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 10/30/2020

Event Type  Injury  

Manufacturer Narrative

Patient code of ¿no code available¿ represents ¿surgical intervention.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 was performed for the finished device (b)(4) im number, and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: pc (b)(4).

Event Description

It was reported that a male patient (71 year old) underwent cardiac ablation procedure for paroxysmal atrial fibrillation with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring surgical intervention.After mapping only in the right atrium, and before performing the transseptal procedure, the intracardiac echo catheter was inserted.It was then noticed that an effusion had developed.Heparin was stopped and reversed with protamine.A transthoracic echo confirmed effusion.The patient was transferred to the operating room where 250ml were drained via a pericardial window and drain was placed.While in the electrophysiology (ep) lab the patient was hemodynamically stable.The patient¿s condition required extended overnight stay and their condition was improved.The physician considers procedure as the cause of the event.The adverse event was discovered during use of biosense webster product.No ablation was performed.Standard irrigation flow of 2ml was used for mapping.There were no error messages observed on biosense webster equipment during the procedure.Graph, dashboard and vector were used for force visualization.

• 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: 10868841
• MDR Text Key: 217146812
• Report Number: 2029046-2020-01786
• 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: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30433271M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2020
• 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; UNKNOWN BRAND ICE CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 71 YR