MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D132705

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

Patient Problems Cardiac Arrest (1762); Vasoconstriction (2126); No Code Available (3191)

Event Date 06/03/2019

Event Type  Injury  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 6/11/2019.Initial visual analysis observed there was no physical damage.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.A manufacturing record evaluation was performed for the finished device 30188255m number, and no internal actions related to the reported complaint condition were identified.(b)(4).

Event Description

It was requested that a (b)(6) male patient ((b)(6)) underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and suffered cardiac arrest (requiring chest compressions and surgical intervention) and arterial spasm.During the procedure, about 15-20 minutes after ablation was completed, the patient went into cardiac arrest and his heart rate stopped.The certified registered nurse anesthetist (crna) mentioned the blood pressure dropped.No pulse was discovered near the groin area.The issue was confirmed by arterial line pressure and respiratory gauging.Chest compressions were provided for about 1 hour, and an impella device and a temporary pacemaker were placed in to regain stability.The patient was reported in stable condition with a blood pressure of 140/70, some neurological functions were confirmed.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition related, physician stated the spasms on the coronary artery were due to not getting enough blood flow to the heart.Patient¿s condition was not much changed when we left the case.Patient was having to rely on the impella device on top of pacing from the external pacemaker.Extended hospitalization was required as a result of the event, the patient is still currently in the intensive care unit (icu).No bwi product malfunctions were reported.The sheath used was a st.Jude medical sl1 sheath (non-bwi product).

Manufacturer Narrative

It was requested that a 74-year-old male patient (104kg) underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and suffered cardiac arrest (requiring chest compressions and surgical intervention) and arterial spasm.During the procedure, about 15-20 minutes after ablation was completed, the patient went into cardiac arrest and his heart rate stopped.The certified registered nurse anesthetist (crna) mentioned the blood pressure dropped.No pulse was discovered near the groin area.The issue was confirmed by arterial line pressure and respiratory gauging.Chest compressions were provided for about 1 hour, and an impella device and a temporary pacemaker were placed in to regain stability.The patient was reported in stable condition with a blood pressure of 140/70, some neurological functions were confirmed.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition related, physician stated the spasms on the coronary artery were due to not getting enough blood flow to the heart.Device evalatuion details: the device evaluation has been completed.The device was visually inspected and it was found in good conditions.The magnetic sensor was tested on carto and the catheter was properly visualized and no errors were observed.Then, the force sensor was tested and it was working properly, the force values were observed within specifications.Then, electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Then, the irrigation and deflection test were performed and it was found within specifications, the catheter was irrigating and deflecting correctly.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The catheter passed all specifications.The root cause of the adverse event remains unknown.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition related.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.Correction: it was noticed that the concomitant device was inadvertently omitted from the 3500a initial mdr.The field d11.Concomitant products has now been populated.Manufacturer's ref # pc-000475352.

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8734630
• MDR Text Key: 149206440
• Report Number: 2029046-2019-03328
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

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: 03/04/2020
• Device Catalogue Number: D132705
• Device Lot Number: 30188255M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 06/26/2019
• Supplement Dates Manufacturer Received: 07/07/2019
• Supplement Dates FDA Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ST..JUDE MEDICAL SL1 SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 104