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

Catalog Number D132705

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Date 08/02/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure that included thermocool® smart touch¿ bi-directional navigation catheter.The patient experienced cardiac perforation that required auto-transfusion.Timing of adverse event: before the use of bwi products.Description of health hazard: atrial fibrillation procedure.1 hour after completing the transseptal puncture and when the anatomical map was still being completed with the mapping catheter the patient blood pressure dropped as seen on anesthetics machine.The transoesophageal echocardiography (toe) indicated an effusion.Patient was treated for effusion and case cancelled.No radiofrequency (rf) was applied.Dr confirmed perforation must have occurred during transseptal puncture.Cartoreplay was checked and there was no evidence of high force on mapping catheter or any indication of catheter being pushed against atrial wall.Surgery was delayed due to the event.Case was cancelled.Procedure was not successfully completed.Patient stable.Patient consequence description: tamponade, auto-transfusion.No other medical intervention was required, patient had effusion and auto-transfusion was done.Patient stable.Date of adverse event: (b)(6) 2023.Physician's opinion on the cause of this adverse event: procedure, transseptal puncture (not bwi products used for transseptal).The patient did not require extended hospitalization.Thermocool smarttouch was used.Force visualization features used: graph, dashboard, vector, visitag.Parameters for stability: default, 3mm 3sec.Additional filter used with the visitag was force over time (fot) 25% min force 3g ablation index 450 and 380.Transseptal puncture was used with brk needle.Ablation was performed prior to noting the pericardial effusion.No evidence of steam pop.The event occurred during transseptal phase but only noted during ablation phase.Irrigated catheter flow settings included default smarttouch thermocool settings.Additional filter used with visitag was only ablation index target value.Color options used were ablation index.Note, no ablation was applied during this case.Catheter was only used to create geometry.No ablation was applied during this case.Catheter was only used to create geometry.Generator information: smartablate generator g4c-3845.Although ablation was not performed, it was noted that the ablation catheter was used " to create geometry" and the adverse event occurred during mapping.Thus, this adverse event is being captured on the ablation catheter.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.

Manufacturer Narrative

E1 initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30990524m 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.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¿ 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: 17671079
• MDR Text Key: 322514956
• Report Number: 2029046-2023-01980
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P030031/S053
• 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
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D132705
• Device Lot Number: 30990524M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2023
• 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: BRK NEEDLE; CARTO 3 SYSTEM; CARTO VISITAG MODULE; LASSO NAV CATHETER; SMARTABLATE GENERATOR
• Patient Outcome(s): Required Intervention; Life Threatening