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 Chest Pain (1776); Death (1802)

Event Date 02/05/2019

Event Type  Death  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no device history record (dhr) review could be performed.Concomitant products: lasso nav 2515,22p splithandle (model#d-1343-01-s, lot#unknown); carto3 external ref patch 6pack (model#d-1283-02, lot#ll018062); carto 3 system (model#m-4800-01, serial (b)(4)).Manufacture reference no: (b)(4).

Event Description

It was reported that a (b)(6) male patient with history of ischemic, hypertrophic and rhythmic cardiomyopathy, left ventricle ejection fraction (lvef) of 35%, vascular disease (aortic thrombosis) and broncho-pneumopathie chronic obstructive (bpco) pulmonary disease, underwent a pulmonary vein isolation (pvi) ablation procedure for persistent atrial fibrillation with a thermocool smart touch sf bidirectional catheter and suffered death.On (b)(6) 2019, the patient underwent a successful ablation procedure with no immediate patient consequences.No biosense webster inc.(bwi) product malfunctions were reported.Post-procedure, the patient developed chest pain.On post-procedure day 2, transthoracic echo (tee) was performed and was reported to give normal results, chest pain spontaneously stopped, and the patient was discharged.On post-procedure day 5, the patient suddenly died.Physician¿s opinion regarding cause of death was that it was independent of bwi product use.The physician does not make a link between the death and using bwi products.

• 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 ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8414961
• MDR Text Key: 138629337
• Report Number: 2029046-2019-02793
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030031
• 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: 02/14/2019

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: 02/14/2019
• Initial Date FDA Received: 03/12/2019
• 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): Death
• Patient Age: 66 YR
• Patient Weight: 70