BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC

    MDR report key: 15504392 · Received September 29, 2022

    Report

    Report Number
    0001450997-2022-00008
    Event Type
    Injury
    Date Received
    September 29, 2022
    Date of Event
    August 5, 2022
    Report Date
    September 28, 2022
    Manufacturer
    NORTHGATE TECHNOLOGIES, INC
    Product Code
    FFK
    UDI-DI
    00817183020448
    PMA / PMN Number
    K130368
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CAPA (B)(4) WAS INITIATED TO INVESTIGATE THE EVENT. ADDITIONAL QUESTIONS WERE FOLLOWED UP WITH THE DISTRIBUTOR WHICH ALSO INCLUDED REQUEST FOR INFORMATION ON THE LOT NUMBER OF THE PROBE. ON (B)(6) 2022 , THE DISTRIBUTOR PROVIDED ADDITIONAL INFORMATION THERE WAS NO KNOWN DEVICE PROBLEM, THE PATIENT WAS NOT IN A SEVERE SITUATION FROM THE EVENT AND HAS RECOVERED. THE DISTRIBUTOR ALSO PROVIDED THE 3 MOST PROBABLE LOTS THAT COULD LIKELY HAVE BEEN USED IN THE COMPLAINT EVENT. A DEVICE HISTORY RECORD REVIEW IS BEING PERFORMED AGAINST ALL THE THREE PROBABLE LOTS. BSC16045: MANUFACTURED MAY 2022. ONLY REJECT REPORTS INDICATED WERE ISSUED FOR FOREIGN MATERIAL AND SECONDARY PACKAGING DAMAGE. ALL NON-CONFORMING MATERIAL WAS SCRAPPED. BSC16043: MANUFACTURED MAY 2022. NO MATERIAL REJECT REPORTS WERE INITIATED FOR THIS LOT. BSC15877: MANUFACTURED MARCH 2022. ONLY REJECT REPORT ISSUED WERE ISSUED FOR SECONDARY PACKAGING DAMAGE. ALL NON-CONFORMING MATERIAL WAS SCRAPPED. AS INDICATED IN THE COMPLAINT DESCRIPTION BY THE INITIAL COMPLAINANT POINTS TO PROBE BEING FIRED BY THE PHYSICIAN AGAINST THE TISSUE DURING TREATMENT OF ACCUMULATED STONE IN CBD "IT WAS THOUGHT THAT THE CAUSE OF THE PERFORATION WAS CAUSED BY THE EHL PROBE COMING INTO CONTACT WITH THE BILE DUCT WALL SEVERAL TIMES" WHICH COULD BE THE CAUSAL FACTOR TOWARDS PATIENT REQUIRING EMERGENCY SURGERY POST PROCEDURE. LABELING WARNS TO AVOID FIRING THE PROBE AGAINST THE TISSUE AND TO AVOID INJURY TO THE PATIENT FROM TISSUE DAMAGE OR PERFORATION. IF FURTHER INFORMATION WAS TO BECOME AVAILABLE OR PRODUCT RETURNED FROM THE FIELD FOR FURTHER INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED AT THAT TIME.

    Description of Event or Problem · 0

    ON (B)(6) 2022 NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF AN ALLEGED EVENT FROM DISTRIBUTOR BOSTON SCIENTIFIC, "PER CNF, IT WAS REPORTED THAT: SPYDS+EHL WAS PERFORMED ON A CASE OF ACCUMULATED STONES OF COMMON BILE DUCT STONES, BUT AFTER THE SURGERY BILE DUCT PERFORATION WAS SUSPECTED, AND THE NEXT DAY CT SHOWED THE DIAGNOSIS WITH A BILE DUCT PERFORATION, SO AN EMERGENCY SURGERY WAS PERFORMED PROMPTLY. IT WAS THOUGHT THAT THE CAUSE OF THE PERFORATION WAS CAUSED BY THE EHL PROBE COMING INTO CONTACT WITH THE BILE DUCT WALL SEVERAL TIMES. FORTUNATELY, THE PATIENT WAS NOT IN A SEVERE SITUATION AND THE PATIENT RECOVERED. IT WAS SAID THAT, LOOKING AT SYSTEMATIC REVIEWS OVERSEAS, PERFORATION OCCURS ABOUT 1-10%, SO I FELT THAT CARE SHOULD BE TAKEN IN CASES WHERE BILE DUCTS ARE DILATED BY COMMON BILE DUCT PILED STONES, CASES WHERE IT IS IMPACTED ON THE BILE DUCTS, AND CASES WHERE THE BILE DUCTS ARE IN A VERTICAL POSITION WITH RESPECT TO EHL PROBES. PROCEDURE OUTCOME: THE PROCEDURE WAS COMPLETED USING THIS DEVICE. SCOPE USED? YES GUIDEWIRE USED? YES GENERATOR/CONTROLLER USED? YES OTHER USED? UNKNOWN","ENDOSCOPIC PAPILLOTOMY 3. ACCOMPANIED BY BILIARY SCOPIC LITHOTRIPSIS". ADDITIONAL QUESTIONS WERE FOLLOWED UP WITH THE DISTRIBUTOR. ON (B)(6) 2022 , THE DISTRIBUTOR PROVIDED ADDITIONAL INFORMATION THERE WAS NO KNOWN DEVICE PROBLEM, THE PATIENT WAS NOT IN A SEVERE SITUATION FROM THE EVENT AND PATIENT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767887 AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC INTRA-CORPOREAL HYDRAULIC LITHOTRIPSY (IEHL) PROBE FFK NORTHGATE TECHNOLOGIES, INC 72-00322-0 UNKNOWN 00817183020448

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O