MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. WAVELINQ RF GENERATOR; ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE

Model Number	ESU-1
Medical Device Problem Codes	Failure to Deliver Energy (1211); Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the serial number for the device was provided, a review of the device history records is currently being performed.The device 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.
Event or Problem Description
It was reported that during an arteriovenous fistula (avf) procedure, the device allegedly failed to cut the tissue.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Therefore a device history record review is not required.Investigation summary: the device was returned for evaluation.The wavelinq rf generator was visually inspected upon receipt and was found to be normal.The device was functionally tested and found that auto bipolar out of specifications and the unit activates at the correct voltage level but turns off 100 ohms to soon.This investigation has been determined to be unconfirmed for the reported device allegedly failed to deliver energy during an arteriovenous fistula (avf) procedure.The root cause cannot be determined as problem cannot be reproduced.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: the fda rn number for the supplemental mdr was updated as 9616666 since clearstream is the legal manufacturer for wavelinq products and the appropriate manufacturing site (g1) and manufacturer (d3) fields were updated accordingly.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.
Event or Problem Description
It was reported that during an arteriovenous fistula (avf) procedure, the device allegedly failed to deliver energy.There was no reported patient injury.

• Brand Name: WAVELINQ RF GENERATOR
• Common Device Name: ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; suite 250; enniscorthy, co. wexford TX N A ; EI N A
• MDR Report Key: 10470624
• Report Number: 3011392541-2020-00009
• Device Sequence Number: 14271348
• Product Code: GEI
• UDI-Device Identifier: 00868260000228
• UDI-Public: (01)00868260000228
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2021

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: ESU-1
• Device Catalogue Number: ESU-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1