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 01/24/2024

Event Type  Injury  

Manufacturer Narrative

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).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) -paroxysmal ablation with a thermocool® smart touch® sf bi-directional navigation catheter and at the end of ablation phase the patient experienced cardiac perforation that required pericardiocentesis.During the afib case, a pericardial effusion was noticed.There was a drop in blood pressure in the patient.The pericardial effusion was confirmed by an ultrasound machine using a soundstar catheter.The medical intervention provided was a pericardiocentesis.The patient was reported to be in stable condition and "will be incubated overnight." the physician was unsure of what caused the pericardial effusion.However, the cardiac perforation was confirmed.No bwi product malfunction was noted.Patient improved / fully recovered but did require an extended hospitalization.Transeptal puncture was performed.Ablation was performed prior to noting the pericardial effusion.No evidence of steam pop.No error messages observed on biosense webster equipment during the procedure.

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 (afib) paroxysmal ablation with a thermocool® smart touch® sf bi-directional navigation catheter and at the end of ablation phase the patient experienced cardiac perforation that required pericardiocentesis.During the afib case, a pericardial effusion was noticed.There was a drop in blood pressure in the patient.The pericardial effusion was confirmed by an ultrasound machine using a soundstar catheter.The medical intervention provided was a pericardiocentesis.The patient was reported to be in stable condition and "will be incubated overnight." the physician was unsure of what caused the pericardial effusion.However, the cardiac perforation was confirmed.No bwi product malfunction was noted.Patient improved / fully recovered but did require an extended hospitalization.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 31185633l number, 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 isn¿t sure what caused the pericardial effusion.No bwi product malfunction was noted.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: 18715901
• MDR Text Key: 335526787
• Report Number: 2029046-2024-00510
• Device Sequence Number: 1
• Product Code: LPB
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2023
• 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,F,2.4MMLE,282MM.; BAYLIS ENERGY NEEDLE.; CARTO 3 SYSTEM.; CREATED IN ERROR.; OCTA,LNG,48P,3-3-3-3-3,D-CURVE.; SMARTABLATE GENERATOR SN (B)(6).; UNK_SMARTABLATE PUMP.; UNK_SOUNDSTAR.
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Male