MAUDE Adverse Event Report: ABBOTT MEDICAL TACTISYS¿ IBI RADIOFREQUENCY CABLE; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	PN-004 515
Medical Device Problem Codes	Failure to Power Up (1476); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi information (d4) and 510k (g3) are not provided within this report as this product (model h700489) is an ous configuration not available in the us and is therefore not referenced in the gudid database.
Event or Problem Description
During a procedure, there was an ampere generator boot up issue and an error displayed stating "generator malfunction".Restarting the ampere generator did not resolve the issue.The procedure was then cancelled.
Additional Manufacturer Narrative
Additional information: b5, d1, d4, e1, g3, h2.The product's lot number could not be obtained; therefore the primary di number is provided (d4), but full udi information is not available.
Event or Problem Description
During a procedure, there was an ampere generator boot up issue and an error displayed stating "generator malfunction".Restarting the ampere generator did not resolve the issue.The procedure was then cancelled.It was later determined the issue was due to the connection cable between the ampere rf generator and the tactisys quartz module.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One tactisys radio frequency (rf) cable was received for evaluation.Visual inspection revealed that the connector ports were free of physical damage, and a section along the cable sheath showed internal wiring bunching.The cable was tested by resistance pin-to-pin and revealed the cable was electrically shorted.Any electrical short will cause unexpected results, including non-functionality.During investigations we confirmed that this shorted rf cable causes the ampere post to display ampere malfunction results.If the ampere was passed the timing of the post the rf cable only caused no catheter detection.The reported event was able to be duplicated by visual and functional inspection and resistance testing.Based on the investigation and information provided to abbott this symptom was able to be confirmed, and the root cause was attributed to an electrical open of the internal wires of the rf cable.The product's lot number could not be obtained, therefore the primary di number was provided (d4), but full udi information is not available.

• Brand Name: TACTISYS¿ IBI RADIOFREQUENCY CABLE
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: 23187806
• Report Number: 2184149-2025-00162
• Device Sequence Number: 18640060
• Product Code: OAE
• UDI-Device Identifier: 07640157990064
• UDI-Public: 07640157990064
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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,Followup
• Report Date (Section B): 01/20/2026

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: PN-004 515
• Device Catalogue Number: PN-004 515
• Device Lot Number: 6874462
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: 10/14/2025; 01/15/2026
• Initial Report FDA Received Date: 10/01/2025
• Supplement Report FDA Received Date: 11/09/2025; 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2019
• 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