BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIODYNAMICS

    MDR report key: 8723209 · Received June 21, 2019

    Report

    Report Number
    1317056-2019-00081
    Event Type
    Death
    Date Received
    June 21, 2019
    Date of Event
    May 17, 2019
    Report Date
    August 14, 2019
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OEZ
    UDI-DI
    H965651413920
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    AS NO LOT NUMBER WAS PROVIDED, A SHIP HISTORY REPORT (SHR) WAS GENERATED FOR ITEM NUMBER (H965651413921) IN ORDER TO DETERMINE THE LAST THREE LOTS SHIPPED TO THE REPORTING HOSPITAL IN THE SIX MONTHS PRIOR TO THE PROCEDURE DATE. THE THREE LOTS OBTAINED THROUGH THE SHR WERE (5446617, 5461557 AND 5466407). THE DEVICE HISTORY RECORDS FOR THE LOTS OBTAINED THROUGH THE SHIP HISTORY REPORT WERE REVIEWED FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE JUNE 2019 FLUID MANAGEMENT COMPLAINT REPORT WAS REVIEWED FOR THE CONVENIENCE KIT PRODUCT FAMILY AND THE FAILURE MODE "DEVICE - AIR BUBBLES. " NO ADVERSE TREND WAS IDENTIFIED. THE HOSPITAL'S REPORTED COMPLAINT DESCRIPTION CANNOT BE CONFIRMED AS NO SAMPLE WAS RETURNED FOR EVALUATION. IN ADDITION, ANGIODYNAMICS ASKED FOR CLARIFYING INFORMATION REGARDING IF AIR WAS INJECTED INTO THE PATIENT AND WHAT WAS THE CAUSE OF THE PATIENT'S EXPIRATION. NO RESPONSE RECEIVED AFTER MULTIPLE, DOCUMENTED, REQUESTS FOR THIS INFORMATION. WITHOUT RECEIVING PRODUCT FOR EVALUATION OR ADDITIONAL INFORMATION, WE ARE UNABLE TO DEFINITIVELY DETERMINE A ROOT CAUSE FOR THIS INCIDENT. A POSSIBLE ROOT CAUSE MAY BE THAT THE END USER DID NOT ADEQUATELY SECURE DEVICE CONNECTIONS. THE DIRECTIONS FOR USE PACKAGED WITH THE CONVENIENCE KIT CONTAINS THE FOLLOWING STATEMENTS, "ALL CONNECTIONS SHOULD BE FINGER TIGHTENED. OVER TIGHTENING CAN CAUSE CRACKS AND LEAKS TO OCCUR THAT COULD RESULT IN EMBOLISM AND OR EXPOSURE TO BIOHAZARDS." CORRECTION/CORRECTIVE ACTIONS: NO CORRECTION IS REQUIRED SINCE NO SAMPLE WAS RETURNED FOR EVALUATION AND A ROOT CAUSE FOR THIS EVENT IS INCONCLUSIVE. BASED ON NO ISSUES NOTED IN THE DHR, AND ADEQUATE PROCESS CONTROLS IN PLACE, NO CORRECTIVE ACTION TO BE TAKEN BY ANGIODYNAMICS AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    ANGIODYNAMICS IS CONTINUING IN ITS ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT FROM THE END USER HOSPITAL, SPECIFICALLY THE RELATIONSHIP (IF ANY) BETWEEN THE REPORTED DEVICE AND THE PATIENT'S CAUSE OF DEATH. A SUPPLEMENTAL MEDWATCH WILL BE FILED CONTAINING THE ADDITIONAL INFORMATION WHEN IT IS OBTAINED. ((B)(4)).

    Description of Event or Problem · 1

    AS REPORTED BY CATH LAB MANAGER, ONE OF THE HOSPITAL'S PHYSICIANS INJECTED AN AIR BUBBLE INTO A PATIENT ON (B)(6) 2019 DURING A CASE. AN AIR BUBBLE HAD BEEN OBSERVED IN THE SYRINGE NEAR THE PLUNGER. THE PATIENT WAS HAVING THE PROCEDURE DUE TO AN "EMERGENT STEMI CASE" AND PASSED AWAY DURING THE PROCEDURE. THE CAUSE OF DEATH AND RELATIONSHIP TO THIS EVENT (IF ANY) HAS NOT BEEN PROVIDED TO ANGIODYNAMICS YET. ANGIODYNAMICS HAS MADE MULTIPLE ATTEMPTS TO CONTACT PERSONNEL AT THE HOSPITAL, BUT THEY HAVE, AS OF YET, BEEN UNAVAILABLE. THE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ARE CONTINUING. THE PRODUCTS USED DURING THE PROCEDURE HAVE BEEN DISPOSED OF AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516368 ANGIODYNAMICS CONVENIENCE KIT OEZ ANGIODYNAMICS H965651413920

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death