MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ X EP SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ENSITE-SYSTEM-01

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/26/2022

Event Type  Injury  

Event Description

Following an atrial fibrillation procedure using navx mode on the ensite x system, the patient developed pulmonary hemorrhage experiencing hemoptysis.During the procedure there was excessive movement with the ablation and cs catheters.The hd grid catheter was stable throughout.Respiration compensation was applied several times throughout the procedure in attempt to decrease the catheters movement without success.Due to the catheter movement the physician believes he may have ablated to deep into the pulmonary veins resulting in the hemorrhage.He also stated the patient was intubated, but insertion trauma to the esophagus was not examined.An esophageal probe was not used for the procedure.The patient had a ct scan and was followed up in clinic with no further issues noted.The physician stated the cause for the pulmonary hemorrhage was unknown but intubation trauma nor the ensite system could be ruled out.

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 reported incident could not be conclusively determined.If a shift occurs, it is recommended to use enguide alignment to return the catheters to their previous positions relative to the model.

• Brand Name: ENSITE¿ X EP SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14803464
• MDR Text Key: 295058269
• Report Number: 2184149-2022-00155
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-SYSTEM-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 70 KG