BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BNX

    MDR report key: 8701877 · Received June 14, 2019

    Report

    Report Number
    3004904811-2019-00023
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    December 23, 2015
    Report Date
    June 14, 2019
    Manufacturer
    COVIDIEN LP BARRX
    Product Code
    FCG
    UDI-DI
    00855208005018
    PMA / PMN Number
    K103668
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: RANDOMIZED NON-INFERIORITY TRIAL COMPARING DIAGNOSTIC YIELD OF CYTOPATHOLOGIST-GUIDED VERSUS SEVEN PASSES FOR ENDOSCOPIC ULTR ASOUND-GUIDED FINE-NEEDLE ASPIRATION OF PANCREATIC MASSES SOURCE: DIGESTIVE ENDOSCOPY 2016; 28: 469¿475; LINDA S. LEE, DIVISION OF GASTROENTEROLOGY, RECEIVED 27 OCTOBER 2015; ACCEPTED 16 DECEMBER 2015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. [(B)(4)].

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THIS WAS STUDY REGARDING A COMPARISON BETWEEN 2 METHODS OF USING THE ASPIRATION NEEDLE. THERE WERE FINDINGS OF COMPLICATIONS ON BOTH METHODS. POST STUDY REVEALED THAT THERE WERE 5 COMPLICATIONS IN THE CYTOPATHOLOGIST -GUIDED ARM WHICH INCLUDED THREE ACUTE PANCREATITIS WHEREIN ONE PATIENT HAD UNDERGONE AN ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY AT THE SAME TIME OBTAINING ADEQUATE ASPIRATE OF SOLID MASS (PANCREATIC) USING EUS. THERE WAS ONE PATIENT THAT FELL DURING THE RECOVERY PERIOD, BUT WITHOUT ASSOCIATED INJURIES. THE LAST PATIENT HAD A BROKEN NEEDLE REQUIRING REMOVAL OF THE ECHOENDOSCOPE. BASED FROM THE SEVEN-PASSES THERE WERE THREE COMPLICATIONS WHICH INCLUDED TO ONE PATIENT EXPERIENCING AN INTRAPROCEDURE BRADYCARDIA THAT WAS RESPONDED WITH ATROPINE. ANOTHER PATIENT EXPERIENCED A RESPIRATORY DISTRESS LEADING TO THE PROCEDURE BEING ABORTED. THE LAST PATIENT DEVELOPED ABDOMINAL PAIN AND FEVER (NORMAL LABORATORY STUDIES AND ABDOMINAL COMPUTED TOMOGRAPHY) THAT EVENTUALLY RESOLVED SPONTANEOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493437 BNX KIT, NEEDLE, BIOPSY FCG COVIDIEN LP BARRX DSN-22-01 00855208005018

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R