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 Problem Cardiac Perforation (2513)

Event Date 01/05/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation ablation with a thermocool® smart touch® sf bi-directional navigation catheter and during ablation the patient experienced cardiac perforation that required pericardiocentesis and surgical intervention.First, the chest patch cable has been physically damaged, and also the patch has been not visible on the carto 3.This was before a pvi (pulmonary vein isolation) procedure.A spare cable had been used to manage to complete the case.Later, after the cable was replaced, the patient had a pericardial effusion (cardiac tamponade).Physician's opinion on the cause of this adverse event was procedure.Patient underwent surgery to stop the bleeding and required prolonged hospitalization.No steam pop occurred.There were no error messages observed on biosense webster equipment during the procedure.The tamponade occurred due to the physician causing a puncture to the pulmonary vein.After drainage, the patient stabilized and the physician continued ablation of the pulmonary veins.The issue caused a 14-minute delay to the procedure.The examination finished with no further complications.Afterward, the patient went to the imc station for monitoring (intermediate medical care).The patient fully recovered.

Manufacturer Narrative

E1 initial reporter phone: +41 43 253 78 85.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).

Manufacturer Narrative

On (b)(6) 2024, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an atrial fibrillation ablation with a thermocool® smart touch® sf bi-directional navigation catheter and during ablation the patient experienced cardiac perforation that required pericardiocentesis and surgical intervention.First, the chest patch cable has been physically damaged, and also the patch has been not visible on the carto 3.This was before a pvi (pulmonary vein isolation) procedure.A spare cable had been used to manage to complete the case.Later, after the cable was replaced, the patient had a pericardial effusion (cardiac tamponade).Device evaluation details: the device 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 number lot 31170206l 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.Physician's opinion on the cause of this adverse event was procedure.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
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18576079
• MDR Text Key: 333660362
• Report Number: 2029046-2024-00287
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P030031
• 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,Followup
• Report Date: 03/12/2024

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: D134805
• Device Lot Number: 31170206L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 01/24/2024
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2023
• 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-1 XS SERIES / G407209; CARTO 3 SYSTEM; NGEN RF GENERATOR; PENTARAY NAV ECO 7FR, F, 2-6-2; THMCL SMTCH SF BID, TC, D-F; UNK PUMP
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention