MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134804

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/14/2023

Event Type  Injury  

Manufacturer Narrative

Biosense webster manufacturer's reference number (b)(4) has 2 reports.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 31135067l number, and no internal action related to the complaint was found during the review.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/fibrillation ablation procedure using thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced cardiac tamponade and cardiac arrest that required pericardiocentesis and cpr.The patient also developed a groin hematoma while using the vizigo sheath.After mapping the right atrium it was determined that the flutter was left-sided, so a single transseptal procedure was performed.The physician mapped with octaray and then ablated with the stsf catheter in the left atrium, performing a pulmonary vein isolation and posterior wall ablation.After this, the mechanism of the flutter changed so the stsf catheter was removed with the intention of using the octaray catheter to further map in the la (left atrium).At this time a large groin hematoma was noticed at the vizigo sheath insertion site, so the physician removed the octaray, and retracted the vizigo sheath back into the ra (right atrium).Also at this time, no pulse could be detected on the patient and there were blood pressure changes (unspecified).The ablation procedure was aborted and the patient received cpr.Echocardiogram (echo) confirmed pericardial effusion and cardiac tamponade findings.A detectable pulse returned to the patient after pericardiocentesis and blood pressure stabilized, and the ra "re-inflated." patient was transferred to icu with a chest tube in place and single, groin access sheath remained.The patient was stable.It was reported that the patient had preexisting structural heart issues, an enlarged la, mitral valve regurgitation, and a "floppy" septum.The physician was uncertain of the cause of the pericardial effusion, and at what point in the procedure the effusion occurred, whether at transseptal access, ablation in the left atrium, or when seeing higher force readings while maneuvering the catheter and vizigo sheath.No evidence of steam pop.No error messages appeared on biosense webster equipment during the procedure.Physician stated that his opinion on the adverse event was occasional high force from sheath use along with the patient's own anatomy.The patient required extended hospitalization, recovered in the icu, and was discharged a few days later than usual due to increased recovery and monitoring time.The patient fully recovered.This report is for the thermocool smarttouch.The hematoma was reported in a separate report for the vizigo sheath.

• 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: 18303706
• MDR Text Key: 330189039
• Report Number: 2029046-2023-02905
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134804
• Device Lot Number: 31135067L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2023
• 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: CARTO 3 SYSTEM WITH VISITAG; NGEN GENERATOR; OCTARAY CATHETER; VERSACROSS TRANSSEPTAL NEEDLE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 70 KG