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

Model Number	ENSITE-ACBL-160-01
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a supraventricular tachycardia procedure.There was a procedural delay.The potentials of electrodes 1-2 did not appear after insertion into the patient and they would not display as expected either.Electrodes 3-4 were normal.The cable and catheter were replaced with no resolution.The procedure was switched to non-abbott manufacturer (johnson & johnson) to complete the procedure.Later on, it was determined that the ensite x ampere connect cable was the cause of the issue resolved after replacement.There were no patient consequences.
Additional Manufacturer Narrative
The product's lot number could not be obtained, therefore the primary di number is provided (d4), but full udi information is not available.The results of the investigation are inconclusive since the device was not returned for analysis.Review of the batch record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident of a signal potential issue could not be determined.

• 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24745349
• Report Number: 2184149-2026-00087
• Device Sequence Number: 8707953
• Product Code: DQK
• UDI-Device Identifier: 05415067033376
• UDI-Public: 05415067033376
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K202066
• 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): 03/31/2026

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-ACBL-160-01
• Device Catalogue Number: ENSITE-ACBL-160-01
• 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: 03/04/2026
• Initial Report FDA Received Date: 03/31/2026
• 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
• Patient Sex: Unknown