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

Catalog Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pleural Effusion (2010); Cardiac Tamponade (2226)

Event Date 09/05/2023

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf).The patient suffered cardiac tamponade and pleural effusion requiring a pericardiocentesis and prolonged hospitalization.It was reported that during an idvt case, a pericardial effusion was noticed when ablating in the left ventricle of the heart.The patient's blood pressure slowly decreased with no changes to the impedance, and no other patient symptoms.The pericardial effusion was discovered when the physician swept the soundstar catheter in the left ventricle.The pericardial effusion was confirmed by intracardiac echocardiography (ice) and fluoroscopy.The medical intervention provided was a pericardiocentesis and 500 ml of fluid was removed.The patient was reported to be in stable condition.They reported that the physician believed the effusion was "when he went transeptal through the left atrium and tried to go into the mitral valve and the hook under the mitral valve".Additional information was received.It was reported that the adverse event was discovered during use of biosense webster products.Physician believed that it occurred when he was looping the catheter through the mitral valve and applying force to get the ablation catheter to the pvc location in the left ventricle.Therefore, the physician¿s opinion was that it was procedure related.Patient required extended hospitalization because of the adverse event as patient was in-patient in the hospital for 4-5 days post procedure due to infiltrates in her lungs and increased oxygen demands.Physician suspected the patient aspirated during the pericardial effusion.The patient¿s condition improved.Relevant tests/laboratory data- no relevant tests other than acts every 15 minutes to check coagulation.Transeptal was performed with an abbott brk.Prior to noting the pericardial effusion, ablation was performed.There was no evidence of a steam pop.The event occurred during the mapping/ablation phase.Low flow setting was on for the stsf catheter.Correct catheter settings were selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.No error codes observed during procedure.Graph, dashboard, vector, and visitag were used.Visitag module was used, parameters for stability used was 2mm, 3 seconds, 25% over 3 sec, 2mm tag.No additional filter used with the visitag.Color options used prospectively was force.

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 04-oct-2023.The device evaluation was completed on 12-oct-2023.It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf).The patient suffered cardiac tamponade and pleural effusion requiring a pericardiocentesis and prolonged hospitalization.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.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 (mre) was performed for the finished device 31089516l number, and no internal action related to the complaint was found during the review.Based on the completed mre, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated with appropriate information.No malfunction was observed during the product analysis.The physician believed that it occurred when he was looping the catheter through the mitral valve and applying force to get the ablation catheter to the pvc location in the left ventricle.Therefore, it was believed to be procedure related.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported.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.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: 17830888
• MDR Text Key: 324431869
• Report Number: 2029046-2023-02179
• 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: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31089516L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2023
• 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: ABBOTT BRK NEEDLE; SMARTABLATE GENERATOR KIT-US; SOUNDSTAR ECO SMS 8F CATHETER; UNK_CARTO 3
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 76 KG