BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC

    MDR report key: 13078044 · Received December 23, 2021

    Report

    Report Number
    0001450997-2021-00011
    Event Type
    Malfunction
    Date Received
    December 23, 2021
    Date of Event
    November 25, 2021
    Report Date
    December 20, 2021
    Manufacturer
    NORTHGATE TECHNOLOGIES INC.
    Product Code
    FFK
    UDI-DI
    00817183020448
    PMA / PMN Number
    K130368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NORTHGATE TECHNOLOGIES, INC WAS MADE OF THE ALLEGED ISSUE ON (B)(6) 2021," NO PATIENT COMPLICATIONS WHILE FIRING THE PROBE THE DISTAL TIP BROCK OFF. (REDACTED DR. NAME) REMOVED THE PROBE BUT WAS UNABLE TO RETRIEVE THE BROKEN PIECE. HE DECIDED TO TRY A NEW PROBE TO COMPLETE THE FRACTURING OF THE PANCREATIC STONE." THE PATIENT DID NOT INCUR ANY INJURY WITH NO HEALTH CONSEQUENCES OR IMPACT FROM THE PROCEDURE. (B)(4) WAS INITIATED TO INVESTIGATE THIS COMPLAINT FURTHER. PER (B)(4): THE INTENDED USE OF THE AUTOLITH TOUCH PROBES ARE FOR THE USE OF FRAGMENTATION OF BILIARY CALCULI (STONES THAT LOCATED IN THE CYSTIC DUCT, HEPATIC DUCTS AND COMMON BILE DUCT) WHEN USED IN CONJUNCTION WITH A LITHOTRIPTER. THE POTENTIAL FOR AN INJURY FROM A COMPLETELY BROKEN OFF TIP INTO THE PANCREATIC DUCT HAS NOT BEEN EVALUATED IN A CLINICAL SETTING. THE NUMBER OF EHL PULSE ACTIVATIONS DELIVERED IS UNKNOWN AT THE TIME OF TIP EXPULSION AND THIS INFORMATION WAS NOT AVAILABLE FROM THE CUSTOMER. THE TIP DETACHING ITSELF FROM THE PROBE IS A KNOWN FAILURE MODE OF THE PROBE AND EXPECTED PROBE LIFE ABOUT 1,200 PULSES. THE TIP BEING EXPELLED WITHIN THE BILIARY / URINARY SYSTEM HAS BEEN ASSESSED AND DEEMED ACCEPTABLE AS THE TIP SIZE CAN BE EXPELLED FROM THOSE AREAS NATURALLY WITHOUT ANY HARM TO THE PATIENT.THIS EVENT IS BEING REPORTED AS A DEVICE MALFUNCTION GIVEN THAT THE INJURY REPORTED DID NOT MEET THE CRITERIA FOR A SERIOUS INJURY PER 21 CFR 803 BUT THE EVENT AS REPORTED REASONABLY SUGGESTS THAT THE DEVICE MALFUNCTIONED AND THAT THE DEVICE OR A SIMILAR DEVICE MARKETED BY THE MANUFACTURER COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR DEPENDING ON THE LOCATION OF THE MALFUNCTION AND OTHER CONTRIBUTING FACTORS.THE DEVICE HISTORY RECORD FOR BSC15361 FROM JUNE 2021 (MO 15361) WAS REVIEWED AND THE LOT PASSED ALL TESTING. NOTHING OUT OF THE ORDINARY WAS NOTED. DURING PRODUCTION WHEN THE LOAD RETURNED FROM THE STERILIZER 3 CARTONS WERE NOTED TO HAVE INCURRED SOME DAMAGE AT THE STERILIZER OR IN TRANSIT BY THE SHIPPER. MANUFACTURING PERFORMED 100% SORT ON THE ENTIRE LOAD TO IDENTIFY ANY OTHER NON-CONFORMING PRODUCT. THE DISCREPANT PROBE CARTONS WERE REPACKAGED INTO NEW CARTONS IF THE PROBE STERILE POUCH BARRIER WAS INTACT AND IF THERE WAS NO DAMAGE NOTED TO THE PROBES AS A RESULT. NO ADVERSE EFFECT ON THE PRODUCT AS A RESULT. THE RISK ASSOCIATED TO THE TIP FALLING OFF FOR INDICATED USES HAS BEEN EVALUATED PER NOR-DOC-DRA-0025 REV O LINE 7.2.12 AND HAS BEEN DETERMINED TO BE LOW-RISK TO THE PATIENT AND/OR USER. THIS IS THE SECOND OCCURRENCE THAT NTI IS AWARE OF A TIP BEING EXPELLED DURING OFF-LABEL USE OF THE PROBE IN THE PANCREATIC DUCT WHICH COULD RESULT IN AN INCREASED RISK TO THE PATIENT. THIS TYPE OF USE WILL BE TRENDED, AND THE RISK ANALYSIS MAY BE UPDATED IF WARRANTED. THE UNIT HAS BEEN NOT RETURNED FOR NTI EVALUATION AND IS NOT EXPECTED TO RETURN.IF FURTHER INFORMATION WAS TO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2021 NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF THE ALLEGED EVENT FROM DISTRIBUTOR BOSTON SCIENTIFIC CORPORATION," NO PATIENT COMPLICATIONS. WHILE FIRING THE PROBE THE DISTAL TIP BROCK OFF. (DR. (B)(6)) REMOVED THE PROBE BUT WAS UNABLE TO RETRIEVE THE BROKEN PIECE. HE DECIDED TO TRY A NEW PROBE TO COMPLETE THE FRACTURING OF THE PANCREATIC STONE. WHAT TROUBLESHOOTING STEPS TOOK PLACE? THEY NEEDED TO REPLACE THE PROBE. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? WHAT IS THE NEXT COURSE OF ACTION? REPLACE DEFECTIVE DEVISE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1971675 AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC INTRA-CORPOREAL HYDRAULIC LITHOTRIPSY (IEHL) PROBE FFK NORTHGATE TECHNOLOGIES INC. 72-00322-0 BSC15361 00817183020448

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown