MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	600079116
Medical Device Problem Code	Electromagnetic Interference (1194)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a rf atrial fibrillation procedure, when using the ensite velocity amplifier, distortion of the ablation catheter was observed resulting in cancellation of the procedure.Transseptal puncture and mapping of the left atrium had been completed.Troubleshooting included replacing the ampere generator, genconnect cable, and grounding patch, but the issue persisted.It was noted that the grounding patch was above the system reference, and the ampere generator was plugged into the same circuit for power.The procedure was cancelled with no adverse consequences to the patient.
Additional Manufacturer Narrative
One ensite velocity¿ amplifier was received for evaluation.Visual inspection revealed the front panel ports, chassis, and labels were show signs of wear consistent with use over time.Power was applied to the amplifier and the amplifier passed power-on-self-test (post).The amplifier went status ready ¿green¿ and communicated with the test ensite computer.Evaluation of the board status showed all boards status are green indicating passing results.Evaluation of the logs revealed discovered notable symptoms.There was a single incidence of a communication symptom (con/son) (b(6) 2024, with slot 6 (catheter amplifier board).There was multiple logs with multiple qbs¿s assigned to the current source board.It was noted that there was also timing issues related to the slot 2 previously.As the current source board is the primary source for ground and impedance mapping, which had communication timing issues, it could not be eliminated from the distortion of the reported symptom, and so was retained and confirmed as a cause.The reported event was retained as a confirmation by inspection of the logs.Based on the information provided to abbott and the investigation performed, the reported event was not able to be reproduced, however the root cause was retained as a communication timing symptom of the current source board.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.

• Brand Name: ENSITE VELOCITY¿ SYSTEM VELOCITY 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24465374
• Report Number: 2184149-2026-00050
• Device Sequence Number: 9360857
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: (01)05414734210713(10)10052678
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K201181
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: 600079116
• Device Catalogue Number: 600079116
• Device Lot Number: 10052678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown