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

Model Number	W04200
Medical Device Problem Codes	Device-Device Incompatibility (2919); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer and the evaluation is still pending.The investigation of the reported event is currently underway.Expiry date (07/2021).
Event or Problem Description
It was reported that during an arteriovenous fistula procedure through the brachial vein, the device allegedly got stuck while entering the sheath and increased pressure was applied to advance the device further.It was also reported that electrode was unusable.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during an arteriovenous fistula procedure through the brachial vein, the device allegedly got stuck while entering the sheath and increased pressure was applied to advance the device further.It was also reported that electrode was unusable.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
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.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: a sample evaluation was performed.Bends to the catheter were noted just proximal to the proximal magnets.The electrode height was measured and found to be approximately 1.16mm.The venous catheter was successfully passed through a 4f in-house terumo sheath.The investigation is confirmed for material deformation based on the sample evaluation.The investigation is inconclusive for device-device incompatibility and difficult to advance since the arterial catheter was not returned for evaluation.The root cause could not be determined based upon available information.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: (expiry date: 07/2021).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.

• Brand Name: WAVELINQ 4 FR
• Common Device Name: ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford AZ N A ; EI N A
• MDR Report Key: 10565817
• Report Number: 2020394-2020-05737
• Device Sequence Number: 2705704
• Product Code: PQK
• UDI-Device Identifier: 00801741182754
• UDI-Public: (01)00801741182754
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2021

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: S0073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 02/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1