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

Catalog Number D134805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 05/14/2019

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturing record evaluation cannot be conducted because no lot number was provided by the customer.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a (b)(6) male patient underwent an ablation procedure for paroxysmal atrial fibrillation with a thermocool smart touch sf bi-directional navigation catheter and suffered ventricular tachycardia (vt), ventricular fibrillation (vfib) and cardiac arrest requiring immediate resuscitation efforts (shock, chest compression's, code blue and extracorporeal membrane oxygenation (ecmo)) during the ablation phase the patient went into vt, this was confirmed by electrocardiogram.The rf was stopped, and the patient was shocked twice.The patient went into vfib which results in cardiac arrest.The code team was called and started chest compression's.The patient was placed on an ecmo machine and was transferred to the intensive care unit (icu).Patient¿s condition improved.Extended hospitalization was required as a result of the adverse event.Physician¿s opinion regarding the cause of the adverse event is that it was procedure and patient condition related.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8669971
• MDR Text Key: 147036558
• Report Number: 2029046-2019-03225
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/14/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2019
• Initial Date FDA Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 55 YR