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

Model Number D134805

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

Patient Problems Cardiac Tamponade (2226); No Code Available (3191)

Event Date 09/09/2020

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.(b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a female patient underwent cardiac ablation procedure for atrial fibrillation (afib)/flutter with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring surgical intervention.It was reported that during an afib/ cavotricuspid ishmus (cti) flutter case, a pericardial effusion was noticed as the patient's blood pressure dropped.This happened after a steam pop was heard.The pericardial effusion was confirmed by intracardiac echocardiography (ice).The caller reported that the medical intervention provided was a pericardiocentesis and it is unknown how much fluid was removed.The condition of the patient is currently unknown and is being evaluated.The patient was moved out of the ep lab and into the surgical section.The smartablate¿ generator was set to 40 watts of power and during the last ablation, the force values were between 20-30 grams.The temperature average for this ablation pass was 23°c and most other passes were averaging 22°c.This event was noticed during use of biosense webster products during ablation phase.The opinion of the physician is that the cause of this event was procedure.The event required surgical intervention to suture the perforation.The patient had fully recovered after extended hospitalization for recovery from surgical intervention.Transseptal puncture was performed with an unknown device.Prior to noting the effusion ablation was performed.The irrigation settings were 15ml/min.There were no error messages observed on biosense webster equipment during the procedure.Graph, dashboard, vector and visitag were used for force visualization.The visitag stability settings were 3 mm for 3sec, without additional filters.Impedance drop was used for color.

• 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 CA 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: 10653361
• MDR Text Key: 210653570
• Report Number: 2029046-2020-01455
• 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: Physician
• Type of Report: Initial
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2020
• 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): Hospitalization; Life Threatening; Required Intervention