MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER¿ THERMOCOOL® BI-DIRECTIONAL CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number BDI75TCFJRT

Device Problems Signal Artifact/Noise (1036); Device Sensing Problem (2917); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 06/29/2023

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 reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial flutter ablation procedure with a ez steer¿ thermocool® bi-directional catheter.The patient suffered cardiac tamponade requiring a pericardiocentesis.A report was brought to bwi's notice: - date of event: (b)(6) 2023 - hospital name: (b)(6) hospital - brand name: bwi - product name: thermocool f-j curve - product code: 36q5jm - lot/batch/exp: 30993121m - the product was not being used in a clinical trial.- the event happened during a procedure.- they were not in the procedure at the time of the event.- surgery was prolonged due to the event.It was reported that during an atrial flutter ablation and a standard cti (cavotricuspid ishmus) line that there was noise seen on the proximal electrodes and impedance was deemed unreliable during ablation.There was a steam pop and unfortunately the patient experienced a tamponade, that required draining and surgical intervention.Customer provided operator¿s procedure notes below: elective admission for af/afl ablation ecgs with typical flutter was seen before came in af.Local anesthetic and sedation us guided rfv access.1x7 f sheath for cs (coronary sinus).1x8 f sheath then upgraded for torflex 45 degree.Patient in af (atrial flutter) at baseline dccv to sinus, underlying sinus bradycardia proceeded for cti line.A steam pop was heard during ablation at ct line.Blood pressure started to drop afterwards.Echo revealed a tamponade.Physician scrubbed in an inserted a pericardial drain.Blood pressure stabilized initially.Reversal with octaplex was given blood transfusion protocol was activated however, he kept draining (a total of 950 mls + 450 mls reinfused via the long sheath).Surgeons were called early and were monitoring the drainage.Decision was made to open chest as drain kept draining and bp (blood pressure) was borderline despite reversing anticoagulation.Patient was stabilized and sent to itu for monitoring.Additional information- physician¿s opinion on the cause of this adverse event was the patient condition the customer is not sure what the cause of adverse event was.He is not blaming the bwi product though.Outcome of the adverse event was that the patient had his chest opened during the procedure and a small hole was found in the right atrium and this was stitched by a surgeon.The patient has made a full recovery.Patient require extended hospitalization because of the adverse event because he required surgical intervention to close the hole cause by the steam pop.Other relevant history- just a standard elective atrial flutter ablation.Generator information was a smart ablate but need to get the serial number.No right atrial case.Irrigated catheter was used in the event, the flow setting was thermocool setting on sma.Correct catheter settings were selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.No error messages, just noise seen on the prox electrodes and impedance deemed unreliable by the customer.Non-nav case.The issue occurred during ablation.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious.Steam pop is not mdr-reportable.Impedance issue is not mdr-reportable.Noise issue is not mdr-reportable.

Manufacturer Narrative

On 3-aug-2023, the product investigation was completed.It was reported that a patient underwent an atrial flutter ablation procedure with a ez steer¿ thermocool® bi-directional catheter.The patient suffered cardiac tamponade requiring a pericardiocentesis.Device evaluation details: 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 number lot 30993121m and no internal actions related to the complaint were found during the review.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.Physician¿s opinion on the cause of this adverse event was the patient condition.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).

Manufacturer Narrative

On 1-aug-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: EZ STEER¿ THERMOCOOL® BI-DIRECTIONAL CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 17421830
• MDR Text Key: 320027984
• Report Number: 2029046-2023-01633
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835002898
• UDI-Public: 10846835002898
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BDI75TCFJRT
• Device Lot Number: 30993121M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• 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: SMARTABLATE GENERATOR; SMARTABLATE PUMP
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Male