BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXODUS DRAINAGE CATHETER

    MDR report key: 13549900 · Received February 17, 2022

    Report

    Report Number
    1317056-2022-00038
    Event Type
    Malfunction
    Date Received
    February 17, 2022
    Date of Event
    February 1, 2022
    Report Date
    February 17, 2022
    Manufacturer
    ANGIODYNAMICS
    Product Code
    FGE
    PMA / PMN Number
    K152069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE REPORTED DEVICE WAS NOT RETURNED, ANGIODYNAMICS IS UNABLE TO PERFORM A DEVICE EVALUATION. THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF (HUB CRACKED) CANNOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT RECEIVING PRODUCT FOR EVALUATION, WE ARE UNABLE TO DEFINITIVELY DETERMINE A ROOT CAUSE FOR THIS INCIDENT. CONTRACT MANUFACTURER (B)(4) OF THE EXODUS DC DEVICE WAS MADE AWARE OF THIS EVENT VIA FYI (B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT CONDUCTED SINCE THERE WAS NO REPORTED DEVICE LOT NUMBER. SHIP HISTORY REPORT (SHR) FOR PAST 12 MONTHS SHOWS CUSTOMER PURCHASES MULTIPLE UPNS OF EXODUS MULTI-PURPOSE DRAINAGE CATHETERS BUT ONLY SINCE AUG-2021; THEY ARE TOTAL ABSCESSION (TA) DRAINAGE CATHETER USERS AND SWITCHED TEMPORARILY TO EXODUS DUE TO TA BACK ORDER. A DHR REVIEW OF THE SHR LOTS IS NOT WARRANTED AS UPNS ARE UNKNOWN. LABELING REVIEW: THE INSTRUCTIONS FOR USE WHICH IS SUPPLIED TO THE END USER WITH THIS CATALOG NUMBER STATES, "WARNINGS: DO NOT USE THIS CATHETER WITH ALCOHOL. PLACING A 10 FRENCH OR LARGER CATHETER AS THE PRIMARY DRAIN BEFORE FORMATION OF A TRACT MAY BE DIFFICULT IN SOME PATIENTS. IN THESE PATIENTS, THE INITIAL BILIARY DRAINAGE SHOULD BE STARTED WITH A SMALLER (8 FRENCH) CATHETER UNTIL A SUITABLE TRACT ALLOWS PLACEMENT OF A LARGER CATHETER. WHERE LONG-TERM USE IS INDICATED, IT IS RECOMMENDED THAT INDWELLING TIME NOT EXCEED 90 DAYS. THIS CATHETER SHOULD BE EVALUATED BY THE PHYSICIAN ON OR BEFORE 90 DAYS POST PLACEMENT." LABELING REVIEW: DIRECTIONS FOR USE (DFU) STATES THE FOLLOWING: CAUTION: ALL CONNECTIONS MUST BE SECURE AND AIRTIGHT. PERFORM INSPECTIONS OF THE CATHETER AND CONNECTIONS REGULARLY. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. REFERENCE (B)(4). REFERENCE REPORTS: DEVICE 1: (B)(4), 1317056-2022-00037, DEVICE 3: (B)(4), 1317056-2022-00039, DEVICE 4: (B)(4), 1317056-2022-00040, DEVICE 5: (B)(4), 1317056-2022-00041, DEVICE 6: (B)(4), 1317056-2022-00047, DEVICE 7: (B)(4), 1317056-2022-00048, DEVICE 8: (B)(4), 1317056-2022-00049.

    Description of Event or Problem · 0

    DEVICE 2 OF 8: AN END USER REPORTED AN ISSUE WITH 8 SEPARATE EXODUS DRAINAGE CATHETERS THAT HAVE EXPERIENCED HUB CRACKS. THE DEVICES REQUIRED REMOVAL. ADDITIONAL INFORMATION PROVIDED REPORTED THE CATHETERS WERE REPLACED WITH A DIFFERENT DRAIN BRAND. THERE WAS NO REPORT OF THE PATIENT EXPERIENCING ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860935 EXODUS DRAINAGE CATHETER BILIARY (GENERAL) (NEPHOSTROMY) DRAINAGE CATHETER FGE ANGIODYNAMICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown