BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BEACON NEEDLE

    MDR report key: 17049937 · Received June 2, 2023

    Report

    Report Number
    3004904811-2023-00008
    Event Type
    Injury
    Date Received
    June 2, 2023
    Date of Event
    August 18, 2022
    Report Date
    June 2, 2023
    Manufacturer
    COVIDIEN LP BARRX
    Product Code
    NEU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: FINE-NEEDLE BIOPSY WITH 19G NEEDLE IS EFFECTIVE IN COMBINATION WITH ENDOSCOPIC ULTRASOUND-GUIDED TISSUE ACQUISITION FOR GENOMIC PROFILING OF UNRESECTABLE PANCREATIC CANCER SOURCE: DIGESTIVE ENDOSCOPY 2023; 35: 124¿133 ACCEPTED ON 18 AUGUST 2022. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE STUDY, A RETROSPECTIVE STUDY INVESTIGATED SUCCESS RATES IN PATIENTS WITH UNRESECTABLE PANCREATIC DUCTAL ADENOCARCINOMA UNDERGOING ENDOSCOPIC ULTRASOUND GUIDED TISSUE ACQUISITION BETWEEN JUNE 2019 AND DECEMBER 2021. THERE WERE 150 PATIENTS INCLUDED IN THE STUDY AND 118 FINE NEEDLE BIOPSY SAMPLES WERE OBTAINED USING A FORK TIP NEEDLE OR A COMPETITOR DEVICE. REPORTED COMPLICATIONS ASSOCIATED WITH FINE NEEDLE BIOPSY PROCEDURE INCLUDED SEVERE HEMORRHAGE IN ONE CASE AND MILD PANCREATITIS IN 5 CASES. THE ARTICLE DOES NOT SPECIFY WHICH DEVICE WAS ASSOCIATED WITH THE COMPLICATIONS REPORTED. THE AUTHOR DOES NOT MENTION ANY INTERVENTIONS IMPLEMENTED FOR THE SEVERE HEMORRHAGE OR MILD PANCREATITIS COMPLICATIONS THAT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371925 UNKNOWN BEACON NEEDLE MARKER, RADIOGRAPHIC, IMPLANTABLE NEU COVIDIEN LP BARRX UNKNOWN BEACON NEEDLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other