BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PTA BALLOON CATHETER(OHICHO3)

    MDR report key: 7111854 · Received December 13, 2017

    Report

    Report Number
    3002808904-2017-00007
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    November 16, 2017
    Report Date
    November 17, 2017
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF A REVIEW OF THE DEVICE HISTORY RECORDS (DHR): THE DHR OF THE CONCERNED DEVICE WERE CHECKED BY THE REPORTED LOT NUMBER AND THE SERIAL NUMBER: IT WAS CONFIRMED THAT THE DEVICE PASSED ALL THE IN-PROCESS AND THE FINISHED PRODUCT INSPECTIONS, E. G., THE PRESSURE TIGHTNESS TEST, THE BALLOON FOLDING INSPECTION, THE APPEARANCE INSPECTION, WHICH ARE CARRIED OUT IN EVERY PRODUCT, AND THE BALLOON INFLATION TEST, THE TENSILE STRENGTH TEST, CONDUCTED BY REPRESENTATIVE SAMPLE. PROBABLE CAUSE(S): THE BALLOON SHOULD HAVE BEEN INJURED BY CONTACTING WITH LESIONS, AND RUPTURED WHEN THE BALLOON WAS INFLATED. WHILE RETRIEVING IT OUT OF THE PATIENT, THE BULKY PART OF THE BALLOON DUE TO THE RUPTURE WAS CAUGHT AT THE OSTIUM OF THE SHEATH AND BECAME UNABLE TO PULL BACK FURTHER OUT OF THE PATIENT. OUR COMMENTS: SINCE NO ABNORMALITIES OR PROBLEMS WAS FOUND IN THE DEVICE HISTORY RECORDS (DHR), WE DETERMINE THAT THE REPORTED PROBLEM WAS CAUSED BY NOT ANY DEFECT OF THE DEVICE BUT THE USER'S HANDLING ISSUES.

    Description of Event or Problem · 1

    THE CONCERNED DEVICE SUBJECT TO THIS REPORTED EVENT, "OHICHO 3" , AN OTW-TYPE PTA BALLOON CATHETER COMPATIBLE WITH 0.035" GUIDEWIRE (GW), IS NOT DISTRIBUTED IN US, HOWEVER, WE INTEND TO REPORT THIS CASE AS THE EVENT OCCURRED ON ONE OF THE SIMILAR DEVICES FOR "METACROSS OTW", AN OTW-TYPE PTA BALLOON CATHETER COMPATIBLE WITH 0.035" GW, WHICH IS DISTRIBUTED IN US UNDER 510(K) #152080. THIS "OHICHO 3" PTA BALLOON CATHETER (HEREAFTER "BALLOON CATHETER") WAS EMPLOYED FOR A DIALYSIS-SHUNT PTA. THE BALLOON RUPTURED AT THE THIRD DILATIONS IN THE LESION. THE PHYSICIAN TRIED TO RETRIEVE THE BALLOON CATHETER THROUGH THE SHEATH DEVICE, HOWEVER, THE BULKY PART OF THE RUPTURED BALLOON COULD NOT ENTER INTO THE SHEATH AND BECAME UNABLE TO PULL BACK FURTHER. THEN, THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY AND THE BALLOON CATHETER TOGETHER WITH THE SHEATH DEVICE WERE REMOVED BY A SURGICAL OPERATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894231 PTA BALLOON CATHETER(OHICHO3) PTA BALLOON DDILATATION CATHETER, PRODUCT CODE: LIT LIT KANEKA CORPORATION SP067286

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention