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

Model Number	W04200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stenosis (2263); Obstruction/Occlusion (2422)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported in an article in division of vascular surgery titled 'percutaneous arteriovenous fistula creation with the 4f wavelinq endoavf system, after post procedure there were forty three occurrences of occlusion or stenosis.The re-intervention was performed.However, the current status of the patients is unknown.
Additional Manufacturer Narrative
Todd berland, jason clement, nicholas inston, paul kreienberg and kenneth ouriel (2021).Percutaneous arteriovenous fistula creation with the 4f wavelinq endoavf system.Journal of vascular surgery, 75(3):1038-1046.E3.Doi: 10.1016/j.Jvs.2021.09.025 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.Device not returned.
Event or Problem Description
It was reported in an article in division of vascular surgery titled 'percutaneous arteriovenous fistula creation with the 4f wavelinq endoavf system', after post procedure there were forty three occurrences of occlusion or stenosis.The re-intervention was performed.However, the current status of the patients is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical sample was not returned for evaluation.No specific device failure modes were alleged.The result of the investigation is confirmed for the patient reports of adverse effects of stenosis post arteriovenous fistula creations.The definitive root cause for the reported patients adverse effects of stenosis after arteriovenous fistula creations 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: 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.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.Precautions: 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.Warnings: 3.The wavelinq 4f 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 4f endoavf system should not be used in patients who have a known allergy or reaction to any drugs/ fluids used in this procedure.5.The wavelinq 4f endoavf system should not be used in patients who have known adverse reactions to moderate sedation and/or anesthesia.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.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 4f 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.Potential adverse events: the known potential risks related to the wavelinq 4f 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; 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.Todd berland, jason clement, nicholas inston, paul kreienberg and kenneth ouriel (2021).Percutaneous arteriovenous fistula creation with the 4f wavelinq endoavf system.Journal of vascular surgery, 75(3):1038-1046.E3.Doi: 10.1016/j.Jvs.2021.09.025.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.

• 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
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14573013
• Report Number: 9616666-2022-00122
• Device Sequence Number: 12290573
• Product Code: PQK
• UDI-Device Identifier: 00801741182754
• UDI-Public: (01)00801741182754
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K182796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: W04200
• Device Catalogue Number: W04200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown