WAVELINQ 4FR P
Report
- Report Number
- 9616666-2026-00022
- Event Type
- Injury
- Date Received
- February 12, 2026
- Date of Event
- December 18, 2025
- Report Date
- February 23, 2026
- 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
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H11: 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. SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.
H11: MANUFACTURING REVIEW: A COMPLAINT HISTORY REVIEW WAS PERFORMED. THIS IS THE THIRTEENTH COMPLAINT REPORTED FOR THIS PRODUCT/LOT NUMBER COMBINATION. HOWEVER, THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: THE WAVELINQ DEVICE WAS NOT AVAILABLE FOR RETURN. HOWEVER, THE RESULT OF THE INVESTIGATION IS CONFIRMED FOR THE REPORTED PATIENT ADVERSE EVENTS OF STENOSIS AND FAILURE TO MATURE POST ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION. LABELING REVIEW: THE INSTRUCTION FOR USE OF THIS WAVELINQ WQ4300 DEVICE WAS REVIEWED AND THE FOLLOWING SECTIONS ARE APPLICABLE. INDICATIONS THE WAVELINQ ENDOAVF SYSTEM IS INDICATED FOR THE CREATION OF AN ARTERIOVENOUS FISTULA (AVF) USING CONCOMITANT ULNAR ARTERY AND ULNAR VEIN OR CONCOMITANT RADIAL ARTERY AND RADIAL VEIN IN PATIENTS WITH MINIMUM ARTERY AND VEIN DIAMETERS OF 2.0 MM AT THE FISTULA CREATION SITE WHO HAVE CHRONIC KIDNEY DISEASE AND NEED HEMODIALYSIS. CONTRAINDICATIONS TARGET VESSELS 2MM IN DIAMETER. WARNINGS 1. THE WAVELINQ ENDOAVF SYSTEM IS ONLY TO BE USED WITH THE APPROVED COMPONENTS SPECIFIED ABOVE. DO NOT ATTEMPT TO SUBSTITUTE NO APPROVED DEVICES OR USE ANY COMPONENT OF THIS SYSTEM WITH ANY OTHER MEDICAL DEVICE SYSTEM. USE OF THE SYSTEM WITH OTHER COMPONENTS MAY INTERFERE WITH PROPER FUNCTIONING OF THE DEVICE. 2. THE WAVELINQ CATHETERS ARE SINGLE USE DEVICES. DO NOT RESTERILIZE OR REUSE EITHER CATHETER. POTENTIAL HAZARDS OF REUSE INCLUDE INFECTION, DEVICE MECHANICAL FAILURE, OR ELECTRICAL FAILURE POTENTIALLY RESULTING IN SERIOUS INJURY OR DEATH. 3. THE WAVELINQ ENDOAVF SYSTEM SHOULD NOT BE USED IN PATIENTS WHO HAVE KNOWN CENTRAL VENOUS STENOSIS OR UPPER EXTREMITY VENOUS OCCLUSION ON THE SAME SIDE AS THE PLANNED AVF CREATION. 4. THE WAVELINQ ENDOAVF SYSTEM SHOULD NOT BE USED IN PATIENTS WHO HAVE A KNOWN ALLERGY OR REACTION TO ANY DRUGS/FLUIDS USED IN THIS PROCEDURE. 6. THE SAFETY AND PERFORMANCE OF THE DEVICE VIA ARTERIAL WRIST ACCESS HAVE NOT BEEN FULLY ESTABLISHED. THE INCIDENCE OF VESSEL STENOSIS OR OCCLUSION THAT OCCURS IN THE RADIAL AND ULNAR ARTERIES AFTER ARTERIAL WRIST ACCESS HAS NOT BEEN EVALUATED. 7. DO NOT USE THE DEVICE TO CREATE AN ENDOAVF USING ARTERIAL ACCESS VIA THE RADIAL OR ULNAR ARTERY. THE ENDOAVF SHOULD ONLY BE CREATED USING BRACHIAL ARTERY ACCESS. 15. DO NOT USE CLOSURE DEVICES NOT INDICATED TO CLOSE THE ARTERY USED FOR ACCESS. 16. ENSURE THE PATIENT¿S ARM IS RESTRAINED TO MINIMIZE MOVEMENT DURING DEVICE ACTIVATION; POTENTIAL HAZARDS OF PATIENT ARM MOVEMENT DURING ACTIVATION ARE HEMATOMA OR PSEUDOANEURYSM NEAR THE FISTULA SITE. 17. THE PUNCTURE SITE SHOULD BE CLOSED, AND HEMOSTASIS SHOULD BE ACHIEVED BY MANUAL COMPRESSION PER THE INSTRUCTIONS BELOW. USE OF CLOSURE DEVICES WITH THE WAVELINQ ENDOAVF SYSTEM MAY BE ASSOCIATED WITH AN INCREASED RISK OF ACCESS SITE COMPLICATIONS. 18. THE WAVELINQ ENDOAVF SYSTEM HAS ONLY BEEN EVALUATED FOR THE CREATION OF AN AVF BETWEEN THE ULNAR ARTERY AND CONCOMITANT ULNAR VEIN AND BETWEEN THE RADIAL ARTERY AND CONCOMITANT RADIAL VEIN IN THE CLINICAL STUDIES DESCRIBED BELOW. 19. REFER TO THE LATEST NATIONAL KIDNEY FOUNDATION KIDNEY DISEASE OUTCOMES QUALITY INITIATIVE (NKF KDOQI) GUIDELINES FOR RECOMMENDATIONS AND CONSIDERATIONS FOR AV ACCESS CREATION IN PATIENTS ON OR REQUIRING HEMODIALYSIS. FOR PATIENTS EXPECTED TO HAVE PROLONGED DURATIONS ON HEMODIALYSIS, A DISTAL TO PROXIMAL APPROACH TO AVF CREATION PROVIDES THE BEST OPPORTUNITY TO PRESERVE VESSELS FOR FUTURE VASCULAR ACCESS SITES FOLLOWING THE INDIVIDUAL PATIENT ESKD LIFEPLAN. 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. PRECAUTIONS 1. CARE SHOULD BE TAKEN TO AVOID THE PRESENCE OF FLUID ON THE ESU. 2. CARE SHOULD BE TAKEN DURING HANDLING OF THE ARTERIAL AND VENOUS CATHETERS IN PATIENTS WITH IMPLANTABLE CARDIAC DEFIBRILLATORS OR CARDIAC PACEMAKERS TO KEEP THE DISTAL 3 INCHES OF THE CATHETERS AT LEAST 2 INCHES FROM THE IMPLANTED DEFIBRILLATOR OR PACEMAKER. 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. 6. SOME PATIENTS WHO HAVE VEINS DEEPER THAN 6MM MAY REQUIRE SUPERFICIALIZATION. PREPLANNED VESSEL SUPERFICIALIZATION IS ACCEPTABLE AND NOT CONSIDERED AN ADDITIONAL INTERVENTION FOR FISTULA MATURATION, PER KDOQI CLINICAL PRACTICE GUIDELINE FOR VASCULAR ACCESS: 2018. 7. ENSURE THE PATIENT HAS ADEQUATE COLLATERAL BLOOD FLOW TO THE HAND BEFORE USE OF THE DEVICE. 8. PRIOR TO THE PROCEDURE, ENSURE THAT THE ACCESS LOCATION, ACCESS VESSELS, AND TARGET AVF LOCATION ARE OF APPROPRIATE SIZE TO ACCOUNT FOR THE DEVICES DURING USE. OVERSIZING THE DEVICE TO THE ACCESS VESSEL MAY INCREASE RISK OF VESSEL INJURY, WHICH MAY RESULT IN STENOSIS AND/OR OCCLUSION. VESSEL INJURY MAY IMPACT FUTURE DIALYSIS ACCESS OPTIONS AND/OR THE ABILITY TO PERFORM FUTURE ENDOVASCULAR PROCEDURES FROM THE TARGET ACCESS VESSELS. USERS SHOULD CONSIDER THE POTENTIAL RISK OF DISTAL ARTERIAL STENOSIS AND/OR OCCLUSION ON END STAGE RENAL DISEASE PATIENTS WHEN SELECTING VASCULAR ACCESS SITES FOR THE PROCEDURE. 9. ADJUNCTIVE PROCEDURES ARE EXPECTED TO BE REQUIRED AT THE TIME OF THE INDEX PROCEDURE TO INCREASE AND DIRECT BLOOD FLOW INTO THE AVF TARGET OUTFLOW VEIN TO ASSIST MATURATION. CARE SHOULD BE TAKEN TO PROACTIVELY PLAN FOR ANY ADJUNCTIVE PROCEDURES, SUCH AS EMBOLIZATION COIL PLACEMENT, WHEN USING THE DEVICE. 12. AVOID USING ALCOHOL, ANTISEPTIC SOLUTIONS, OR OTHER SOLVENTS TO PRE TREAT THE DEVICE BECAUSE THIS MAY CAUSE UNPREDICTABLE CHANGES IN THE COATING WHICH COULD AFFECT THE DEVICE SAFETY AND PERFORMANCE. POTENTIAL ADVERSE EVENTS THE KNOWN POTENTIAL RISKS RELATED TO THE WAVELINQ ENDOAVF SYSTEM AND PROCEDURE, A STANDARD AVF, AND ENDOVASCULAR PROCEDURES MAY INCLUDE, BUT ARE NOT LIMITED TO ABORTED OR LONGER PROCEDURE; ADDITIONAL PROCEDURES; BLEEDING, HEMATOMA OR HEMORRHAGE; BRUISING; BURNS. DEATH; ELECTROCUTION; EMBOLISM; FAILURE TO MATURE; FEVER; INCREASED RISK OF CONGESTIVE HEART FAILURE; INFECTION; NUMBNESS, TINGLING, AND/OR COOLNESS; OCCLUSION/STENOSIS; PROBLEM DUE TO SEDATION OR ANESTHESIA; PSEUDOANEURYSM; ANEURYSM; SEPSIS; STEAL SYNDROME OR ISCHEMIA. SWELLING, IRRITATION, OR PAIN; THROMBOSIS; TOXIC OR ALLERGIC REACTION; VENOUS HYPERTENSION (ARM SWELLING); VESSEL, NERVE, OR AVF DAMAGE OR RUPTURE; WOUND PROBLEM. STORAGE STORE THE WAVELINQ ENDOAVF SYSTEM IN A COOL, DARK, DRY PLACE. DO NOT EXPOSE TO ORGANIC SOLVENTS, IONIZING RADIATION, OR ULTRAVIOLET LIGHT. INSTRUCTIONS FOR USE ONCE THE WAVELINQ CATHETERS ARE REMOVED FROM THEIR PACKAGING, ENSURE ALL SUBSEQUENT PROCEDURES ARE PERFORMED IN A STERILE FIELD. INSPECTION PRIOR TO USE 1. BEFORE REMOVING THE WAVELINQ ENDOAVF SYSTEM FROM ITS PACKAGING, CAREFULLY INSPECT THE PACKAGING FOR ANY EVIDENCE OF DAMAGE. IF THERE IS EVIDENCE OF DAMAGE, DO NOT USE THE WAVELINQ ENDOAVF SYSTEM. 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. 7. TURN OFF ESU UNTIL READY FOR ENERGY DELIVERY IN ORDER TO PREVENT INADVERTENT ACTIVATION. WAVELINQ ENDOAVF SYSTEM PROCEDURE VASCULAR ACCESS 8. IDENTIFY THE VASCULAR ACCESS LOCATION DURING PREPROCEDURE PLANNING. THE ARTERIAL AND VENOUS ACCESS LOCATION MAY INCLUDE UPPER ARM ACCESS (BRACHIAL ARTERY/VEIN) OR VENOUS WRIST ACCESS (ULNAR VEIN OR RADIAL VEIN). 9. PREPARE THE VASCULAR ACCESS LOCATION WITH STERILE PREPARATION PER HOSPITAL PROTOCOL. 10. ADMINISTER ANESTHESIA OR CONSCIOUS SEDATION PER HOSPITAL PROTOCOL. 11. SECURE THE PATIENT¿S PROCEDURE ARM IN A RESTRAINT TO PREVENT ARM MOVEMENT. 12. USE TOURNIQUET OR BLOOD PRESSURE CUFF TO FACILITATE VESSEL ACCESS AS REQUIRED PER STANDARD PROTOCOL. 13. UNDER ULTRASOUND GUIDANCE, GAIN PERCUTANEOUS ACCESS TO TARGET VEIN WITH A PUNCTURE NEEDLE. DEVICES CAN BE INTRODUCED FROM AN UPPER ARM ACCESS (BRACHIAL VEIN) FOR THE PARALLEL CONFIGURATION OR FROM VENOUS WRIST ACCESS (ULNAR VEIN OR RADIAL VEIN) FOR THE ANTIPARALLEL CONFIGURATION. 14. INTRODUCE A GUIDEWIRE INTO THE VEIN THROUGH THE NEEDLE AND ADVANCE AN ADEQUATE LENGTH TO FACILITATE INTRODUCER SHEATH INSERTION. A MICROINTRODUCER SHEATH MAY BE USED TO FIRST CONFIRM INTRALUMINAL POSITION OF GUIDEWIRE. 15. INSERT A 5 FR SHEATH INTO THE VEIN OVER THE GUIDEWIRE. 16. INJECT CONTRAST MEDIA AND PERFORM A VENOGRAM TO ASSESS APPROPRIATENESS OF VESSEL ANATOMY FOR PROCEDURE. LIMIT THE DOSE OF CONTRAST DEPENDING ON THE PATIENT¿S RESIDUAL RENAL FUNCTION. ALTERNATE CONTRAST METHODS MAY BE USED AT THE DISCRETION OF PHYSICIAN. 17. UNDER ULTRASOUND GUIDANCE, GAIN ACCESS TO THE BRACHIAL ARTERY WITH A PUNCTURE NEEDLE AND INTRODUCE A GUIDEWIRE. 18. INSERT A 5 FR SHEATH INTO THE ARTERY OVER THE GUIDEWIRE. USING PHYSICIAN DISCRETION, ADMINISTER ANTICOAGULANT AND VASODILATOR INTRAVENOUSLY. 19. INSERT A 0.014 GUIDEWIRE INTO THE ARTERY AND DELIVER TO THE TARGET AVF CREATION SITE. 20. INSERT A 0.014 GUIDEWIRE INTO THE VEIN AND DELIVER TO THE TARGET AVF CREATION SITE. 21. ORIENT FLUOROSCOPE PERPENDICULAR TO THE TARGET ARTERY AND VEIN USING GUIDEWIRES, ULTRASOUND OR CONTRAST AS GUIDANCE. 22. REMOVE TOURNIQUET OR BLOOD PRESSURE CUFF (IF APPLIED). PREPARATION OF THE CATHETERS 23. CAREFULLY INSPECT THE WAVELINQ ENDOAVF SYSTEM POUCH FOR ANY EVIDENCE OF DAMAGE TO THE STERILE BARRIER. IF THERE IS EVIDENCE OF DAMAGE, DO NOT USE THE WAVELINQ ENDOAVF SYSTEM. 24. AFTER INSPECTION OF THE POUCH, CAREFULLY PEEL OPEN THE POUCH AND TRANSFER THE STERILE WAVELINQ ENDOAVF SYSTEM TO STERILE FIELD USING STANDARD TRANSFER PRECAUTIONS. AVF CREATION 25. REMOVE THE ARTERIAL CATHETER FROM THE PACKING CARD AND INSPECT FOR DAMAGE. EVALUATE THE DISTAL END OF THE CATHETER. IF IT IS SUSPECTED THAT THE STERILITY OR PERFORMANCE OF THE CATHETER HAS BEEN COMPROMISED, THE CATHETERS SHOULD NOT BE USED. 26. ADVANCE THE ARTERIAL CATHETER OVER THE 0.014 WIRE AND INSERT THROUGH THE ARTERIAL SHEATH, TAKING CARE NOT TO KINK THE DISTAL MAGNET ARRAYS. UNDER FLUOROSCOPIC GUIDANCE, ADVANCE THE CATHETER TO THE TARGET AVF LOCATION. 27. ROTATE THE ARTERIAL CATHETER UNTIL THE ILLUMINATION OF THE ROTATIONAL INDICATOR IS MAXIMIZED AND THE CONCAVE SURFACE OF THE BACKSTOP IS POINTED AT THE VENOUS WIRE. SEE FIGURE 1 FOR CATHETER CROSS SECTION. 28. REMOVE THE VENOUS CATHETER FROM THE PACKING CARD: A) REMOVING THE PLUG AND CABLE BUNDLE FROM THE CARD TABS B) UNCLIP THE VENOUS HANDLE AND THEN SLIDE THE CATHETER OUT OF ITS CONTAINMENT TUBE. REFER TO IMAGE OF WAVELINQ ENDOAVF SYSTEM CATHETERS AND PACKAGING IN DEVICE DESCRIPTION SECTION ABOVE. DO NOT REMOVE THE YELLOW HEMOSTASIS VALVE CROSSER. 29. INSPECT THE VENOUS CATHETER FOR DAMAGE. IF IT IS SUSPECTED THAT THE STERILITY OR PERFORMANCE OF THE CATHETER HAS BEEN COMPROMISED, THE CATHETER SHOULD NOT BE USED. 30. THE HYDROPHILIC COATING ON THE CATHETERS DOES NOT NEED TO BE HYDRATED OR WIPED PRIOR TO USE. 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. 32. UNDER FLUOROSCOPIC GUIDANCE, ADVANCE THE VENOUS CATHETER TOWARDS THE TARGET LOCATION UNTIL THE DISTAL MAGNETS OF THE VENOUS CATHETER BEGIN TO ENGAGE THE FIRST PROXIMAL MAGNETS OF THE ARTERIAL CATHETER. IN THIS LOCATION, PAUSE TO ROTATE THE VENOUS CATHETER UNTIL THEDANCING ILLUMINATION OF THE ROTATIONAL INDICATOR IS MAXIMIZED, AND THE ARC OF THE ELECTRODE IS POINTED AT THE ARTERIAL CATHETER. ADJUST THE ARTERIAL CATHETER AS NEEDED TO CONFIRM THAT CATHETERS ARE ALIGNED AND PREPARED FOR VENOUS CATHETER ADVANCEMENT. ADVANCE THE VENOUS CATHETER UNTIL THE ARC OF THE ELECTRODE IS CONGRUENT WITH CONCAVE SURFACE OF THE ARTERIAL BACKSTOP. ELECTRODE SHOULD APPEAR COMPRESSED. CONFIRM THAT THE DISTAL ROTATIONAL INDICATORS APPEAR ALIGNED AND ROTATIONALLY SIMILAR. 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 PREASSEMBLED 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. 40. HOLD PATIENT¿S PROCEDURE ARM WITH FIRM PRESSURE TO MINIMIZE ARM FLEXION AND ROTATION DURING ENERGY DELIVERY. 41. TURN ON ESU AND AGAIN 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. 42. WHILE IMAGING WITH FLUOROSCOPY, DELIVER RF ENERGY BY FIRMLY PRESSING AND HOLDING THE YELLOW CUT SWITCH ON THE ELECTROSURGICAL PENCIL UNTIL THE AUDIBLE ESU ACTIVATION TONE STOPS. THE ELECTRODE SHOULD VISIBLY ADVANCE AND TOUCH THE ARTERIAL BACKSTOP. IF ELECTRODE DOES NOT CONTACT BACKSTOP, AN ADDITIONAL ACTIVATION MAY BE ADMINISTERED UNDER THE CONDITION THAT THE CATHETERS HAVE NOT BEEN MOVED FROM THEIR ORIGINAL POSITION. DO NOT ACTIVATE THE DEVICE MORE THAN 3 TIMES. 43. REMOVE THE VENOUS CATHETER. REMOVE THE ARTERIAL CATHETER. 44. PERFORM ARTERIOGRAM VIA THE ARTERIAL SHEATH TO CONFIRM AVF CREATION. ALTERNATE CONTRAST METHODS MAY BE USED AT THE DISCRETION OF PHYSICIAN 45. EMBOLIZATION OF A BRACHIAL VEIN IS RECOMMENDED AT THIS STAGE OF THE PROCEDURE TO REDIRECT BLOOD FLOW TO THE SUPERFICIAL VEINS AND SUPPORT MATURATION OF THE DESIRED TARGET CANNULATION AREA. EMBOLIZATION IS RECOMMENDED DURING THE INDEX PROCEDURE FOR PATIENTS WHO HAVE MORE THAN ONE BRACHIAL VEIN, WHERE A BRACHIAL VEIN IS OBSERVED TO HAVE SIGNIFICANT OUTFLOW FROM THE AVF. EMBOLIZATION MAY NOT BE NEEDED IN CASES WHERE THE BRACHIAL VEIN OUTFLOW FROM THE AVF IS MINIMAL. FOLLOW MANUFACTURER USE AND SIZING RECOMMENDATIONS PER EMBOLIZATION DEVICE INSTRUCTIONS FOR USE. BRACHIAL VEIN EMBOLIZATION COULD OCCUR IN PREVIOUS STEPS DEPENDING ON PATIENT ANATOMY AND PHYSICIAN DISCRETION. 46. REMOVE THE ARTERIAL SHEATH AND VENOUS SHEATH AND ACHIEVE PUNCTURE SITE HEMOSTASIS USING MANUAL COMPRESSION. THE ARTERIAL ACCESSSITE SHOULD PROVIDE A BONY BACKSTOP (THE HUMERUS BONE) TO AID IN COMPRESSION. THE OPERATOR SHOULD HOLD MANUAL COMPRESSION USING PRESSURE FROM THE HAND/FINGERS DIRECTLY OVER THE PUNCTURE SITE AND MAINTAIN PRESSURE FOR AT LEAST 20 MINUTES. HEMOSTASIS AT ACCESSSITES SHOULD BE VERIFIED WITH ULTRASOUND. B5, D4 (UNIQUE IDENTIFIER (UDI) #), G3, H6 (PATIENT, METHOD) SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL 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.
IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT DURING SCREENING OF A PATIENT FOR ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION, A NEW STENOSIS WAS IDENTIFIED AT THE DISTAL LOCATION OF THE RADIAL ARTERY. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT DURING SCREENING OF A PATIENT FOR ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION, A NEW STENOSIS WAS IDENTIFIED AT THE DISTAL LOCATION OF THE RADIAL ARTERY. IT WAS FURTHER REPORTED AT A TWO WEEK FOLLOW UP VISIT BY PHYSICAL ASSESSMENT THAT THE STUDY ENDOAVF WAS NOT MATURED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 382591 | WAVELINQ 4FR P | ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE | PQK | CLEARSTREAM TECHNOLOGIES LTD. | CMJX0296 | 00801741189104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Female | Required Intervention |