MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE¿ X FIELD FRAME CABLE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-FF-4.5C-01
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Model/lot number information was not able to be obtained for this device.Therefore, full udi information(d4) and 510k(g3) are not available.
Event or Problem Description
During an atrial fibrillation procedure, there was a communication issue with the amplifier and a bent pin on the field frame cable resulting in cancellation of the procedure.The field frame generator was not able to connect to the amplifier.Despite multiple restarts of the amplifier and display workstation, and after verifying all connections, it was found that one of the pins on the field frame cable was broken.The cable and field frame were exchanged but the issue did not resolve.The system was switched to navx mode, however the catheters were not visible.It is alleged that the amplifier was causing the issue.Due to the issue not being resolved, the procedure was cancelled.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6.The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported bent pin issue and subsequent cancellation could not be determined.

• Brand Name: ENSITE¿ X FIELD FRAME CABLE
• 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: 23376241
• Report Number: 2184149-2025-00168
• Device Sequence Number: 8965236
• Product Code: DQK
• UDI-Device Identifier: 05415067032232
• UDI-Public: 05415067032232
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 01/19/2026

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: ENSITE-FF-4.5C-01
• Device Catalogue Number: ENSITE-FF-4.5C-01
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENSITE¿ X AMPLIFIER
• Patient Sex: Unknown