MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE¿ VELOCITY¿ CARDIAC MAPPING SYSTEM; Computer, diagnostic, programmable

Model Number	600073552
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One ensite velocity¿ amplifier was received for evaluation.Visual inspection of the front panel ports identified a bent pin within the navx connector assembly, reproducing the reported symptom.Based on the information provided to abbott and the investigation performed, the reported event was able to be confirmed, and the root cause was attributed to physical damage to the navx connector assembly.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
During the procedure, the procedure was canceled due to communication issues.With the patient prepared, there was an error message saying "left leg patch not recognized" and the patches would not validate.When the error message appeared, it did not transmit catheter movement.The patches were replaced, and a new navlink patch box was used, but the issue was not resolved.It is alleged that the communication issue was due to the ensite velocity amplifier.The procedure was unable to be completed.

• Brand Name: ENSITE¿ VELOCITY¿ CARDIAC MAPPING SYSTEM
• 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: 24628404
• Report Number: 2184149-2026-00054
• Device Sequence Number: 8689268
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: (01)05414734210713(10)7332845
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K141050
• 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): 03/18/2026

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: 600073552
• Device Catalogue Number: 600073552
• Device Lot Number: 7332845
• Was Device Available for Evaluation?: Yes
• 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: 02/19/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2020
• 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