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 03/04/2024

Event Type  Injury  

Manufacturer Narrative

On 20-mar-2024, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced cardiac perforation that required medication and prolonged hospitalization.It was reported by the caller that during a procedure an adverse event occurred.A pericardial effusion caused by a perforation was discovered using intracardiac echocardiography (ice).They confirmed the effusion using an x-ray, echocardiogram, and another cardiologist's assessment.The medical intervention provided was medication administration and the patient was moved to the intensive care unit to be monitored.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced cardiac perforation that required medication and prolonged hospitalization.It was reported by the caller that during a procedure an adverse event occurred.A pericardial effusion caused by a perforation was discovered using intracardiac echocardiography (ice).They confirmed the effusion using an x-ray, echocardiogram, and another cardiologist's assessment.The medical intervention provided was medication administration and the patient was moved to the intensive care unit to be monitored.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation and the product evaluation was completed on 2-apr-2024.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 batch number, and no internal actions were identified.No malfunction was observed during the product analysis.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 ref.# (b)(4) correction: on 29-mar-2024, it was discovered the following information was inadvertently omitted from the 3500a initial medwatch report: ¿the physician¿s opinion on the cause of the adverse event is that it was procedure related.Transeptal puncture was performed with a baylis needle.Ablation was performed prior to noting the pericardial effusion.There was no evidence of steam pop.No error messages observed on biosense webster equipment during the procedure.Correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation.¿ in addition, the initial reporter details and additional concomitant product details were also omitted, as such, they have now been added to the respective fields.

• 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: 18984304
• MDR Text Key: 338660735
• Report Number: 2029046-2024-01030
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• 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: 31233473L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2024
• 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: BAYLIS TRANSSEPTAL NEEDLE; CARTO 3 SYSTEM; DECANAV CATHETER: 31229799M/ REF: R7D282CT; ICE CATHETER; UNKNOWN GENERATOR; UNKNOWN PUMP; VIZIGO SHEATH
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Male