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

Model Number D134805

Device Problems Device Contamination with Body Fluid (2317); High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Paralysis (1997)

Event Date 07/05/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered phrenic nerve paralysis.Steam pop and thrombus occurred during roof ablation; impedance was increased.After the ablation catheter was removed from the patient¿s body, the physician checked it and confirmed thrombus attached on the catheter.The blood clot located was located on electrode tip.The catheter was used as is after removal of the thrombus on the catheter and flushing it.Additionally, phrenic nerve paralysis occurred during superior vena cava (svc) ablation; ablation was performed with confirming the twitching.Twitching could be confirmed up to the 5th beat, but it suddenly became impossible to be confirmed at the 6 ¿ 7th beat.The case was completed without any problems except for the steam pop, thrombus, and phrenic nerve paralysis.The physician's judgment on health injury is that it was non-serious (moderate/minor).Causality with product is unknown.Comment from physician is that there was no abnormality with the product.No abnormalities were observed during use of the product.The patient outcome of the adverse event is improved.Pictures not available.The product will be returned for analysis.No servicing need for generator/pump equipment.Mapping system used was carto3.The sheath was a vizigo.Thrombus: imp increased during roof ablation.Thrombus was attached to the catheter¿s tip electrode.Steam pop occurred when the roof ablation.Phrenic nerve palsy occurred during svc ablation, ablation was performed with confirming the twitching.Twitching could be confirmed up to the 5th beat, but it suddenly became impossible to be confirmed at the 6 ¿ 7th beat.Act was about 300 ~ 400.The patient¿s hospitalization was not extended.There was no neurological symptom was confirmed.Causes - thrombus: catheter floated due to respiratory fluctuation.Pop: increase in cf due to respiratory fluctuations.Phrenic nerve palsy: although twitching confirmed by pacing, but the event occurred.We the physicians are considering whether to lower the output power from the next time (in this procedure, the setting was 40 w).Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On 9-aug-2022, bwi received additional information regarding the event.The physician¿s opinion on the cause of this adverse event the physician considered the cause as follows: thrombus: floating of catheter due to respiratory fluctuation, steam pop: increased contact force due to respiratory fluctuations and phrenic nerve paralysis: although the procedure was performed while confirming twitching with pacing, phrenic nerve paralysis occurred.We are considering whether the output should be reduced in the future.In this case, 40 w was used.The patient was discharged without prolonged hospitalization.The patient had no neurological symptoms.The patient outcome of the adverse event was improved.The blood clot was located on the tip of the electrode.The system did not present any error messages and the physician/user did not experience any product problem.There were no issues related to temperature and flow on the act was maintained throughout the case at 300-400 sec.The generator used was a smartablate generator.No neurological symptom were observed.The correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation.The duration of ablation was under 30sec.The contact force momentarily exceeded 25g.Not exceeded 40g.Irrigation was pre 2sec, post 2sec.Heparinized normal saline was used as the irrigation fluid.The visitag module was used with the following settings respiration, setting, stability range, stability time, force over time, & tag size at fot 5g/90%, stability 2mm 3sec.On 18-aug-2022, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 7-sep-2022, the product investigation was completed.It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered phrenic nerve paralysis.Device evaluation details: visual analysis revealed that no damage or anomalies on the device.Per the event, several tests were performed.The magnetic, electrical, temperature and force features were tested and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device 30749532l number, and no internal action was found during the review.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The root cause of the adverse event remains unknown.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15143548
• MDR Text Key: 297037315
• Report Number: 2029046-2022-01759
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2022

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: 04/19/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30749532L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 08/02/2022
• Supplement Dates Manufacturer Received: 08/09/2022; 09/07/2022
• Supplement Dates FDA Received: 08/30/2022; 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; CARTO VISITAG MODULE; LASSO NAV; PENTARAY NAV ECO; VIZIGO SHEATH
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Male