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 09/13/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a supraventricular tachycardia (svt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced cardiac perforation that required pericardiocentesis.During svt (supraventricular tachycardia) case, during ablation phase, while in the right atrium of the heart, a perforation occurred with the thermocool® smart touch® sf bi-directional navigation catheter and a pericardial effusion was noticed.There was a slight drop in blood pressure and a tachycardia was noticed in the patient.The pericardial effusion was discovered and confirmed by intracardiac echocardiography (ice) and xray.Pericardiocentesis removed 530 cc's of fluid and the patient was reported to be in stable condition.The physician's opinion on the cause of this adverse event is that it was procedure related.The patient was reported to be fully recovered with no residual effects.Patient required extended hospitalization because of this adverse event.Force visualization features used were graph, visitag, vector and dashboard.Recommended parameters for stability were used.No additional filter used with the visitag.Color options used was "f'".Transseptal puncture was performed with baylis versacross needle.Ablation was performed prior to noting the pericardial effusion.There was no evidence of steam pop.Recommended flow settings used.Correct catheter settings were selected on the generator and the pump switched from low to high during ablation.No error messages observed on biosense webster equipment during the procedure.

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 ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a supraventricular tachycardia (svt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced cardiac perforation that required pericardiocentesis.During svt (supraventricular tachycardia) case, during ablation phase, while in the right atrium of the heart, a perforation occurred with the thermocool® smart touch® sf bi-directional navigation catheter and a pericardial effusion was noticed.There was a slight drop in blood pressure and a tachycardia was noticed in the patient.The pericardial effusion was discovered and confirmed by intracardiac echocardiography (ice) and xray.Pericardiocentesis removed 530 cc's of fluid and the patient was reported to be in stable condition.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.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 physician's opinion on the cause of this adverse event was the procedure.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).

Manufacturer Narrative

On (b)(6) 2023, 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 17876668
• MDR Text Key: 324988397
• Report Number: 2029046-2023-02235
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2023

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: D134805
• Device Lot Number: 31085906L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 10/11/2023; 10/23/2023
• Supplement Dates FDA Received: 10/12/2023; 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2023
• 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,; BAYLIS VERSACROSS NEEDLE; CARTO 3 SYSTEM; UNKNOWN GENERATOR; UNKNOWN PUMP; UNK_CARTO VIZIGO SHEATH
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Male