BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVELINQ ENDOAVF SYSTEM

    MDR report key: 11736175 · Received April 28, 2021

    Report

    Report Number
    9616666-2021-00058
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    April 1, 2021
    Report Date
    May 13, 2021
    Manufacturer
    CLEARSTREAM TECHNOLOGIES LTD.
    Product Code
    PQK
    UDI-DI
    00801741189104
    PMA / PMN Number
    K192239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. INVESTIGATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION. THE RESULT OF THE INVESTIGATION IS CONFIRMED FOR THE REPORTED MATERIAL DEFORMATION ISSUE. THE ELECTRODE WAS DEFORMED AND FLATTENED. THE INVESTIGATION IS UNCONFIRMED FOR THE REPORTED SEPARATION ISSUE AS THE DEVICE WAS FULLY INTACT AND THE ELECTRODE WAS SEATED WITHIN ITS HOUSING. THERE WAS BLOOD OBSERVED ON THE MAGNETS AND IN/ON THE ELECTRODE HOUSING. A 0.014" GUIDEWIRE PASSED SUCCESSFULLY THROUGH THE TIP AND THERE WAS SOME YELLOW BODILY SUBSTANCE REMOVED FROM WITHIN THE TIP. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION RECEIVED. LABELING REVIEW: THE INSTRUCTIONS FOR USE FOR THE WAVELINQ ENDOAVF SYSTEM WAS REVIEWED AND CONTAINS THE FOLLOWING INFORMATION RELEVANT TO THE REPORTED EVENT: CAUTIONS: 1. ONLY PHYSICIANS TRAINED AND EXPERIENCED IN ENDOVASCULAR TECHNIQUES, WHO HAVE RECEIVED APPROPRIATE TRAINING WITH THE DEVICE, SHOULD USE THE DEVICE. ENDOVASCULAR TECHNIQUE TRAINING AND EXPERIENCE SHOULD INCLUDE ULTRASOUND VESSEL ACCESS IN THE ARM, GUIDEWIRE NAVIGATION, RADIOGRAPHIC IMAGING, PLACEMENT OF VASCULAR EMBOLIZATION DEVICES (INCLUDING EMBOLIZATION COILS), AND ACCESS HEMOSTASIS. 2. ADHERE TO UNIVERSAL PRECAUTIONS WHEN UTILIZING THE DEVICE. 3. DO NOT KINK, PINCH, CUT, BEND, TWIST, OR PULL EXCESSIVELY OR WITH EXCESSIVE FORCE ON ANY PORTION OF THE DEVICES. DAMAGE TO THE CATHETER BODY MAY CAUSE THE DEVICE TO BECOME INOPERABLE. 4. AVOID SHARP BENDS. THIS MAY CAUSE THE DEVICE TO BECOME INOPERABLE. 5. DO NOT PINCH OR GRASP THE CATHETER WITH EXCESSIVE FORCE OR WITH OTHER INSTRUMENTS. THIS MAY CAUSE THE DEVICE TO BECOME INOPERABLE. 6. DO NOT BEND THE RIGID PORTION OF THE CATHETER NEAR THE ELECTRODE OR BACKSTOP. 7. DO NOT TOUCH OR HANDLE THE ACTIVE ELECTRODE. ELECTRODE DISLODGEMENT MAY OCCUR. 8. ALWAYS USE THE HEMOSTASIS VALVE CROSSER TO ASSIST INSERTION OF THE VENOUS CATHETER THROUGH THE INTRODUCER SHEATH. INSERTION INTO INTRODUCER SHEATH WITHOUT HEMOSTASIS VALVE CROSSER MAY DAMAGE ELECTRODE. WAVELINQ¿ ENDOAVF SYSTEM PROCEDURE: 31. ADVANCE THE VENOUS CATHETER OVER THE 0.014" WIRE UNTIL THE YELLOW HEMOSTASIS VALVE CROSSER ENCOUNTERS THE HEMOSTASIS VALVE OF THE INTRODUCER SHEATH. GRASP AND INSERT THE YELLOW HEMOSTASIS VALVE CROSSER THROUGH THE HEMOSTASIS VALVE UNTIL IT STOPS IN THE SHEATH HUB. GRASP THE PROXIMAL END OF THE YELLOW VALVE CROSSER AND ADVANCE THE CATHETER SIMULTANEOUSLY THROUGH THE YELLOW CROSSER AND THE SHEATH. FLUOROSCOPICALLY INSPECT THE ELECTRODE AFTER VENOUS CATHETER INSERTION TO CONFIRM PROPER ELECTRODE FORM. IF THE ELECTRODE APPEARS DEFORMED, GENTLY REMOVE VENOUS CATHETER AND INSPECT. IF UPON DIRECT VISUAL INSPECTION THE ELECTRODE APPEARS DAMAGED, REPLACE THE VENOUS CATHETER. IF VENOUS CATHETER IS REMOVED AND REQUIRES REINSERTION, REPOSITION THE YELLOW VALVE CROSSER OVER THE ELECTRODE PRIOR TO ADVANCING THROUGH THE HEMOSTASIS VALVE. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ENDOVASCULAR FISTULA (ENDOAVF) PROCEDURE, THE ELECTRODE WAS ALLEGEDLY DEFORMED. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD MATERIAL SEPARATION. THERE WAS NO REPORTED PATIENT INJURY.

    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 THAT DURING A ENDOVASCULAR FISTULA (ENDOAVF) PROCEDURE, THE ELECTRODE WAS ALLEGEDLY DEFORMED. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD MATERIAL SEPARATION. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632143 WAVELINQ ENDOAVF SYSTEM ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE PQK CLEARSTREAM TECHNOLOGIES LTD. WQ4300 UNKNOWN 00801741189104

    Patients

    Seq Age Sex Outcome Treatment
    1 Other