MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE X EP SYSTEM PATIENT REFERENCE SENSOR 3; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-PRSBACK-01
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	10/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturing ref: 2184149-2022-00254.During the atrial fibrillation procedure, a pericardial perforation occurred after an issue with the prs-p sensors changing positions due to patient coughing and body movement while mapping in the left atrium.Due to the change in position of the sensors the system could not collect any information such as geometry.The sensors on the patient's back were then fixed with adhesive, but after this the patient became hypotensive and a perforation was found in the left atrium via an echocardiogram.A pericardiocentesis was performed and the patient was stable when the case was cancelled.The physician alleges the issue was due to the bad performance of the system.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3 one ensite precision patient reference sensor was received for evaluation.Visual inspection revealed the prs connector was free of physical damage and the 3 green caps were all secured.Visual inspection revealed that the wire insulation was cut and exposed the internal parts of the sensor 1 cable.The reported event was not able to be duplicated.The cable was visually noted to be physically damaged prior to return.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 investigation and information provided to abbott, the reported event was not able to be confirmed as the device functioned as intended.

• Brand Name: ENSITE X EP SYSTEM PATIENT REFERENCE SENSOR 3
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15651259
• Report Number: 2184149-2022-00255
• Device Sequence Number: 14943758
• Product Code: DQK
• UDI-Device Identifier: 05415067033291
• UDI-Public: 05415067033291
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ENSITE-PRSBACK-01
• Device Catalogue Number: ENSITE-PRSBACK-01
• Device Lot Number: 7603443
• 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: 10/14/2022
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2020
• 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 EP SYSTEM DISPLAY WORKSTATION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown