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 Tamponade (2226)

Event Date 11/15/2023

Event Type  Injury  

Manufacturer Narrative

E1.Initial reporter facility name: (b)(6).The bwi product analysis lab received the device for evaluation on 07-dec-2023.The 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.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure using thermocool® smart touch® sf bi-directional navigation catheter and experienced a cardiac tamponade which required a pericardiocentesis.At the end of the case, there was a reduction in blood pressure.An intracardiac echo (ice) was used and it was discovered that the patient experienced a pericardial effusion that required pericardiocentesis and about 200ml of blood was aspirated.Physician believes it was from a steam pop.The last known patient status during the initial call was that the patient was stable.Additional information was received.The transseptal puncture was performed with the baylis versacross needle (ref: vxsk0022, lot: vxf060723e).The patient fully recovered.Patient required extended hospitalization (overnight stay).No evidence of steam pop.The physician¿s opinion on the cause of this adverse event was that it was procedure related.The physician did not hear an audible pop during radio frequency (rf), and indicated at no point during the procedure that he physically felt a pop on the ablation catheter.There was no indication of an impedance spike on the generator.However, the physician felt that due to the small size of the left atrium and how much difficulty he had manipulating the catheter, that the only cause of the effusion could¿ve been a steam pop.Generator parameters include: power control mode (temperature cut-off 40c) (impedance cut-off 250 ohms, spike cut-off 40 ohm/0.5s, min.Cut-off 50 ohms).No errors were reported by any bwi systems.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation ablation procedure using thermocool® smart touch® sf bi-directional navigation catheter and experienced a cardiac tamponade which required a pericardiocentesis and prolonged hospitalization.The device evaluation was completed on 18-dec-2023.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 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.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 believes it was from a steam pop, however, he didn¿t hear an audible pop during rf, and indicated at no point during the procedure that he physically felt a pop on the ablation catheter.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: 18320298
• MDR Text Key: 330398655
• Report Number: 2029046-2023-02946
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• 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: 31123329L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2023
• 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: BAYLIS VERSACROSS NEEDLE; SMARTABLATE GENERATOR KIT-US; UNK PUMP; UNK_CARTO 3
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 62 KG