MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. WAVELINQ 4FR; ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE

Model Number	W04200
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(expiry date: 03/2021).
Event or Problem Description
It was reported that during creation of left arm ulnar fistula, the catheter allegedly failed to cut tissue, therefore converted to a surgical fistula.There was no reported patient injury.
Event or Problem Description
It was reported that during creation of left arm ulnar fistula, the catheter allegedly failed to cut tissue, therefore converted to a surgical fistula.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: the sample was returned for evaluation.The sample evaluation observed that the electrode was slightly deformed and slightly flattened within its housing.The device activated successfully, however failed to cut through the tissue likely due to the electrode reduced profile height.The result of the investigation is confirmed for the reported failure to cut issue.The definitive root cause could not be determined based upon the available information.Labeling review: the instructions 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: 03/2021).H11: h6 (method, result, conclusion).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.

• Brand Name: WAVELINQ 4FR
• Common Device Name: ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 11299801
• Report Number: 9616666-2021-00012
• Device Sequence Number: 610910
• Product Code: PQK
• UDI-Device Identifier: 00801741182754
• UDI-Public: (01)00801741182754
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K182796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: W04200
• Device Catalogue Number: W04200
• Device Lot Number: S0056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR