MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE¿ X AMPERE CONNECT CABLE; Computer, diagnostic, programmable

Model Number	ENSITE-ACBL-60-01
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One ensite x to ampere 60¿ cable (acbl) was received for evaluation.The reported event was able to be duplicated by resistance testing.It was observed that channels 36 (no line) and 44 (ablation 2) were electrically open.This would cause non-functionality to the ablation 2 line from the ampere to the amplifier.Based on the investigation and information provided to abbott, the reported event was able to be confirmed, and the root cause was attributed to electrical opens within the ampere connect cable.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 the svt procedure, signal issues resulted in a delay in procedure.Upon insertion of the tactiflex ablation catheter, it was noted that electrode 2 appeared distorted.The catheter in se port 1 was unplugged and re-plugged after deleting the catheter from the catheter list.The amplifier was rebooted.The tactisys and the green to yellow ablation cable for the tactiflex were both replaced and the ampere was rebooted.All cables from the tactisys were disconnected and reconnected.The issue was not resolved so the catheter was replaced with no resolution.The ampere connect cable was replaced to resolve the issue and the procedure was completed with no adverse consequences to the patient.

• Brand Name: ENSITE¿ X AMPERE CONNECT 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23366320
• Report Number: 2184149-2025-00166
• Device Sequence Number: 15974890
• Product Code: DQK
• UDI-Device Identifier: 05415067033383
• UDI-Public: 05415067033383
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K242016
• 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
• Report Date (Section B): 10/23/2025

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-ACBL-60-01
• Device Catalogue Number: ENSITE-ACBL-60-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2025
• 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: 09/26/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female
• Patient Weight: 72 KG