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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/09/2022

Event Type  Injury  

Manufacturer Narrative

An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device 30902820l number, and no internal action related to the complaint was found during the review.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a 59-year-old,male patient, weighing 247 lbs.Underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade (ct) requiring pericardiocentesis.It was reported by the bwi representative that while going epicardial in order to continue ablating the cavotricuspid isthmus (cti) line at the epicardial level, a pericardial effusion (pe) occurred.The pericardial effusion was verified by ultrasound.A pericardiocentesis was done and 377 ccs of fluid were removed to the best of the knowledge of the bwi rep.The bwi rep.Was asked to leave the room so that the effusion team could further address the issue.The patient was stable when they left the room.The patient did not require surgical repair.The procedure was aborted.The bwi rep spoke with the physician post-case briefly.The physician stated the patient will need to come back to perform an epicardial ablation at the site of interest at a later time.They had ablated the posterior inferior portion of the lateral wall of the left ventricle.The total watts used were 45 and 50 max.They used a decanav catheter, an stsf ablation catheter, a deflectable josephson quad catheter, and a soundstar catheter.Additional information was received on (b)(6) 2022.Clarification was received that the physician was going epicardial to further ablate after a endocardial vt ablation.Not a cti ablation.The adverse event occurred post use of biosense webster products, and prior to further ablation (epicardial).Physician¿s opinion on the cause of this adverse event was that it was procedure related.In the physician's opinion, the event occurred during the procedure -- to place the ablation catheter epicardially.The patient fully recovered (no residual effects).Patient did not require extended hospitalization because of the adverse event.No transseptal puncture performed.Ablation was performed prior to noting the pe or ct.There was evidence of a steam pop.The event occurred during the posterior lateral left ventricle ablation.Flow setting for the irrigated catheter used was low flow 2 ml/sec.Correct catheter settings was selected on the generator.Pump switched to "high" during ablation.No error messages observed on biosense webster equipment during the procedure.Force visualization features used were graph, dashboard, vector and visitag.Parameters for stability for the visitag module used was 3 mm, 3 sec, 3 g ; visitag size = 3mm.Additional filter used with the visitag was acuresp.Color options used prospectively were fti, average, force and time.

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 04-jan-2023.The device evaluation was completed on 06-jan-2023.It was reported that a 59-year-old, male patient, weighing 247 lbs.Underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade (ct) requiring pericardiocentesis.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.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 30902820l number, and no internal action related to the complaint 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.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 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15937962
• MDR Text Key: 305044717
• Report Number: 2029046-2022-03054
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30902820L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2022
• 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; UNK DECANAV; UNK DEFLECTABLE JOSEPHSON QUAD CATHETER; UNK GENERATOR; UNK_SOUNDSTAR
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 112 KG