BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENRI

    MDR report key: 6203733 · Received December 25, 2016

    Report

    Report Number
    9614654-2016-00012
    Event Type
    Malfunction
    Date Received
    December 25, 2016
    Date of Event
    May 4, 2016
    Report Date
    May 12, 2016
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCERNED DEVICE "SENRI" IS A RAPID-EXCHANGE TYPE SEMI-COMPLIANT PTA BALLOON CATHETER COMPATIBLE TO 0.018-INCH GUIDEWIRE (GW)."SENRI" 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 RECORDS (DHR - BATCH RECORD) OF THE SENRI WITH LOT NO. SP124047 WAS REVIEWED AND NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES WAS FOUND. THE LOT PASSED ALL THE IN-PROCESS INSPECTIONS INCLUDING THE SHAFTPRESSURIZED TEST BY EVERY PRODUCT AND THE FINISHED PRODUCT INSPECTIONS INCLUDES SHAFT TENSILE STRENGTH TEST BY SAMPLING PLAN. THE CONCERNED USED DEVICE SENRI WAS RETURNED AND INVESTIGATED: A WHOLE STRUCTURE OF THE SENRI WAS RETURNED. THE SENRI WAS SEPARATED INTO TWO PORTIONS; (A) THE TIP AND THE DISTAL PORTION OF THE SHEARED OFF SHAFT AND (B) THE ENTIRE PROXIMAL PORTION BEYOND THE SHEARED OFF CATHETER SHAFT. THE BALLOON WAS DEFORMED INTO BELLOWS-SHAPE AND THE BALLOON LENGTH WAS SHRUNK TO 12MM FROM 40MM OF ITS ORIGINAL.THE DISTAL PART OF THE OUTER SHAFT WAS BROKEN AT 190MM FROM THE DISTAL TIP. THE INNER SHAFT (THE GUIDEWIRE LUMEN) WAS BROKEN AT 260MM FROM THE DISTAL TIP, AND THE BROKEN PART WAS DEFORMED INTO BELLOWS-SHAPE. IN THE PROXIMAL PORTION OF THE SHEARED OFF SHAFT, THE OUTER SHAFT AND THE INNER SHAFT WERE TORN APART IN THE DIRECTION ALONG THE LONG AXIS BETWEEN 1,205MM AND 1,340MM FROM THE ROOT OF THE STRAIN RELIEF. THE INNER SHAFT WAS BROKEN AT 1,240MM FROM THE ROOT OF THE STRAIN RELIEF. NONE OF MISSING PARTS OR FRAGMENTS OF THE RETURNED SENRI WAS FOUND AND WE BELIEVE THAT NONE OF THE BROKEN FRAGMENTS OF THE DEVICE REMAINS IN THE PATIENT. WE SPECULATE THAT FIRST THE OUTER SHAFT TOGETHER WITH THE INNER SHAFT (THE GUIDEWIRE LUMEN) WAS TORN APART FROM THE GUIDEWIRE PORT TOWARD THE DISTAL BY THE GUIDEWIRE, WHICH WAS LOOPED APART BETWEEN THE GUIDEWIRE PORT OF THE SENRI AND THE ORIFICE OF THE GUIDING SHEATH, WHILE THE SENRI WAS PULLED BACK INTO THE GUIDING SHEATH. THEN, THE FURTHER ATTEMPT TO PULL INTO THE GUIDING SHEATH FORCIBLY THE SENRI, WHICH INSUFFICIENTLY REWRAPPED BALLOON WAS STUCK AT THE ORIFICE OF THE GUIDING SHEATH, RESULTED IN THE SHEARED OFF OF THE OUTER SHAFT AND THEN INNER SHAFT. THE REPORTED PROBLEM IS DETERMINED NOT TO BE CAUSED BY ANY DEFECT OF THE DEVICE. "THIS REPORT IS DELAYED BECAUSE IT WAS SENT TO THE EMDR TEST INSTEAD OF PRODUCTION."

    Description of Event or Problem · 1

    USED FOR PATIENT WITH SFA STENOSIS FROM CONTRALATERAL ACCESS. USED DESTINATION, PUSHED SENRI OVER ADVANTAGE GUIDEWIRE 0.018 ACROSS CALCIFIED LESION. INFLATED AND RELEASED PRESSURE. REMOVED DELIVERY SHAFT OF SENRI WITHOUT BALLOON ATTACHED. SCREENED, WAS STILL IN PATIENT POPLITEAL. RECOVERED AS STILL OVER WIRE THROUGH A LARGE BORE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853718 SENRI PTA BALLOON DILATATION CATHETER LIT KANEKA CORPORATION BD-S2040L SP124047

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GUIDEWIRE ADVANTAGE(TERUMO)| SHEATH DESTINATION(TERUMO)