MAUDE Adverse Event Report: ABBOTT MEDICAL WORKMATE¿ CLARIS¿ AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H700150
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the pulsed field ablation procedure for atrial fibrillation with workmate claris and a non-abbott (farawave) catheter, the claris was started up as usual, and when applying pulse with the farawave catheter, ¿no signal¿ was displayed on the screen and the waveform was not displayed for about 30 seconds to 1 minute, which occurred about 4 times throughout the procedure.Waiting for the waveform to be displayed or power cycling the amplifier and dws four times each resolved the issue, but it occurred frequently.In addition, the catheter pins were not connected directly to claris cim, but via the non-abbott (carto piu) system.The procedure was completed without replacing the claris and there were no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the information received by abbott, the cause of the reported signal issue and subsequent delay remains unknown.

• Brand Name: WORKMATE¿ CLARIS¿ AMPLIFIER
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22480025
• Report Number: 2184149-2025-00128
• Device Sequence Number: 8668976
• Product Code: DQK
• UDI-Device Identifier: 05415067001504
• UDI-Public: (01)05415067001504(10)5050757
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2025

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: H700150
• Device Catalogue Number: H700150
• Device Lot Number: 5050757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2015
• 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
• Patient Sex: Unknown