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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Arrest (1762)

Event Date 03/06/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an afib ¿ paroxysmal ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a cardiac arrest.It was reported that during a paf ( paroxysmal afib) procedure , there was administration of isp (isoproterenol) and atp ( adenosine triphosphate) at induction after pvi (pulmonary vein isolation) and ct ( computed tomography)at the first administration of atp, af ( atrial fibrillation) occurred and stopped spontaneously.Transition from af onset to vt ( ventricular tachycardia) and then vf ( ventricular fibrillation ) at the second administration of atp.Cardioversion was performed 5 times but did not return to sr ( sinus rhythm).Proceeded to cpr including cardiac massage and extracorporeal membrane oxygenation (ecmo) placement.Timing when complaints occurred was after completion of all treatments at about 200 minutes after entering the room and after administration of the second isp and atp as the last induction.Circulatory failure due to vt and vf.Ecmo (extracorporeal membrane oxygenation ) and iabp (intra-aortic balloon pump ) insertion were performed.The physician's opinions on the relationship between the event and the product was that there was no relationship with the product.There were no abnormalities observed prior to and during use of the product.[relevant medical history]: medical history: omi, vt present.Pci and cabg were implanted for omi; icd was implanted for vt." the soundstar catheter is not from sterilmed.This adverse event discovered post use of biosense webster products.Patient did require extended hospitalization because of the adverse event.No products will be returned.Additional information- -the catheter is not from sterilmed.They tried to obtain lot number information, but we were unable to obtain the information because no record was kept.Additional information- this adverse event was discovered during use of biosense webster products.Physician¿s opinion on the cause of this adverse event was not related with the bw product; due to procedure; induction by administration of isp(isoproterenol).The patient has not been recovered yet.The patient was disengaged from ecmo and regained consciousness, but left hemiparesis was present.Hospitalization was extended due to observation for residual sequelae.Relevant tests/laboratory data --- nothing in particular.Smartablate generator was used, the serial number was unknown.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 and mdr-reportable.

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.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).

Manufacturer Narrative

On 25-may-2023, the product investigation was updated to include the manufacturing record evaluation.A manufacturing record evaluation was performed for the finished device number lot 30949217l and no internal action related to the complaint was found during the review.The manufacture date (1-dec-2022) and expiration date (30-nov-2025) were updated accordingly."analysis of production records" code was added to the h6 type of investigation.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: 16659685
• MDR Text Key: 312494571
• Report Number: 2029046-2023-00699
• 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: 06/21/2023

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 Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30949217L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2022
• 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; PENTARAY NAV; SMARTABLATE GENERATOR; SOUNDSTAR ECO; UNSPECIFIED PUMP
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Male