BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OHICHO3

    MDR report key: 8806253 · Received July 19, 2019

    Report

    Report Number
    3002808904-2019-00018
    Event Type
    Injury
    Date Received
    July 19, 2019
    Date of Event
    June 14, 2019
    Report Date
    June 26, 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 CATHETER WITHOUT DISTAL PART OF THE BALLOON WAS RETURNED. THE BALLOON PORTION WAS BROKEN AT ABOUT 2CM FROM THE TIP. 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 BEEN 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 THE TIP, AND THE BROKEN PIECES REMAINED IN THE PATIENT'S BLOOD VESSEL.

    Description of Event or Problem · 1

    OHICHO3 IS AN OTW-TYPE PTA BALLOON CATHETER COMPATIBLE WITH 0.035 INCH GUIDEWIRE. 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" 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 APPROXIMATELY 22 ATM. WHEN PULLING OUT, THE TIP OF THE CATHETER WITH DISTAL PART OF THE BALLOON BROKE AND REMAINED INSIDE THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600813 OHICHO3 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT SP039301

    Patients

    Seq Age Sex Outcome Treatment
    1 Other