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

Model Number D134804

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Date 04/12/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac perforation requiring pericardiocentesis.It was reported that there was a suspected cardiac perforation and there is a cardiac tamponade.They stated that when the physician was ablating near the carina and was heading towards the left atrial appendage in the left veins the patient became tachycardic.The patient's heart rate was 120-130.The physician stopped ablating when they noticed that the patient was tachycardic and called for a "tap kit".A pericardiocentesis was performed, and an unknown amount of fluid was removed.They stated that the patient was on ecmo and the intervention is still ongoing.They did confirm that the patient was stable at this time.They stated that the physician did not check if there was an effusion present pre-procedure.The reporter called back and stated that they had previously mispoken and wanted to clarify that the patient was not on ecmo.They also confirmed that the patient is now stable and they're in the intensive care unit (icu) for observation.Additional information was later received indicating the adverse event was discovered during ablation of the left pulmonary veins shortly after ablation of the cavotricuspid ishmus (cti) line and transseptal.The physician¿s opinion was reported as pretty confident that the perforation was caused during transseptal while using the versacross.He believes he tore the posterior wall when going transseptal.Transseptal puncture performed with baylis versacross rf transseptal needle.Prior to noting the effusion, ablation was performed.No evidence of steam pop noted.It is unknown when the perforation occurred ¿ physician thinks likely during transseptal but the effusion was found shortly after transseptal and while ablating the left pulmonary veins.There was a total of 76 ablation lesions and rf time of 00:22:01.Irrigated catheter was used in the event and the flow setting was standard thermocool® smart touch® sf bi-directional navigation catheter flow settings (high flow ¿ 8.15ml/min, low flow ¿ 2ml/min).Total irrigation = 797 ml.There was a sensor error noted on the octaray mapping catheter ¿ switched the cable and catheter and this error resolved prior to mapping the left atrium (la).No error messages were noted on ablation or any other bwi products.Force visualization features were graph, dashboard, vector, and visitag.Visitag module parameters for stability were (range; time; fot; tag size) range: 3mm, time: 3sec, force over time (for) 25% and 3g.No additional filter used with the visitag.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac perforation requiring pericardiocentesis.It was reported that there was a suspected cardiac perforation and there is a cardiac tamponade.They stated that when the physician was ablating near the carina and was heading towards the left atrial appendage in the left veins the patient became tachycardic.The patient's heart rate was 120-130.The physician stopped ablating when they noticed that the patient was tachycardic and called for a "tap kit".A pericardiocentesis was performed, and an unknown amount of fluid was removed.They stated that the patient was on ecmo and the intervention is still ongoing.They did confirm that the patient was stable at this time.They stated that the physician did not check if there was an effusion present pre-procedure.The reporter called back and stated that they had previously misspoken and wanted to clarify that the patient was not on ecmo.They also confirmed that the patient is now stable and they're in the intensive care unit (icu) for observation.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.The physician¿s opinion: the physician is pretty confident that the perforation was caused during transseptal while using the versacross.He believes he tore the posterior wall when going transseptal.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16900358
• MDR Text Key: 314887225
• Report Number: 2029046-2023-00984
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

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: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30974862L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 05/12/2023
• Supplement Dates FDA Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2023
• 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: BAYLIS VERSACROSS RF TRANSSEPTAL NEEDLE; CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-US; UNKNOWN PUMP; UNK_OCTARAY NAV
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male