MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE¿ X PATIENT REFERENCE SENSOR; WIRE, GUIDE, CATHETER

Model Number	ENSITE-PRSFRNT-01
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a congenital atrioventricular reentrant tachycardia procedure, there was a delay due to a communication issue with the prs cables.The prs was initially visible but did not stay visible.The system was rebooted, and the prs-a cable and field frame were both moved and exchanged, but the issue persisted.The prs-p cable could not be moved due to ga.The case was reverted to navx to successfully perform the procedure without adverse consequences.The prs sensors were tested after the procedure, and exchanging the prs-p cable made the sensors visible with some flickering.Exchanging the prs-a cable made sensors visible.Both cables seemed to cause an issue as the prs-p caused a sensor issue, and the prs-a would intermittently do the same.
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.
Additional Manufacturer Narrative
One ensite x patient reference sensor was received for evaluation at tech center.The prs was evaluated by performing a continuity test, which revealed all coils were functional.Evaluation testing was successful as the prs was functioning as intended.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the information and investigation provided to abbott, the cause of the reported communication issue and subsequent delay was not due to this device.

• Brand Name: ENSITE¿ X PATIENT REFERENCE SENSOR
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 21542485
• Report Number: 2184149-2025-00041
• Device Sequence Number: 20927337
• Product Code: DQX
• UDI-Device Identifier: 05415067033284
• UDI-Public: 05415067033284
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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-PRSFRNT-01
• Device Catalogue Number: ENSITE-PRSFRNT-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 05/20/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENSITE¿ X PATIENT REFERENCE SENSOR
• Patient Sex: Unknown