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

Catalog Number D134804

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

Patient Problems Air Embolism (1697); ST Segment Elevation (2059)

Event Date 11/07/2019

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.A manufacturing record evaluation was performed for the finished device 30273608m number, and no internal action related to the complaint was found during the review.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a (b)(6) male patient underwent an atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered st segment elevation and air embolism.At the beginning of the procedure, after the transseptal procedure, the physician noticed a drop in blood pressure of the patient.The physician checked for an effusion on intracardiac echocardiogram, but no effusion was present.A st-elevation myocardial infarction (stemi) was confirmed by checking the 12 lead electrocardiogram signals.The stemi seemed to resolve in about 10 minutes and the procedure was aborted.An echocardiogram was performed to look at the chamber function.Physician injected contrast through the arteries and confirmed that there was no longer any blockage.The patient was reported to be in stable condition.It is unknown if extended hospitalization was required.Physician¿s opinion on the cause of the event is that the thermocool® smart touch® sf bi-directional navigation catheter may not have been flushed before going into the body and some bubbles were introduced into the heart.During the event, biosense webster catheters were in the left atrium but no ablation had been performed yet.Per the thermocool® smart touch® sf bi-directional navigation catheter instructions for use (ifu) the catheter and tubing must be flushed per standard technique to ensure purging of trapped air bubbles and to verify that the irrigation holes are patent.

• 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: 9410660
• MDR Text Key: 170664642
• Report Number: 2029046-2019-03951
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2020
• Device Catalogue Number: D134804
• Device Lot Number: 30273608M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 58 YR