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

Catalog Number	BN7TCFJ4L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	08/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrioventricular nodal re-entrant tachycardia (avnrt) ablation procedure that included ez steer¿ nav bi-directional electrophysiology catheter.The patient experienced cardiac tamponade that required pericardiocentesis and prolonged hospitalization.It was reported that while they were ablating, the monitoring nurse noticed the patient's blood pressure drop to 54 over 28 and immediately notified the anesthesiologist and the physician.They came off ablation and put in an arterial line and used a soundstar catheter and noted a pericardial effusion off the right ventricle.They then performed a pericardiocentesis and 400 ccs of fluid from the patient and monitored the patient with an intracardiac echo until the patient was stabilized.The procedure was canceled, and the patient was then sent to the intensive care unit to recover.It is unknown how long the patient stayed in the hospital.The patient was stable at the time of the call.Initially, the physician did not provide any opinion on what could have caused the issue as they had no errors and no high readings on any metric.Additional information was received, and it was reported that the physician's opinion on the cause of the adverse event was that it was procedure related as he thinks that it was due to the biosense diagnostic quad catheter he placed in the rv.Patient has fully recovered.Visitag module was used with parameters for stability of 2mm, 5 seconds, 3mm size tags, no fot.Color options used: time.No additional filter used with the visitag.The patient was in the room at the time of the cancellation.The patient was under general anesthesia for an unknown amount of time.No transseptal puncture was performed.In the physician's opinion, cancelation of the procedure did not contribute to a serious injury to the patient, just pericardial effusion.Ablation was performed prior to noting the cardiac tamponade.No evidence of steam pop.Correct catheter settings were selected on the generator.No error messages noted on the biosense webster equipment during the procedure.
Additional Manufacturer Narrative
The product 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.Physician's opinion on the cause of the adverse event was the procedure.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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).

• 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: 17662745
• Report Number: 2029046-2023-01956
• Device Sequence Number: 20609311
• Product Code: LPB
• UDI-Device Identifier: 10846835003031
• UDI-Public: 10846835003031
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 08/31/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2026
• Device Catalogue Number: BN7TCFJ4L
• Device Lot Number: 31075245M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• 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: DECANAV CATHETER; QUAD F-CURVE CATHETER; UNK GENERATOR; UNK_CARTO 3; UNK_SOUNDSTAR
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 60 KG