MAUDE Adverse Event Report: ST. JUDE MEDICAL ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number D-AVHD-DF16

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Death (1802); Pleural Effusion (2010); Cardiac Perforation (2513)

Event Date 08/30/2019

Event Type  Death  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.Further information regarding the event were requested but not received.

Event Description

Related manufacturer reference: 3005334138-2019-00523.During a ventricular tachycardia ablation procedure, a cardiac tamponade, cardiac arrest and subsequent death occurred.While attempting epicardial access, a pleural effusion was confirmed on ice at the rv apex, suggestive perforation from the pajunk needle.Epicardial access was confirmed with dye visualized layering around the pericardial space.A wire was then advanced and observed to curl in the epicardial space without advancing beyond the cardiac silhouette.An agilis sheath was then advanced over the wire into the pericardial space.A second wire was advanced into the epicardium.The agilis was removed and advanced over one of the wires.The wire and dilator were from the agilis and the remaining wire was secured to the drape.Approximately 290 cc of blood was removed from the pericardial space.The effusion did not reaccumulate and was closely monitored during the procedure.A coronary angiogram was completed afterwards.Following the ablation, the patient became hypotensive.Blood was visualized in the pericardial space.Chest compressions were initiated.A chest tube was placed and a blood was removed.The bleeding did not slow and ct surgery was called for ecmo.The rhythm degenerated and the patient was shocked multiple times throughout.Sinus rhythm could not be restored.Surgery was performed and biv pacing was finally restored after heart paddle shock.Direct visualization of the heart showed the left-sided chest tube was puncturing the lv.The chest tube was removed and the myocardium was stitched.Bleeding could not cease and resusitive efforts were abandoned and the patient expired.It was noted the patient was high-risk with comorbitities that contributed to the sequence of events.There were no performance issues with any abbott device.It should be noted that two days prior to the ablation procedure, there was a staged procedure and a pneumothorax occurred.

Event Description

Related manufacturer reference: 2182269-2019-00170.During a ventricular tachycardia ablation procedure, a pleural effusion, cardiac arrest and subsequent death occurred.

Manufacturer Narrative

The device was returned due to a pleural effusion, cardiac arrest and patient death.Electrodes 1-18 and the sensors met specifications for acceptable resistance values with no open or short circuits detected.The catheter was manually flushed with no anomalies noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported pleural effusion, cardiac arrest and death remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9077446
• MDR Text Key: 158848768
• Report Number: 3005334138-2019-00524
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K172393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2019

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 Expiration Date: 04/30/2022
• Device Model Number: D-AVHD-DF16
• Device Lot Number: 6990778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2019
• Initial Date FDA Received: 09/17/2019
• Supplement Dates Manufacturer Received: 09/25/2019; 10/18/2019
• Supplement Dates FDA Received: 09/25/2019; 10/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AGILIS¿ INTRODUCER; FLEXABILITY¿ ABLATION CATHETER, SE; FLEXABILITY ABLATION CATHETER, SE
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Weight: 129