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	12/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after three attempts to create an ulnar-ulnar fistula, the venous catheter allegedly failed to create the fistula and there was arm flexion during activation.Therefore, the catheters were removed from the patient without incident.It was further reported that another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 08/2021).
Additional Manufacturer Narrative
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 result of the investigation is inconclusive for the reported failure to cut issue.A functional examination could not be carried out due to the condition of the returned device.The electrode was returned broken within its housing.There was blood observed around the electrode.Based upon the available information a definitive root cause could not be determined.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.D4 (expiry date: 08/2021).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.
Event or Problem Description
It was reported that after three attempts to create an ulnar-ulnar fistula, the venous catheter allegedly failed to create the fistula and there was arm flexion during activation.Therefore, the catheters were removed from the patient without incident.It was further reported that another device was used to complete the procedure.There was no reported patient injury.

• 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: 11221823
• Report Number: 9616666-2021-00002
• Device Sequence Number: 4238963
• Product Code: PQK
• UDI-Device Identifier: 00801741182754
• UDI-Public: (01)00801741182754
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/24/2021

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: S0080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 03/10/2021
• 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