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 Arrest (1762)

Event Date 06/30/2023

Event Type  Injury  

Manufacturer Narrative

E1 initial reporter phone: (b)(6).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 a reported that a patient underwent at (atrial tachycardia) ablation procedure that included thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced cardiac arrest that required cardiac massage, respiratory management by intubation.Timing: during use of biosense webster products , after dc.Description of health hazard: respiratory arrest, blood pressure decreased pericardial effusion was not observed by body surface echocardiography.Cardiac massage and respiratory management by intubation (with spontaneous breathing) was performed.Spo2, the blood pressure, the blood gas level returned to normal.Cf monitoring methods: real time graph; dashboard; vector; visitag.Visitag coloring settings: tag index.Physician's opinion on the relationship between the event and the product: blood pressure and respiration decreased after defibrillation to terminate arrhythmia.The event was not related to carto or the ablation.Medical history/treatment history/other diseases currently being treated, etc.: heart failure, pacemaker implantation (ddd setting).The complaint product(s) will be not returned for analysis.Additional event info received: the adverse events occurred on (b)(6) 2023.Additional event info received 14-jul-2023: physician's opinion on cause of adverse event: patient condition.The physician commented that the cause was medication for sedation during dc cardioversion.Patient improved but the patient is still in the hospital.The patient required extended hospitalization because of covid.Additional event info received 18-jul-2023: rf ablation was delivered before the event.It was reported that there were no problems occurred during the ablation.Generator information: smartablate generator, the serial number was unknown.Carto3 ver.V7.2.40.250.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.

Manufacturer Narrative

On 12-sep-2023, the product investigation was completed as the complaint device was not returned.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 31009602l number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• 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: 17398249
• MDR Text Key: 319863961
• Report Number: 2029046-2023-01597
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 10/06/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31009602L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 09/12/2023
• Supplement Dates FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/25/2023
• 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; CARTO VISITAG MODULE; LASSO NAV SPLITHANDLE; SMARTABLATE GENERATOR
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 50 KG