OTW TYPE PTA BALLOON DILATATION CATHETER,0.018" GUIDEWIRE COMPATIBLE) IN US UNDER 510(K)# K160004", AND "CROSPERIO OTW" (OTW TYPE PTA BALLOON DILATATION CATHETER, 0.014" GUIDEWIRE COMPATIBLE) IN US UNDER 510(K)# K160013." THE BALLOON RUPTURE OCCURRED WHEN THE BALLOON WAS REPEATEDLY INFLATED AT THE LEFT FOREARM SHUNT (APPROXIMATELY 20 ATM). WHEN PULLING OUT, THE TIP OF THE CATHETER BROKE AND REMAINED INSIDE THE BODY. THE TIP PORTION REMAINING IN THE BODY WAS SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750726 OHICHO3 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT KANEKA CORPORATION SP068309

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| R