WAVELINQ ENDOAVF SYSTEM
Report
- Report Number
- 9616666-2021-00091
- Event Type
- Malfunction
- Date Received
- June 8, 2021
- Date of Event
- May 18, 2021
- Report Date
- August 25, 2021
- Manufacturer
- CLEARSTREAM TECHNOLOGIES LTD.
- Product Code
- PQK
- UDI-DI
- 00801741189104
- PMA / PMN Number
- K192239
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
H10: MANUFACTURING REVIEW: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. INVESTIGATION SUMMARY: THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE RESULT OF THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE TO ALIGN ISSUE. THE ROOT CAUSE FOR THE REPORTED FAILURE TO ALIGN ISSUE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION RECEIVED FROM THE FIELD COMMUNICATIONS. 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. PRECAUTIONS 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. 5. KEEP MAGNETIC ENDS OF CATHETERS AWAY FROM OTHER METALLIC OBJECTS WHICH MAY BECOME ATTRACTED AND COLLIDE WITH DEVICES. 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 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. 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 : DEVICE NOT RETURNED.
H10: MANUFACTURING REVIEW: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. INVESTIGATION SUMMARY: THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE RESULT OF THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE TO ALIGN ISSUE. THE ROOT CAUSE FOR THE REPORTED FAILURE TO ALIGN ISSUE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION RECEIVED FROM THE FIELD COMMUNICATIONS. 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. PRECAUTIONS 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. 5. KEEP MAGNETIC ENDS OF CATHETERS AWAY FROM OTHER METALLIC OBJECTS WHICH MAY BECOME ATTRACTED AND COLLIDE WITH DEVICES. 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 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. THE DEVICE WAS NOT RETURNED.
IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO ALIGN. THERE WAS NO PATIENT CONTACT.
IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO ALIGN. THERE WAS NO REPORTED PATIENT INJURY.
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.
IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE DEVICE ALLEGEDLY HAD ACTIVATION PROBLEM. THERE WAS NO PATIENT CONTACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 859102 | WAVELINQ ENDOAVF SYSTEM | ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE | PQK | CLEARSTREAM TECHNOLOGIES LTD. | WQ4300 | UNKNOWN | 00801741189104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |