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

Model Number ENSITE-PRSBACK-01

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Cardiac Perforation (2513)

Event Date 10/14/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 302191825
• Report Number: 2184149-2022-00255
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067033291
• UDI-Public: 05415067033291
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K202066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ENSITE X EP SYSTEM DISPLAY WORKSTATION
• Patient Outcome(s): Required Intervention