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

Catalog Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Tachycardia (2095); Ischemic Heart Disease (2493)

Event Date 08/24/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a cardiac arrest, electrocardiogram st segment elevation and ventricular tachycardia.In pulmonary vein isolation (pvi) procedure, box isolation was performed (the ablation was conducted with 40-45w, cf10-20g, ai420).Pentaray nav eco catheter was removed from left atrium.After atrial tachycardia (at) mapping in right atrium (ra), shifted to af, and the blood pressure decreased.It was confirmed with using soundstar eco catheter that there was no effusion.Systolic blood pressure decreased to 30-40 mmhg, elevated pressure and cardiac massage were performed.Pcps (percutaneous cardiopulmonary support) was on standby.Transitioned from ventricular tachycardia (vt) to ventricular fibrillation (vf) and dc (direct current cardioversion) was performed.Temporarily returned from vt to sinus.Hypertensive medication was continued.A body surface ecg displayed st-segment elevation of the inferior wall guidance.Coronary angiography (cag) was performed and there was no significant stenosis.Then, rate, blood pressure were stable.Intubation was managed, iabp and external pacemaker were inserted, and the patient left the room and was moved to the intensive care unit (icu).Timing was after ra mapping.About 2.5 hours have passed since the start of the procedure.Patient information and progress will be collected in the next procedure or later.Method of cf monitoring was real time graph; dashboard; vector; and visitag.Coloring settings for visitag was tag index.Visitag additional filters was fot.Causal relationship with product was unknown.There were no abnormalities observed prior to and during use of the product.Patient medical history and concomitant diseases: previous history of hcm.Additional information was received on 28-aug-2023.The adverse event was discovered during use of biosense webster products.Outcome of the adverse event was improved.Prior to noting adverse event, ablation was performed.No evidence of steam pop occurred.The event occurred during the ablation phase.No error message observed.Additional information was received on 04-sep-2023.Outcome of the adverse event was fully recovered.Iabp and intubation management weaned the day after the procedure.The patient had been discharged from the hospital as of (b)(6) 2023 (the exact discharge date is unknown).The patient required extended hospitalization for additional treatment.Transseptal puncture was performed with rf needle (japan lifeline).Irrigated catheter was used in the event, the flow setting was pre rf time: 1 second, post rf time: 1 second.Correct catheter settings were selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).Secondary physician information provided: dr.(b)(6).Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 31080140l 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.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).

• 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: 17762564
• MDR Text Key: 323583002
• Report Number: 2029046-2023-02103
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134801
• Device Lot Number: 31080140L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2023
• 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: JAPAN LIFELINE RF NEEDLE; PENTARAY NAV ECO 7FR, D, 2-6-2; SMARTABLATE GEN. KIT (JAPAN); SOUNDSTAR ECO GE 8F CATHETER; UNK PUMP; UNK_CARTO 3
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Male