BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVELINQ ENDOAVF SYSTEM

    MDR report key: 11944825 · Received June 7, 2021

    Report

    Report Number
    9616666-2021-00090
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 17, 2021
    Report Date
    August 16, 2021
    Manufacturer
    CLEARSTREAM TECHNOLOGIES LTD.
    Product Code
    PQK
    UDI-DI
    00801741189104
    PMA / PMN Number
    K192239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A COMPLAINT HISTORY REVIEW WAS PERFORMED. THIS IS THE FIRST COMPLAINT REPORTED FOR THIS PRODUCT/LOT NUMBER COMBINATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND THE LOT MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION. THE RESULT OF THE INVESTIGATION IS UNCONFIRMED FOR THE REPORTED FAILURE TO CUT AND ACTIVATION ISSUES. THE SAMPLE ACTIVATED AND CUT THROUGH THE TISSUE SUCCESSFULLY DURING THE EVALUATION. THE DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE TO CUT AND ACTIVATION ISSUES COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. LABELING REVIEW: THE INSTRUCTION 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. EQUIPMENT SETUP 2. THE PROCEDURE SHOULD BE PERFORMED IN AN ANGIOGRAPHY ROOM AND CARRIED OUT UNDER X-RAY CONTROL. 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. 4. PLACE ESU ON A FLAT SECURE SURFACE LOCATED NEAR OPERATIVE FIELD MAKING SURE THAT THE GROUND PAD AND ELECTROSURGICAL PENCIL CABLING HAVE SUFFICIENT LENGTH TO BE CONNECTED DURING SUBSEQUENT PROCEDURAL STEPS. 5. TURN ON ESU. ENSURE THE CUT T MODE IS ILLUMINATED, THE POWER SETTING LED DISPLAY READS 60 W, AND THE MAXIMUM ACTIVATION TIME OF 0.7 SEC IS SET IN THE TIME LED DISPLAY. 6. PLACE GROUND PAD ON PATIENT FOLLOWING STANDARD GUIDELINES FOR ELECTROSURGICAL PATIENT GROUNDING AND INSERT GROUND PAD PLUG INTO ESU. CONFIRM INDICATOR LIGHT CHANGES FROM RED TO GREEN ENSURING APPROPRIATE PATIENT CONTACT. PRECAUTIONS: 3. CARE SHOULD BE TAKEN TO AVOID ATTEMPTING FISTULA CREATION IN A HEAVILY CALCIFIED LOCATION OF A VESSEL AS FISTULA MAY NOT BE ADEQUATELY FORMED. 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. 5. KEEP MAGNETIC ENDS OF CATHETERS AWAY FROM OTHER METALLIC OBJECTS WHICH MAY BECOME ATTRACTED AND COLLIDE WITH DEVICES. AVF CREATION: 33. ROTATE THE FLUOROSCOPE TO VISUALIZE THE MAXIMUM TISSUE THICKNESS DISTANCE BETWEEN ARTERIAL AND VENOUS CATHETERS. CONFIRM THAT THE TISSUE THICKNESS ADJACENT TO THE ELECTRODE HOUSING IS NO GREATER THAN THE WIDTH OF THE MAGNET ARRAY WHICH IS 1MM. IF TISSUE THICKNESS APPEARS GREATER, ADJUST CATHETER POSITION TO A THINNER TISSUE SEGMENT. 34. WITH CATHETERS IN CONFIRMED ACTIVATION POSITION, REMOVE CABLE TIE AND CONNECT VENOUS CATHETER PLUG PIN TO ELECTROSURGICAL PENCIL AFTER REMOVING PRE-ASSEMBLED INSERT. FULLY INSERT THE VENOUS CATHETER PLUG PIN UNTIL THERE IS NO METALLIC SURFACE EXPOSED. 35. PASS THE ELECTROSURGICAL PENCIL AND 3 PRONG UNIVERSAL CONNECTOR OUT OF THE STERILE FIELD AND CONNECT IT TO ESU¿S MONOPOLAR 1 RECEIVER. 36. RETRACT OR REMOVE BOTH 0.014" GUIDEWIRES FROM THE CATHETER ACTIVATION ZONE. NO GUIDEWIRES SHOULD BE PRESENT BETWEEN THE PROXIMAL AND DISTAL MAGNET ZONES DURING ACTIVATION. 37. ENSURE TOURNIQUET HAS BEEN REMOVED (IF APPLIED). 38. DO NOT ALLOW CATHETERS TO MOVE IN ORDER TO MINIMIZE CHANCE OF MISALIGNMENT. 39. USING FLUOROSCOPY, VERIFY FINAL CATHETER AND ELECTRODE POSITION BEFORE ENERGY DELIVERY. H10: D4 (EXPIRY DATE: 07/2022). 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 PROCEDURE THROUGH THE LEFT MEDIAL BRACHIAL VEIN, THE DEVICE WAS ADVANCED THROUGH THE BODY TO REACH THE TARGET SITE AND UPON REACHING THE SITE, THE MAGNETS ALLEGEDLY WOULD NOT COAPT. EXTERNAL COMPRESSION WAS APPLIED AND THE DEVICE WAS ACTIVATED. IT WAS FURTHER REPORTED THAT NO FISTULA WAS CREATED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRY DATE: 07/2022).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THROUGH THE LEFT MEDIAL BRACHIAL VEIN, THE DEVICE WAS ADVANCED THROUGH THE BODY TO REACH THE TARGET SITE AND UPON REACHING THE SITE, THE MAGNETS ALLEGEDLY WOULD NOT COAPT. EXTERNAL COMPRESSION WAS APPLIED AND THE DEVICE WAS ACTIVATED. IT WAS FURTHER REPORTED THAT NO FISTULA WAS CREATED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846697 WAVELINQ ENDOAVF SYSTEM ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE PQK CLEARSTREAM TECHNOLOGIES LTD. WQ4300 CMEV0079 00801741189104

    Patients

    Seq Age Sex Outcome Treatment
    1 Other