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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Tachycardia (2095); Perforation of Vessels (2135)

Event Date 10/18/2022

Event Type  Injury  

Event Description

It was reported that a 67-year-old male patient (born on (b)(6) 1955) underwent an non-ischemic ventricular tachycardia (non-isvt ¿ left) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and suffered perforation requiring cpr, blood transfusion, surgical intervention and prolonged hospitalization.During a premature ventricular contractions (pvcs) ablation, they mapped the right side first with a pentaray, med agilis, and stsf.They got groin access for retro grade aorta.Access proved difficult as it was torturous to get up.Ablation catheter would not advance so they swapped for pentaray.Pentaray advanced into the aorta and they mapped.Swapped for stsf, which would not advance.They switched groin site to left.Wire would not advance, and ablation catheter would not advance.Patient went into tachycardia, pressure dropped to 70 and code was called.Compressions started at 30, and fluid was given.Pressure came back up to 66, contrast given into aorta.Vascular surgery started, 11 units blood given., patient stable, no ablation performed.Mapping only.The surgery was not delayed due to the reported event.There were patient consequences.The patient underwent cardiac vascular surgery post op.Other medical interventions were required: code called, compression done, blood and plasma given.The patient is not part of a clinical study.Software version 7.1.80.33.No service is needed for equipment.The patient is currently stable and recovering in icu.The physician¿s opinion on the cause of this adverse event is that it was the procedure and patient condition related.The patient outcome of the adverse event is improved and on the way to a full recovery.The patient required extended hospitalization because of the adverse event as the patient needed to be observed and have additional recovery times.A stockert gmbh smart ablate system rf generator with serial number (b)(4) was used.Additional information was received on (b)(6) 2022: the site of perforation was the left femoral artery.Surgeons¿ opinion was that the patient had advanced vascular disease that caused plaque in the arteries, and this was the major cause of the adverse event.

Manufacturer Narrative

Initial reporter name and address: initial reporter phone: (b)(6).An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device number 30857246l and no internal actions 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.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER (STSF)
• 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: 15808179
• MDR Text Key: 303792702
• Report Number: 2029046-2022-02837
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30857246L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2022
• 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 (FOR JAPAN); PENTARAY NAV ECO 7FR, D, 2-6-2; SMARTABLATE GENERATOR KIT-WW; UNK MED AGILIS
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 67 YR
• Patient Sex: Male