MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Catalog Number	BN7TCDF4L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	03/22/2024
Type of Reportable Event	Serious Injury
Additional 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).
Event or Problem Description
It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a ez steer¿ nav bi-directional electrophysiology catheter and during the ablation phase, the patient experienced cardiac tamponade that required pericardiocentesis.First it was reported that the distal electrode on the ez steer¿ nav bi-directional electrophysiology catheter was blacked out on the carto® 3 system and the distal signal had a lot of noise displayed on both carto® 3 and recording systems.The cable was replaced without resolution.The ez steer¿ nav bi-directional electrophysiology catheter was replaced and the issue was resolved.The case continued.The signal interference (noise) was observed on ic, bs, or all ecg (bs + ic) channels just on ablation distal.The physician had intact ecg signal available to monitor the patient's heart rhythm.The customer¿s reported noise issue is not considered to be mdr reportable since the risk to the patient is low.It was also reported that during ablation with the second ez steer¿ nav bi-directional electrophysiology catheter, a steam pop was heard.There was no rise in the impedance and ablation stopped.An impedance spike was noticed after coming off ablation.The physician stopped and noticed that the patient was braidy down.Echo was performed, and a pericardial effusion was noticed.Medical intervention provided was a pericardiocentesis.The patient was reported to be in stable condition.Additional information was received indicating the physician's opinion on the cause of the adverse event is that it was procedure related.No transseptal puncture was performed.Generator parameters: settings were 55 degrees and 50w.No errors reported by the biosense webster systems.The patient has fully recovered but required extended hospitalization.
Additional Manufacturer Narrative
On 13-may-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.Additionally, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# pc-001571571.
Additional Manufacturer Narrative
It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a ez steer¿ nav bi-directional electrophysiology catheter and during the ablation phase, the patient experienced cardiac tamponade that required pericardiocentesis.It was reported a steam pop was heard.There was no rise in the impedance and ablation stopped.An impedance spike was noticed after coming off ablation.The physician stopped and noticed that the patient was braidy down.Echo was performed, and a pericardial effusion was noticed.Medical intervention provided was a pericardiocentesis.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.The temperature features values were found within the specifications.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 catheter instruction for use (ifu) states that: careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.When rf energy is interrupted for either a temperature or an impedance rise (the set limit is exceeded), the catheter should be removed, and the tip cleaned of coagulum.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).

• Brand Name: EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER
• Common Device Name: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• 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: 19122725
• Report Number: 2029046-2024-01268
• Device Sequence Number: 8283523
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: 10846835002997
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P990025/S12
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: BN7TCDF4L
• Device Lot Number: 31241306M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 05/13/2024; 05/20/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 05/14/2024; 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4MM NAVIGATIONAL BI-DIRECT.; CARTO 3 SYSTEM.; SMARTABLATE RF GENERATOR.; UNKNOWN RECORDING SYSTEM.
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Female