BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDE CATHETER

    MDR report key: 10344932 · Received July 30, 2020

    Report

    Report Number
    3008264254-2020-00003
    Event Type
    Injury
    Date Received
    July 30, 2020
    Date of Event
    March 31, 2017
    Report Date
    July 8, 2020
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    DQY
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. CERENOVUS MANUFACTURER'S REPORT NUMBERS: 3008264254-2020-00002 AND 3008264254-2020-00003 ARE RELATED TO THE SAME INCIDENT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED ¿OPTIMAL GUIDING CATHETER LENGTH FOR ENDOVASCULAR COILING OF INTRACRANIAL ANEURYSMS IN ANTERIOR CIRCULATION IN ERA OF FLOURISHING DISTAL ACCESS SYSTEM¿. 9 PATIENTS WITH ANTERIOR CIRCULATION ANEURYSMS WHO UNDERWENT ANEURYSMS EMBOLIZATION WITH GUIDING CATHETER ENVOY EXPERIENCED ARTERIAL SPASM DUE TO THE GUIDING CATHETER TIP DISPLACEMENT DURING THE PROCEDURE, AS A RESULT, THE CATHETERS WERE WITHDRAWAL. PURPOSE: TO DETERMINE THE MINIMUM REQUIRED GUIDING CATHETER LENGTH FOR EMBOLIZATION OF VARIOUS INTRACRANIAL ANEURYSMS IN ANTERIOR CIRCULATION AND TO ANALYZE THE EFFECT OF VARIOUS PATIENT FACTORS ON THE REQUIRED CATHETER LENGTH AND POTENTIAL INTERACTION WITH ITS STABILITY. MATERIALS AND METHODS: FROM DECEMBER 2016 TO MARCH 2017, 90 PATIENTS WITH 93 ANTERIOR CIRCULATION ANEURYSMS WERE ENROLLED. THREE TYPES OF GUIDING CATHETERS (ENVOY, ENVOY DA, AND ENVOY DA XB; CODMAN NEUROVASCULAR, RAYNHAM, MA, USA) WERE USED. WE MEASURED THE IN-THE-BODY LENGTH OF THE CATHETER AND CHECKED THE CATHETER TIP LOCATION IN THE CAROTID ARTERY. WE ANALYZED FACTORS AFFECTING THE IN-THE-BODY LENGTH AND STABILITY OF THE GUIDING CATHETER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812345 GUIDE CATHETER PERCUTANEOUS CATHETER DQY CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other