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

Catalog Number D134703

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Date 07/05/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an afib ¿ paroxysmal ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter (stsf).The patient suffered cardiac perforation requiring a surgical intervention and prolonged hospitalization.It was reported by the biosense webster inc.(bwi) representative that there was an issue with the ablation catheter (force vector).The physician stated that the vector was not "cooperating with him" like usual.He did not like the way the vector was projected.The catheter cable was replaced without resolution.The catheter was replaced, and the issue was not resolved.They continued the use of the second catheter for the case, and the ablation was successful as measured by voltage map and pacing maneuvers.They did not have further details regarding this issue at the time of the call.It was also reported that the patient suffered a pericardial effusion (pe).After transseptal access was lost, when attempting to go back transseptal, the physician believes the ablation catheter then caused a perforation.The effusion was discovered after ablation during a post-case routine intracardiac echcardiography (ice) scan.A pericardiocentesis was performed.The patient was stable at the time of the call.The adverse event was discovered post use of bwi products.The physician believed that a perforation may have been caused by manipulation of the ablation catheter when trying to re-obtain transseptal access.Transseptal puncture was performed with a baylis versacross.Prior to noting the pe, ablation was performed.There was no evidence of steam pop.The event occurred potentially during transseptal phase.Irrigated catheter was used in the event, the flow setting was stsf, per instructions for use (ifu) 8/15 ml.No error messages were observed on the biosense webster equipment during the procedure.The patient was hemodynamically stable at the time of reporting.There was a suspected perforation per the physician, it was confirmed with a soundstar.Pericardiocentesis was performed and fluid removed was 275- 300 ml.The tube was left in place.Procedure was not abandoned as ablation was already completed.There was an evidence of a small effusion present before the procedure, confirmed by transesophageal echocardiography (tee) pre-case.Outcome of the adverse event was improved.Patient required extended hospitalization because of the adverse event as there was trace effusion the next day per physician.Generator information was a stockert smartablate - f28f617.Correct catheter settings were selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.All force visualization features were used (graph, dashboard, vector, and visitag).Visitag module was used, parameters for stability used (range; time; fot; tag size) were- 3, 3, 25, 3 respectively.Additional filter used with the visitag was respiratory gated.Color options used prospectively was surpoint.The ablation catheter will be returned for analysis.No replacement was requested.They have both ablation catheters that were used.Not sure which is which, so both will be sent back.

Manufacturer Narrative

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 was performed for the finished device 30994735l number, and no internal actions related to the reported complaint condition were identified.No malfunction was observed during the product analysis.The physician believes that perforation may have been caused by manipulation of the ablation catheter when trying to re-obtain transseptal access.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.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).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: 17445136
• MDR Text Key: 320248158
• Report Number: 2029046-2023-01680
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009798
• UDI-Public: 10846835009798
• 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
• Report Date: 08/02/2023

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 Catalogue Number: D134703
• Device Lot Number: 30994735L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2023
• 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: 7FR DECAN,11P,D,2.4MMLE,282MM,; BI DIR 7FR DEFL CS CATH,NON-; OCTA,LNG,48P,3-3-3-3-3,D-CURVE; SOUNDSTAR ECO SMS 8F CATHETER; THMCL SMTCH SF UNID, TC, J; UNK BAYLIS VERSACROSS TRANSSEPTAL NEEDLE; UNK BRAND CABLE; UNK BRAND CABLE; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Female