MAUDE Adverse Event Report: ABBOTT MEDICAL CURRENT¿ PFA GENERATOR; No Match

Model Number	PFA-GEN-01
Medical Device Problem Codes	Device Emits Odor (1425); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One pulse field ablation (pfa) generator (sn: (b)(6) was received for evaluation.The field reported event was able to be confirmed by visual inspection.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 attributed to electrical thermal damage to the bfc pinnacle hv 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.
Event or Problem Description
This report is to advise of thermal damage that was noted during analysis.During the pfa procedure without disconnecting or moving anything, the current pfa generator, suddenly made a loud sound and turned off.When this happened, upon turning it back on, the screen to access the case was grayed out and inaccessible.The generator was restarted several times, connecting and disconnecting everything, but the issue was not resolved.The procedure was continued using cryoablation from a non-abbott system without any further issues.

• Brand Name: CURRENT¿ PFA GENERATOR
• Common Device Name: No Match
• 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: 25028840
• Report Number: 2184149-2026-00122
• Device Sequence Number: 18675395
• Product Code: QZI
• UDI-Device Identifier: 05415067051516
• UDI-Public: (01)05415067051516(10)11137716
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P250022
• 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
• Report Date (Section B): 04/28/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: PFA-GEN-01
• Device Catalogue Number: PFA-GEN-01
• Device Lot Number: 11137716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• 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: 04/23/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2025
• 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