BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC

    MDR report key: 14685262 · Received June 14, 2022

    Report

    Report Number
    0001450997-2022-00007
    Event Type
    Injury
    Date Received
    June 14, 2022
    Date of Event
    April 21, 2022
    Report Date
    June 13, 2022
    Manufacturer
    NORTHGATE TECHNOLOGIES INC.
    Product Code
    FFK
    UDI-DI
    00817183020448
    PMA / PMN Number
    K130368
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(4) 2022, NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF AN ALLEGED EVENT FROM DISTRIBUTOR BOSTON SCIENTIFIC CORPORATION." IT WAS REPORTED THAT: THE SUBJECT UNDERWENT THE STUDY PROCEDURE ON (B)(4) 2022. SPYGLASS DISCOVER DIGITAL CATHETER: (B)(4). NO ADDITIONAL SPYGLASS CATHETER WAS USED IN THE PROCEDURE - SPYGLASS DISCOVER CATHETER WAS ADVANCED TO TARGET; TARGET LESION OR STONES WERE VISUALIZED AND A GUIDEWIRE WAS USED TO ADVANCE THE SPYGLASS DISCOVER DURING PTCS. DIAMETER OF LAST CATHETER USED PRIOR TO ADVANCING THE SPYGLASS DISCOVER (11 FR) PTCS PROCEDURAL MANEUVERS: CLEARANCE OF BILIARY STONE(S)/SLUDGE, WITH LITHOTRIPSY: MECHANICAL, ELECTROHYDRAULIC OR LASER: ATTEMPTED AND COMPLETED (BSC DEVICE); INTRADUCTAL DRAIN REMAINED IN PLACE FOR PATIENT SAFETY (10FR); NO, INTRAPERITONEAL DRAIN WAS PLACED AT THE END OF THE PROCEDURE. THE SUBJECT EXPERIENCED THE FOLLOWING EVENTS: ONSET DATE: (B)(46 2022 - ONSET LATENCY: 1 DAYS; EVENT: SEPSIS (EVENT ID 1) SEVERITY: MODERATE; SERIOUS CRITERIA: HOSPITALIZED; ACTION TAKEN: HOSPITAL, DRUG THERAPY (ANTIBIOTICS - TAZOCIN) OUTCOME: ONGOING; DEVICE RELATIONSHIP: PROBABLE (SPYGLASS DISCOVER DIGITAL CATHETER); PANCREATICOBILIARY DUCTAL ACCESS PORTION OF THE PTCS PROCEDURE RELATIONSHIP: PROBABLE; CHOLANGIOPANCREATOSCOPY PORTION OF THE PTCS PROCEDURE RELATIONSHIP: PROBABLE; ACCESSORY DEVICE USED THROUGH THE WORKING CHANNEL OF THE SPYGLASS? DISCOVER DIGITAL CATHETER: POSSIBLE (AUTOLITH); DEVICE DEFICIENCY COULD HAVE LED TO SAE: N/A INITIAL EMAIL NOTIFICATION FROM THE INVESTIGATOR STATED: SUBJECT HAD FEVER WITH HIGH ELEVATION OF INFLAMMATORY MARKERS (PCR, PCT AND WBC). ANTIBIOTICS TAZOCIN WAS STARTED IN RESPONSE. QUERY POSTED: LOT NUMBER FOR THE BSC ELECTROHYDRAULIC LITHOTRIPSY (AUTOLITH) DEVICE 2 OF 2 DEVICE/PROCEDURE OUTCOME: PROCEDURE. NO INFORMATION AVAILABLE,DEVICE (B)(4). FEVER COUNTRY OF EVENT: ITALY". THERE WAS NO ALLEGED DEVICE MALFUNCTION DURING THE EHL PROCEDURE. ADDITIONAL QUESTIONS WERE SEND TO THE CUSTOMER ON (B)(6) 2022. AS OF (B)(6) 2022, WE HAVE NOT RECEIVED ANY ADDITIONAL INFORMATION DESPITE MULTIPLE REQUESTS FROM THE END USER; THE DISTRIBUTOR INDICATED ON (B)(6) 2022 "NO RESPONSE HAS BEEN RECEIVED". A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER OF THE DEVICE IS UNKNOWN. CAPA (B)(4) WAS INITIATED TO INVESTIGATE THE EVENT WITH THE AVAILABLE INFORMATION FROM THE USER FACILITY. THE SUSPECT DEVICE WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. THE PROBE HAS NOT BEEN RETURNED FOR EVALUATION. THE INITIAL REPORT INDICATED CAUSALITY IS GENERAL AND STATES THAT THE RELATIONSHIP BETWEEN THE PROCEDURE AND THE SEPSIS IS "PROBABLE" BUT PROVIDED NO FURTHER DETAIL. ADDITIONALLY, A REVIEW OF IN-PROCESS PULL TEST DATA ON SEAL TESTS FOR A YEAR AND STERILIZER DOCUMENTATION WAS ALSO REVIEWED AS A PART OF CAPA INVESTIGATION WITH NO FAILURES NOTED. THE ROOT CAUSE IS UNABLE TO BE DETERMINED WITH THE AVAILABLE INFORMATION. A FOLLOW UP REPORT WILL BE FILED WITH ANY ADDITIONAL INFORMATION AND FINDINGS, IF WERE TO BECOME AVAILABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF AN ALLEGED EVENT FROM DISTRIBUTOR BOSTON SCIENTIFIC CORPORATION." IT WAS REPORTED THAT: THE SUBJECT UNDERWENT THE STUDY PROCEDURE ON (B)(6) 2022. SPYGLASS DISCOVER DIGITAL CATHETER: (B)(4). NO ADDITIONAL SPYGLASS CATHETER WAS USED IN THE PROCEDURE SPYGLASS DISCOVER CATHETER WAS ADVANCED TO TARGET; TARGET LESION OR STONES WERE VISUALIZED AND A GUIDEWIRE WAS USED TO ADVANCE THE SPYGLASS DISCOVER DURING PTCS. DIAMETER OF LAST CATHETER USED PRIOR TO ADVANCING THE SPYGLASS DISCOVER (11 FR) PTCS PROCEDURAL MANEUVERS: - CLEARANCE OF BILIARY STONE(S)/SLUDGE, WITH LITHOTRIPSY: MECHANICAL, ELECTROHYDRAULIC OR LASER: ATTEMPTED AND COMPLETED (BSC DEVICE); INTRADUCTAL DRAIN REMAINED IN PLACE FOR PATIENT SAFETY (10FR) NO, INTRAPERITONEAL DRAIN WAS PLACED AT THE END OF THE PROCEDURE. THE SUBJECT EXPERIENCED THE FOLLOWING EVENTS: ONSET DATE: (B)(6) 2022. ONSET LATENCY: 1 DAYS; EVENT: SEPSIS (EVENT ID 1) SEVERITY: MODERATE; SERIOUS CRITERIA: HOSPITALIZED; ACTION TAKEN: HOSPITAL, DRUG THERAPY (ANTIBIOTICS - TAZOCIN) ; OUTCOME: ONGOING; DEVICE RELATIONSHIP: PROBABLE (SPYGLASS DISCOVER DIGITAL CATHETER) PANCREATICOBILIARY DUCTAL ACCESS PORTION OF THE PTCS PROCEDURE RELATIONSHIP: PROBABLE. CHOLANGIOPANCREATOSCOPY PORTION OF THE PTCS PROCEDURE RELATIONSHIP: PROBABLE - ACCESSORY DEVICE USED THROUGH THE WORKING CHANNEL OF THE SPYGLASS? DISCOVER DIGITAL CATHETER: POSSIBLE (AUTOLITH) DEVICE DEFICIENCY COULD HAVE LED TO SAE: N/A INITIAL EMAIL NOTIFICATION FROM THE INVESTIGATOR STATED: SUBJECT HAD FEVER WITH HIGH ELEVATION OF INFLAMMATORY MARKERS (PCR, PCT AND WBC). ANTIBIOTICS TAZOCIN WAS STARTED IN RESPONSE. QUERY POSTED: LOT NUMBER FOR THE BSC ELECTROHYDRAULIC LITHOTRIPSY (AUTOLITH) DEVICE 2 OF 2 DEVICE/PROCEDURE OUTCOME: PROCEDURE. NO INFORMATION AVAILABLE,DEVICE (B)(4). FEVER COUNTRY OF EVENT: ITALY". THERE WAS NO ALLEGED DEVICE MALFUNCTION DURING THE EHL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181033 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 Other| H