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

Model Number	W04200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.(expiry date: 08/2021).
Event or Problem Description
It was reported through results of a clinical trial, post device implantation perf/lateral radial vein stenosis was reported.The current patient status was not provided.
Event or Problem Description
It was reported through results of a clinical trial, post device implantation perf/lateral radial vein stenosis was reported.The current patient status was not provided.
Additional Manufacturer Narrative
H10: manufacturing review: 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 to the manufacturer for evaluation.The result of the investigation is confirmed for the reported stenosis issue.However there was no reported device malfunction.It was outlined within the communications that the relationship to the device is not related and the relationship to the procedure is not related.The relationship to av access circuit is possibly related.The definitive root cause for the reported stenosis issue 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: potential adverse events the known potential risks related to the wavelinq¿ 4f endoavf system and procedure, a standard avf, and endovascular proceduresm ay 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.H10: (expiry date: 08/2021).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 4 FR
• 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: 11918545
• Report Number: 9616666-2021-00087
• Device Sequence Number: 14247859
• Product Code: PQK
• UDI-Device Identifier: 00801741182754
• UDI-Public: (01)00801741182754
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K182796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

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: S0079
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 08/23/2021
• 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: Required Intervention
• Patient Age: 34 YR