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

Catalog Number BN7TCDF4L

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 03/22/2024

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 ref.# (b)(4).

Event 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.

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.

• Brand Name: EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER
• Type of Device: 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
• MDR Text Key: 340340227
• Report Number: 2029046-2024-01268
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: 10846835002997
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990025/S12
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2024
• 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: 4MM NAVIGATIONAL BI-DIRECT; CARTO 3 SYSTEM; SMARTABLATE RF GENERATOR; UNKNOWN RECORDING SYSTEM
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Female