MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY¿ DWS7 V.5.0.1; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 100149275

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Cardiac Perforation (2513)

Event Date 05/25/2022

Event Type  Injury  

Event Description

Related manufacturing ref: 3008452825-2022-00473, 3008452825-2022-00473.During an atrial fibrillation procedure for a planned pulmonary vein isolation, a cardiac perforation occurred.Two sheaths were inserted over the right groin and a diagnostic catheter was then inserted into the coronary sinus (cs).A double transseptal puncture was completed successfully the needle and an advisor hd grid catheter was placed in the left atrium via the sheath.Cardioversion began to convert atrial fibrillation to sinus rhythm successfully.After collecting respirational data and switching the positional reference from the system reference to cs 3 reference, a peak-to-peak-map of the left atrium was done.No issues were noted with the system or catheters at that point.The hd grid catheter seemed a little off; a kink was visualized between the shaft and the adjacent electrodes a4-b4-c4 and d4 in the navx mapping system.However, this was thought to be a problem with the sheath filter, so the sheath filter baseline was reset.The issue occurred again, however, mapping continued with collect map-and model information.In the end, a proper map of the left atrium was completed and all four pulmonary veins were visible that needed to be ablated.The hd grid catheter was removed from the agilis sheath and inserted into an sl0 sheath.The ablation catheter was advanced via the agilis sheath.The force value on the ablation catheter was high prior to insertion into the patient (approximately 380 grams) but the force was reset to zero without any issues.As soon as the ablation catheter was inserted and advanced to the left atrium, both the hd grid and ablation catheters shifted approximately 7 mm and they were moving in the empty space above the model.A shadow was added after choosing cs positional reference and the catheter was right on that shadow; no shift was noted.The physician then decided to place the hd grid catheter in the left atrial appendage (laa) and the ablation catheter in the left superior pulmonary vein (lspv) via fluoroscopy.Both catheters were approximately 1cm above that position in the mapping system.The enguide alignment tool was used by setting the positional reference to system reference and then moving the cs catheter to the real position of the catheters.Ablation was then started, however the catheters shifted again without any visible cause.High force metrics were noted almost the whole time.The physician didn't actually know where his catheter position was due to the shift.A few unsuccessful ablations were done at the ostium of the lspv, but no matter how long ablation was done, there was still signal conduction through the tissue.The decision was made to stop the procedure to avoid further risks for the patient.After removing the catheters, an ultrasound was done which revealed a cardiac tamponade.A pericardiocentesis was performed which stabilized the patient.The patient was transferred to the icu and the nursing staff noted the patient wasn't able to move his left arm and left leg properly.The patient stated he had no strength in his arm or leg.A ct was then done which confirmed there was no stroke.The patient was able to move his limbs properly after the last examination.The physician indicated the incorrect depiction of the catheters in the navx mapping system, may have been one possible reason for the cardiac tamponade.

Manufacturer Narrative

Additional information: d4, h4.

Manufacturer Narrative

The results of the investigation are inconclusive as the device was not returned for analysis.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 received, the cause of the reported cardiac perforation remains unknown.

• Brand Name: ENSITE VELOCITY¿ DWS7 V.5.0.1
• 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: 14643342
• MDR Text Key: 293626092
• Report Number: 2184149-2022-00144
• Device Sequence Number: 1
• Product Code: DQK
• 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,Followup
• Report Date: 02/13/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 100149275
• Device Lot Number: 6421466
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 05/25/2022; 01/20/2023
• Supplement Dates FDA Received: 09/02/2022; 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2018
• 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: ADVISOR¿ HD GRID MAPPING CATHETER, SE; TACTICATH¿ ABLATION CATHETER, SE
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 75 KG