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

Model Number	ENSITE-FF-01
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
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 a pulmonary vein isolation procedure, during set up with the patient on the table, it was noted that pins on the field frame cable were bent resulting in cancellation of the procedure.After the magnetic sensors were put in place and it was attempted to connect the field frame generator the issue was found.Attempts to recorrect the pins were unsuccessful, and the procedure was cancelled.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6, h11.The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported bent cable pins and subsequent cancellation 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.
Additional Manufacturer Narrative
Additional information: b5, d4, g1, g3, h2, h3, h4, h6, h11.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be determined.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.
Event or Problem Description
During a pulmonary vein isolation procedure, during set up with the patient on the table, it was noted that pins on the field frame port were bent resulting in cancellation of the procedure.After the magnetic sensors were put in place and it was attempted to connect the field frame generator the issue was found.Attempts to recorrect the pins were unsuccessful, and the procedure was cancelled.

• Brand Name: ENSITE¿ X FIELD FRAME 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: 20703130
• Report Number: 2184149-2024-00184
• Device Sequence Number: 18195510
• Product Code: DQK
• UDI-Device Identifier: 05415067032195
• UDI-Public: (01)05415067032195(21)19204833(10)8143346
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 04/04/2025

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-FF-01
• Device Catalogue Number: ENSITE-FF-01
• Device Lot Number: 8143346
• 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: 10/25/2024
• Supplement Date Received by Manufacturer: 01/22/2025; 03/06/2025
• Initial Report FDA Received Date: 11/17/2024
• Supplement Report FDA Received Date: 01/22/2025; 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2021
• 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