BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVELINQ ENDOAVF SYSTEM

    MDR report key: 11698641 · Received April 21, 2021

    Report

    Report Number
    9616666-2021-00048
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 25, 2021
    Report Date
    March 27, 2021
    Manufacturer
    CLEARSTREAM TECHNOLOGIES LTD.
    Product Code
    PQK
    UDI-DI
    00801741189104
    PMA / PMN Number
    K192239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. (EXPIRY DATE: 02/2022).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ARTERIOVENOUS FISTULA PROCEDURE, THE CATHETERS ALLEGEDLY DID NOT ACTIVATE. THEREFORE, A NEW SET OF CATHETERS WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598155 WAVELINQ ENDOAVF SYSTEM ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE PQK CLEARSTREAM TECHNOLOGIES LTD. WQ4300 CMEQ0227 00801741189104

    Patients

    Seq Age Sex Outcome Treatment
    1 Other