MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. UNK_SMART TOUCH BIDIRECTIONAL SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

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

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

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Concomitant medical products: carto 3 system (us catalog # unknown, serial # unknown).Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent a ventricular tachycardia (vt) ablation procedure with a thermocool smart touch sf catheter and suffered ventricular fibrillation and cardiac arrest requiring cardiopulmonary resuscitation (cpr), medication and extracorporeal membrane oxygenation (ecmo).During the procedure, after performed vt bipolar map, the physician tried to induce vt to map it; however, the patient went in ventricular fibrillation.Reminder of the procedure was aborted.Cpr was performed to get sinus rhythm, after that, patient¿s blood pressure dropped, and the patient was in asystole.Several unspecified drugs were administered, and cpr maneuvers were applied.Patient was finally put into ecmo and is waiting for transplantation.Extended hospitalization was required.Patient¿s outcome is unchanged.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition related.Ablation was not performed during the procedure.No further information is available.

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL SF
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8352734
• MDR Text Key: 136595792
• Report Number: 2029046-2019-02705
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2019

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: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention