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

Model Number D134702

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

Patient Problem Cardiac Tamponade (2226)

Event Date 11/29/2019

Event Type  Injury  

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab (pal) received the complaint device for evaluation on 12/18/2019.Initial visual analysis observed there was no visual damage or anomalies.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.Additionally, if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that an (b)(6)-year-old male patient underwent a left sided atrial tachycardia ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.During the ablation phase, there were three steam pops in the left atrium, anteroseptal.During the first ablation after 20 seconds the first steam pop occurred.Tachycardia was terminated during ablation.However, the anterior line was not fully completed, because the patient had a sudden drop in blood pressure due to cardiac tamponade.Percutaneous pericardiocentesis was performed and 680 ml of blood was extracted.The case was cancelled.Extended hospitalization of three days was required.Physician¿s opinion on the cause of the event is that it was product malfunction related because all other ablation parameters did not indicate inappropriate catheter use.Images provided by the customer showed no abnormal readings except impedance spikes characteristic of steam pop.Transseptal puncture was performed with an abbott brk 1 needle.The power was 30-40w, maximum force 40g, maximum impedance 150ohm, flow setting for less than 30w 8ml and greater than 30w 15ml.Graph, dashboard, vector, visitag force visualization features were used.Visitag parameters were range 3mm, time 3 seconds, force over time 25% 3g, tag size 3mm and ablation index color option.No additional visitag filters were used.There was no error messages observed on biosense webster equipment during the procedure.

Manufacturer Narrative

It was reported that an 80-year-old male patient underwent a left sided atrial tachycardia ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.During the ablation phase, there were three steam pops in the left atrium, anteroseptal.During the first ablation after 20 seconds the first steam pop occurred.Tachycardia was terminated during ablation.However, the anterior line was not fully completed, because the patient had a sudden drop in blood pressure due to cardiac tamponade.Percutaneous pericardiocentesis was performed and 680 ml of blood was extracted.The case was cancelled.Extended hospitalization of three days was required.Physician¿s opinion on the cause of the event is that it was product malfunction related because all other ablation parameters did not indicate inappropriate catheter use.On 1/8/2020, biosense webster inc.Received additional information which indicates the physician was monitoring the temperature using the graph viewer in carto 3 system and the ep recording system.Correction: it was noticed the concomitant products were inadvertently missed in section d11.Concomitant med.Product section in the 3500a initial medwatch report.The devices have now been added.Device evaluation details: on 1/15/2020, the device evaluation was completed.The device was visually inspected and it was found in good conditions.The magnetic, temperature and force features were tested and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.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.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The customer had also provided screenshot images of the procedure; however, no result could be obtained from the images and therefore the customer complaint could not be confirmed from the images.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref # (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: 9505113
• MDR Text Key: 188854477
• Report Number: 2029046-2019-04049
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/29/2019

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: 08/15/2020
• Device Model Number: D134702
• Device Catalogue Number: D134702
• Device Lot Number: 30266097L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BRK 1 NEEDLE FROM ABBOTT; CARTO 3 SYSTEM; EP RECODING SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 80 YR