BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OHICHO3

    MDR report key: 9074389 · Received September 17, 2019

    Report

    Report Number
    3002808904-2019-00026
    Event Type
    Injury
    Date Received
    September 17, 2019
    Date of Event
    August 20, 2019
    Report Date
    August 20, 2019
    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 BALLOON PORTION WAS BROKEN AT THE CENTRAL PART OF THE BALLOON. THE GUIDE WIRE INSERTED BY EXTENDING THE CATHETER SHAFT IN THE BALLOON PORTION COULD NOT BE REMOVED. THE CATHETER SHAFT WAS EXTENDED ABOUT 4 CM. 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 SHOULD HAVE BEEN INJURED AT THE HARD AND SHARP END OF THE COMBINED DEVICE OR LESION AND BROKEN WHEN THE BALLOON WAS RUPTURED. WHILE RETRIEVING IT OUT OF THE PATIENT, THE BULKY PORTION OF THE RUPTURED BALLOON WAS CAUGHT AT THE SHEATH AND BECAME UNABLE TO PULL BACK FURTHER. NO NONCONFORMITY WAS FOUND IN THE MANUFACTURING PROCESSES OF THE DEVICE CONCERNED, AND ACCORDINGLY, WE DETERMINE THAT THE EVENT REPORTED WAS CAUSED BY NOT ANY DEFECT OF THE DEVICE BUT THE USER'S HANDLING ISSUES.

    Description of Event or Problem · 1

    OHICHO3 IS AN OTW-TYPE PTA BALLOON CATHETER COMPATIBLE WITH 0.035 INCH GUIDE WIRE. OHICHO3 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" GUIDE WIRE COMPATIBLE) IN US UNDER 510(K)# K152080", CROSSTELLA OTW" (OTW TYPE PTA BALLOON DILATATION CATHETER,0.018" GUIDE WIRE COMPATIBLE) IN US UNDER 510(K)# K160004", AND "CROSPERIO OTW" (OTW TYPE PTA BALLOON DILATATION CATHETER,0.014" GUIDE WIRE COMPATIBLE) IN US UNDER 510(K)# K160013." THE BALLOON RUPTURE OCCURRED WHEN THE BALLOON WAS INFLATED TWICE. THE OPERATOR TRIED TO WITHDRAW THE CATHETER THROUGH THE SHEATH BUT COULD NOT. THE SKIN WAS DISSECTED , AND THE CATHETER AND THE SHEATH WERE REMOVED TOGETHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868419 OHICHO3 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT SP049410

    Patients

    Seq Age Sex Outcome Treatment
    1 Other