BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHIRANUI EX

    MDR report key: 6203732 · Received December 25, 2016

    Report

    Report Number
    9614654-2016-00011
    Event Type
    Malfunction
    Date Received
    December 25, 2016
    Date of Event
    April 20, 2016
    Report Date
    April 22, 2016
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCERNED DEVICE "SHIRANUI EX" IS A RAPID-EXCHANGE TYPE SEMI-COMPLIANT PTA BALLOON CATHETER COMPATIBLE TO 0.018-INCH GUIDEWIRE (GW). "SHIRANUI EX" HAS NO APPROVAL IN US, HOWEVER, WE WILL REPORT THIS CASE AS AN INCIDENT OCCURRED ON THE SIMILAR DEVICE FOR "CROSSTELLA RX" (RX-TYPE PTA BALLOON DILATATION CATHETER, 0.018" GUIDEWIRE COMPATIBLE) THAT IS DISTRIBUTED IN US UNDER 510(K) # K152873, AND SO ON. THE DEVICE HISTORY RECORD (DHR) OF "SHIRANUI EX" WITH LOT NO. SP036201 WAS REVIEWED AND NO NONCONFORMITY OR ABNORMALITY WAS FOUND IN ITS MANUFACTURING PROCESSES. THE DEVICE MET ITS MATERIAL, ASSEMBLING AND PRODUCT SPECIFICATIONS. THE CONCERNED USED DEVICE "SHIRANUI EX" WAS RETURNED AND INVESTIGATED: - THE DISTAL TORN OFF PORTION OF THE BALLOON WITH THE DISTAL TIP AND THE PROXIMAL PORTION FROM THE BALLOON- AND THE SHAFT-TORN OFF POSITION TILL THE PROXIMAL END (HUB-PARTS) OF THE CATHETER WERE RETURNED. - THE BALLOON WAS TORN OFF AT C.A. 25MM FROM THE DISTAL EDGE. - THE CATHETER SHAFT PROXIMAL THE BALLOON WAS ELONGATED. PROBABLE CAUSE AND COMMENTS: WE SPECULATE THE REPORTED SITUATION AS FOLLOWS: THE BALLOON WAS INJURED AND FINALLY BURST AFTER REPETITIVE DILATATIONS OF THE COMPLICATED ANASTOMOTIC REGION STENOSIS, WHEN THE DOCTOR TRIED TO WITHDRAW THE CATHETER OUT OF THE PATIENT, THE BURST AND BULKY BALLOON PORTION WAS TRAPPED IN THE LESION OR THE ORIFICE OF THE SHEATH DEVICE, AND BY FURTHER ATTEMPTS TO WITHDRAW FORCIBLY THE CATHETER, THE BALLOON AND THE INNER SHAFT WAS TORN OFF AND THE DISTAL PORTION OF THE BROKEN BALLOON-PORTION REMAINED IN THE PATIENT'S VESSEL. THE REPORTED PROBLEM IS DETERMINED NOT TO BE CAUSED BY ANY DEFECT OF THE DEVICE. THIS REPORT IS LATE BECAUSE WE WERE SENT TO THE TEST EMDR INSTEAD OF PRODUCTION.

    Description of Event or Problem · 1

    THIS BALLOON CATHETER WAS USED FOR A PTA IN THE ANASTOMOTIC REGION STENOSIS. THE DOCTOR INFLATED THE BALLOON TEN TIMES AS A TOTAL AT 18 ATM IN THREE LESIONS, AND THEN THE BALLOON BURST. WHEN HE PULLED OUT THE CATHETER FROM THE PATIENT, IT WAS FOUND THAT THE HALF OF THE BALLOON WITH THE DISTAL TIP WAS MISSING. THE DOCTOR PLACED ANOTHER BLOOD-ACCESS ON THE PATIENT AND RECOVERED THE BROKEN BALLOON PORTION REMAINED IN THE PATIENT VESSEL BY USING A SNARE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853717 SHIRANUI EX PTA BALLOON DILATATION CATHETER LIT KANEKA CORPORATION SP036201

    Patients

    Seq Age Sex Outcome Treatment
    1 Other