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 04/02/2024

Event Type  Injury  

Manufacturer Narrative

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 flutter left (l-afl) ablation with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced a pericardial effusion that required pericardiocentesis.After mapping in the right atrium with the octaray catheter, a transseptal procedure was performed.The vizigo sheath and octaray catheter went into the left atrium to map.The octaray catheter was switched with the thermocool® smart touch® sf bi-directional navigation catheter.Before any radio frequency (rf) delivery, a large effusion under the right ventricle was noticed on the intracardiac echo (non-bwi ice catheter).The physician began ablating in the left atrium, monitoring the effusion for ten minutes.It continued to grow, so the ablation was stopped, protamine was given to reverse heparin effect.The patient's blood pressure dropped from 120 to 80 systolic, supported by norepinephrine from anesthesia.A pericardiocentesis was performed and 500 ml of fluid was removed.The patient's blood pressure stabilized and ice images prior to catheter removal, as well as transthoracic echo images, revealed no residual effusion.The drain was removed prior to patient transport to the critical care unit (ccu) for observation.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

• 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: 19192747
• MDR Text Key: 341160167
• Report Number: 2029046-2024-01376
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: Other
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• 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: NON-BWI ICE CATHETER; UNK_CARTO VIZIGO SHEATH; UNK_OCTARAY NAV
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization