BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENRI

    MDR report key: 6203727 · Received December 25, 2016

    Report

    Report Number
    9614654-2016-00005
    Event Type
    Malfunction
    Date Received
    December 25, 2016
    Date of Event
    February 1, 2016
    Report Date
    February 2, 2016
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCERNED DEVICE "SENRI" (RX-TYPE PTA BALLOON DILATATION CATHETER, 0.018" GUIDEWIRE COMPATIBLE) IS NOT DISTRIBUTED IN US. HOWEVER, WE INTEND TO REPORT THIS CASE AS THE EVENT 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. SP074045 WAS REVIEWED AND NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES WAS FOUND. THE LOT PASSED ALL IN-PROCESS INSPECTIONS INCLUDING, THE GUIDEWIRE LUMEN INTEGRITY TEST, THE BALLOON INFLATED AND FOLDED-SHAPE CHECK AND THE SHAFT-PRESSURIZED TEST FOR EVERY PRODUCT AND THE FINISHED PRODUCT INSPECTIONS INCLUDING THE BALLOON-REPETITIVE INFLATION/DEFLATION TEST AND THE SHAFT TENSILE STRENGTH TEST ON REPRESENTATIVE SAMPLES BASED ON SAMPLING PLAN. THE CONCERNED USED DEVICE "SENRI", THE MAIN CATHETER SHAFT WITH THE CORE-WIRE AND SEPARATED HUB-PARTS, WAS RETURNED AND INVESTIGATED. - THE DISTAL PORTION OF THE CATHETER SHAFT INCLUDING THE TIP, THE BALLOON AND THE ENTIRE GUIDEWIRE (GW) LUMEN, WHICH MAKES MORE THAN 30CM LONG AS A TOTAL, WAS TORN OFF AND MISSING. - THE PROXIMAL END OF THE SHAFT WAS ELONGATED AND TORN OFF, AND THE HUB-PARTS WITH THE STRAIN RELIEF WAS SEPARATED FROM THE CATHETER SHAFT. ACCORDING TO THE PHYSICAL STRUCTURE OF THE RETURNED DEVICE AS INVESTIGATED AND THE INFORMATION PROVIDED, WE SPECULATE THE REPORTED SITUATION AS FOLLOWS: THE GW EXIT-PORT OF THE SENRI WAS STUCK AT THE ORIFICE OF THE INTRODUCER DEVICE WHILE RETRIEVING THE SENRI OVER THE GW (IT MIGHT BE POSSIBLE THAT THE GW MADE A LOOP OR A BENT BETWEEN THE GW EXIT PORT OF THE SENRI AND THE ORIFICE OF THE INTRODUCER DEVICE), AND THE CATHETER SHAFT WAS FINALLY TORN OFF ACCORDING TO FURTHER ATTEMPTS TO WITHDRAW FORCIBLY THE SENRI IN THE PATIENT'S VESSEL. IN CONCLUSION, THE INCIDENT IS DETERMINED NOT TO BE CAUSED BY ANY DEFECT OF THE DEVICE. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE INSTRUCTIONS-FOR-USE (IFU). THE DEVICE RISK ANALYSIS DOES ADDRESS THIS ISSUE. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW UP. THIS REPORT IS DELAYED BECAUSE IT WAS SENT TO THE EMDR TEST INSTEAD OF PRODUCTION.

    Description of Event or Problem · 1

    SUPERFICIAL FEMORAL ANGIOPLASTY LEFT HUMERAL WAY. TIGHT STENOSIS FEMORAL SUPERFICIAL MEDIO-CRURAL, NO ILIAC LESIONS. INTRODUCER WAS A DESTINATION 5FR 90CM. AFTER CROSSING THE LESION WITH 0.018" GUIDEWIRE (GW), THE BALLOON CATHETER (SENRI) WENT DOWN WITHOUT ANY DIFFICULTY OR RESISTANCE. THE SHAFT OF THE BALLOON CATHETER WAS TOO SHORT TO REACH THE LESION (1CM), AN THE BALLOON WAS NOT INFLATED AND REMOVED IMMEDIATELY. DURING REMOVAL, THE BALLOON GOT STUCK AND THE PROXIMAL END OF THE SHAFT (LUER END AND FOLLOWING PORTION) GOT DETACHED. THE BALLOON AND SHAFT WERE MOVED BACK AND FORTH SO TO LOOSEN IT FROM THE BLOCKAGE FOR REMOVAL. THE SHAFT GOT THEN DETACHED FROM THE BALLOON WHICH REMAINED IN PLACE IN THE SUPERFICIAL FEMORAL. THE SHAFT WAS REMOVED WHILE THE BALLOON REMAINED THERE ON THE GW. THE GW WAS CAREFULLY REMOVED WHICH BROUGHT BACK THE BALLOON TO THE EXTERNAL ILIAC. THERE, THE GW AND THE BALLOON GOT SEPARATED. THEN AN ATTEMPT TO EXTRACT WITH A LASSO (EV3) FAILED. IT WAS DECIDED TO IMPACT THE BALLOON IN THE EXTERNAL ILIAC TO PREVENT SECONDARY EMBOLIZATION, THIS WAS DONE WITH TWO STENTS 7 - 80 AND 40 MM (EVERFLEX EV3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853762 SENRI CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT KANEKA CORPORATION BD-S6080L SP074045

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other TERUMO 0.018" GUIDEWIRE| TERUMO DESTINATION 5FR 90CM