BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELINQ 4FR

    MDR report key: 11840406 · Received May 18, 2021

    Report

    Report Number
    9616666-2021-00077
    Event Type
    Injury
    Date Received
    May 18, 2021
    Date of Event
    March 26, 2021
    Report Date
    May 26, 2021
    Manufacturer
    CLEARSTREAM TECHNOLOGIES LTD.
    Product Code
    PQK
    UDI-DI
    00801741189104
    PMA / PMN Number
    K192239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A LOT HISTORY REVIEW, A DEVICE HISTORY RECORD REVIEW AND COMPLETE MANUFACTURING REVIEW COULD NOT BE CONDUCTED FOR THE INVESTIGATION AS THE LOT NUMBER IS UNKNOWN. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE RESULT OF THE INVESTIGATION IS CONFIRMED FOR THE REPORTED VESSEL SPASM OF THE LATERAL BRACHIAL VEIN ISSUE. HOWEVER THERE WAS NO REPORTED DEVICE MALFUNCTION. IT WAS OUTLINED WITHIN THE COMMUNICATIONS THAT THE REPORTED VESSEL SPASM OF THE LATERAL BRACHIAL VEIN WAS NOT RELATED TO THE DEVICE AND WAS DEFINITELY RELATED TO THE PROCEDURE. THEREFORE THE ROOT CAUSE FOR THE REPORTED ISSUE WAS RELATED TO THE PROCEDURE. LABELING REVIEW: THE INSTRUCTIONS FOR USE FOR THE WAVELINQ ENDOAVF SYSTEM WAS REVIEWED AND CONTAINS THE FOLLOWING INFORMATION RELEVANT TO THE REPORTED EVENT: PRECAUTIONS: 4. IF THE DEVICE DOES NOT PERFORM PROPERLY DURING THE CREATION OF THE ENDOVASCULAR FISTULA IT IS POSSIBLE THAT A FISTULA WILL NOT BE CREATED OR THERE MAY BE SOME VESSEL INJURY. POTENTIAL ADVERSE EVENTS: VESSEL, NERVE, OR AVF DAMAGE. EQUIPMENT SETUP: 3. PATIENT PREPARATION AND STERILE PRECAUTIONS SHOULD BE THE SAME AS FOR ANY PERCUTANEOUS TRANSCATHETER PROCEDURE. THE MEDICATION IS DECIDED BY THE PHYSICIAN, INCLUDING ANESTHESIA AND PRECAUTIONS TO REDUCE PAIN, CLOTTING, AND VASOSPASM DURING THE PROCEDURE ACCORDING TO LATEST SCIENTIFIC GUIDELINES AND WITH RESPECT TO THE INDIVIDUAL PATIENT. H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, POST DEVICE IMPLANTATION VESSEL SPASM OF LATERAL BRACHIAL VEIN WAS REPORTED. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, POST DEVICE IMPLANTATION VESSEL SPASM OF LATERAL BRACHIAL VEIN WAS REPORTED. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736281 WAVELINQ 4FR ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE PQK CLEARSTREAM TECHNOLOGIES LTD. WQ4300 UNKNOWN 00801741189104

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention