MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE¿ X AMPERE CONNECT CABLE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-ACBL-60-01
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
During an atrial fibrillation procedure, the ampere connect cable had a connection issue which resulted in a delay to the procedure.The tactiflex catheter was plugged in, but it was noted that it could not be selected as a roving catheter on the mapping system.The catheter setup screen showed the catheter plugged in, but it was unable to connect to the ampere connect port.It was attempted to reconnect the catheter, and then restart the tactisys, ampere, ensite x amplifier, and ensite x dws.All pieces of equipment were registering as connected on the ensite x dws.It was verified that the correct tactisys cable was being used to connect the tactisys to the ampere.A different tactiflex yellow/green cable from the tactisys to ampere was also attempted to be used.Then the tactisys and ampere were exchanged for spare systems at this account.At this point, it was attempted to replace the catheter, but the replacement catheter did not resolve the issue.It was noted that the replacement catheter was from the same lot as the first, so it was attempted to open another catheter from a different lot number.However, this also did not resolve the issue.It was then attempted to replace the ensite x amplifier from a spare system.In the process of unplugging the ensite x amplifier that was currently in use, it was noted that the ampere connect cable felt loose when attempting to unplug it.The cable was completely unplugged and replugged, and the issue was resolved.The procedure proceeded with no adverse consequences to the patient.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the connection issue could not be determined.The product's lot number could not be obtained, therefore the primary di number is provided (d4), but full udi information is not available.

• Brand Name: ENSITE¿ X AMPERE CONNECT CABLE
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE 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: 19983617
• Report Number: 2184149-2024-00136
• Device Sequence Number: 2725225
• Product Code: DQK
• UDI-Device Identifier: 05415067033383
• UDI-Public: 05415067033383
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K231415
• 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,Followup
• Report Date (Section B): 09/10/2024

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?: 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: 08/05/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/10/2024
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 102 KG