WAVELINQ 4F CATHETER
Report
- Report Number
- 9616666-2021-00093
- Event Type
- Malfunction
- Date Received
- June 15, 2021
- Date of Event
- May 21, 2021
- Report Date
- September 20, 2021
- Manufacturer
- CLEARSTREAM TECHNOLOGIES LTD.
- Product Code
- PQK
- PMA / PMN Number
- K182796
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- Reporter Occupation
- PHYSICIAN
Narratives
H10: MANUFACTURING REVIEW: A COMPLAINT HISTORY REVIEW WAS PERFORMED. THIS IS THE FIRST COMPLAINT REPORTED FOR THIS PRODUCT/LOT NUMBER COMBINATION. HOWEVER, DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE RESULT OF THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE TO CUT ISSUE. THE DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE TO CUT ISSUE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION RECEIVED FROM THE FIELD COMMUNICATIONS. LABELING REVIEW: THE INSTRUCTION FOR USE FOR THE WAVELINQ ENDOAVF SYSTEM WAS REVIEWED AND CONTAINS THE FOLLOWING INFORMATION RELEVANT TO THE REPORTED EVENT: 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. AVF CREATION: 25. REMOVE THE ARTERIAL CATHETER FROM THE PACKING CARD AND INSPECT FOR DAMAGE (SEE FIGURES 1-3). 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. 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¿ 4F ENDOAVF SYSTEM CATHETERS AND PACKAGING IN ¿SYSTEM 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 THOUGH 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 THE 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 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. 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. H10: D4 (EXPIRY DATE: 06/2022). H11: 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. H3 OTHER TEXT : DEVICE NOT RETURNED.
H10: MANUFACTURING REVIEW: A COMPLAINT HISTORY REVIEW WAS PERFORMED. THIS IS THE FIRST COMPLAINT REPORTED FOR THIS PRODUCT/LOT NUMBER COMBINATION. HOWEVER, A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE RESULT OF THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE TO CUT ISSUE. THE DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE TO CUT ISSUE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION RECEIVED FROM THE FIELD COMMUNICATIONS. LABELING REVIEW: THE INSTRUCTION FOR USE FOR THE WAVELINQ ENDOAVF SYSTEM WAS REVIEWED AND CONTAINS THE FOLLOWING INFORMATION RELEVANT TO THE REPORTED EVENT: 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. AVF CREATION: 25. REMOVE THE ARTERIAL CATHETER FROM THE PACKING CARD AND INSPECT FOR DAMAGE (SEE FIGURES 1-3). 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. 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¿ 4F ENDOAVF SYSTEM CATHETERS AND PACKAGING IN ¿SYSTEM 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 THOUGH 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 THE 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 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. 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. H10: D4 (EXPIRY DATE: 06/2022) H11: 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 THAT DURING AN ARTERIOVENOUS FISTULA (AVF) CREATION, THE DEVICE ALLEGEDLY FAILED TO CREATE FISTULA. THERE WAS NO REPORTED PATIENT INJURY.
IT WAS REPORTED THAT DURING AN ARTERIOVENOUS FISTULA (AVF) CREATION, THE DEVICE ALLEGEDLY FAILED TO CREATE FISTULA. THERE WAS NO REPORTED PATIENT INJURY.
AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. THE CATALOG NUMBER IDENTIFIED HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE WAVELINQ 4F ENDOAVF SYSTEM PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE WAVELINQ 4F ENDOAVF SYSTEM PRODUCTS ARE IDENTIFIED. (EXPIRY DATE: 06/2022). DEVICE PENDING RETURN.
IT WAS REPORTED THAT DURING AN ARTERIOVENOUS FISTULA (AVF) CREATION, THE DEVICE ALLEGEDLY FAILED TO CREATE FISTULA. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 897975 | WAVELINQ 4F CATHETER | ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE | PQK | CLEARSTREAM TECHNOLOGIES LTD. | CMEU0421 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other |