BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRA-CORPOREAL HYDRAULIC LITHOTRIPSY (IEHL) PROBE

    MDR report key: 11033251 · Received December 17, 2020

    Report

    Report Number
    0001450997-2020-00009
    Event Type
    Injury
    Date Received
    December 17, 2020
    Date of Event
    October 26, 2020
    Report Date
    December 16, 2020
    Manufacturer
    NORTHGATE TECHNOLOGIES INC.
    Product Code
    FFK
    PMA / PMN Number
    K130368
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NORTHGATE TECHNOLOGIES RECEIVED NOTIFICATION FROM CUSTOMER BOSTON SCIENTIFIC ON OCTOBER 30, 2020 OF THE ALLEGED EVENT. NORTHGATE ATTEMPTED TO OBTAIN FURTHER INFORMATION ABOUT THE CAUSALITY OF THE EVENT FROM THE DEVICE IN QUESTION. ON 12/17 FURTHER REQUESTS FOR INFORMATION WENT UNANSWERED, THEREFORE NTI MADE THE DETERMINATION TO SUBMIT WITH THE INFORMATION AVAILABLE. EVEN THOUGH THE SPECIFIC PART NUMBER OF THE PROBE IN THIS REPORT IS UNKNOWN THE (B)(4) RISK ANALYSIS FOR AUTOLITH TOUCH/URO-TOUCH/BSC AUTOLITH TOUCH & ASSOCIATED EHL DISPOSABLE PROBES WAS REVIEWED, AS THIS IS LIKELY AN AUTOLITH TOUCH PROBE. SECTION 7.4.12 REFERS TO THE RISK OF POST-OPERATIVE COMPLICATION DUE TO PATIENT INJURY FROM BLEEDING. THE OPERATORS MANUAL CONTAINS A WARNING REGARDING BLEEDING. THE RISK OF DEATH OR SERIOUS INJURY FROM THE STATED ISSUE IS REMOTE. ITEMS 7.1.11(A) AND (B) REFERS TO THE RISK OF PERFORATION OF THE BILIARY DUCTAL SYSTEM THE OPERATORS MANUAL CONTAINS A WARNING THAT THE DEVICE SHOULD BE OPERATED BY EXPERIENCED PEOPLE AND TO NOT PLACE THE PROBE AGAINST TISSUE. A CLINICAL EVALUATION WAS PERFORMED PER (B)(4) WHICH PROVED THE BENEFITS OF LITHOTRIPSY OUTWEIGH THE RISKS. THE RISK OF DEATH OR SERIOUS INJURY FROM THE STATED ISSUE IS REMOTE. THIS IS THE FIRST REPORT OF HEPATIC INJURY AFTER USE OF AN AUTOLITH PROBE, AND/OR DEVICE. A FOLLOW UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    NORTHGATE TECHNOLOGIES WAS MADE AWARE OF THE FOLLOWING EVENT "THE ERCP + SPYGLASS PROCEDURE WAS PERFORMED ON MONDAY (B)(6) 2020, AT CLINICA LA COSTA. THE PATIENT WAS OPERATED AS SHE HAD A CHOLEDOCHOLITHIASIS AND THE STONE WAS FRAGMENTED WITH ELECTROHYDRAULIC ENERGY (EHL). AN AUTOLITH PROBE WAS USED AT A POWER OF 5 MEDIUM WITH A TOTAL OF 750 SHOTS. THE PROCEDURE WAS PERFORMED SUCCESSFULLY, THERE WERE NO COMPLICATIONS REPORTED FOR THE PATIENT AND SHE WAS DISCHARGED AFTER THE PROCEDURE. 24 HOURS LATER, THE PATIENT ARRIVED AT THE EMERGENCY DEPARTMENT DUE TO ABDOMINAL PAIN, SHE WAS ADMITTED ON WEDNESDAY (B)(6) 2020 FOR OPEN SURGERY IN WHICH IT WAS FOUND A LIVER INJURY, VISUALIZING AN HEPATIC RUPTURE AND PROFUSE HEMORRHAGE. THE PATIENT WAS HOSPITALIZED IN THE ICU SERVICE DUE TO THE COMPLEXITY OF THE CASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497257 INTRA-CORPOREAL HYDRAULIC LITHOTRIPSY (IEHL) PROBE FFK NORTHGATE TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization