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

Catalog Number D134805

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

Patient Problems Cardiac Arrest (1762); Cardiac Tamponade (2226)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.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.A manufacturing record evaluation was performed for the finished device 30269866m number, and no internal actions related to the complaint was found during the review.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a male patient underwent a paroxysmal atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac arrest and cardiac tamponade requiring pericardiocentesis.At the end of the procedure, a cardiac tamponade was noticed as the patient's blood pressure dropped.The cardiac tamponade was confirmed by a transthoracic echocardiogram.Cardiopulmonary resuscitation, pericardiocentesis was performed in which over 3000cc of fluid was removed and fresh frozen plasma was given.The patient was reported to be in stable condition post intervention.It is unknown if extended hospitalization was required.Physician¿s opinion on the cause of the event was that it was procedure related.A cardiac tamponade was performed with a baylis device.Ablation was performed prior to discovering the cardiac tamponade.There was no evidence of a steam pop during the procedure.Flow setting was 8 ml/min or 15 ml/min.There were no error messages observed on biosense webster equipment during the procedure.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION
• 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: 9393367
• MDR Text Key: 168657391
• Report Number: 2029046-2019-03942
• 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: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 08/08/2020
• Device Catalogue Number: D134805
• Device Lot Number: 30269866M
• Date Manufacturer Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2019
• 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: BAYLIS TRANSEPTLE NEEDLE
• Patient Outcome(s): Life Threatening; Required Intervention