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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 12/02/2022

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.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.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: (b)(4).

Event Description

It was reported that a patient underwent an idvt ¿ left ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring a pericardiocentesis.The patient suffered a pericardial effusion.Towards the end of the case, the physician was using intracardiac echocardiography (ice) to check his catheter position and noticed the effusion.A transthoracic echo was performed to confirm the pericardial effusion.A pericardiocentesis was performed and about 15 cc of fluid was removed from the pericardial space.Patient is stable currently and was stable throughout the entire procedure.No ablation was performed as there was no area to ablate.The physician thinks that the effusion happened from the transseptal using the agilis sheath.They are unsure if the catheter has been preserved for return and noted that the packaging has been discarded so the lot is unknown.Additional information was received.The adverse event was discovered during use of biosense webster products.Physician¿s opinion on the cause of this adverse event was transseptal procedure.Patient was stable while in the lab.Unknown if patient required extended hospitalization because of the adverse event.Relevant tests/laboratory data-echo.Other relevant history-unknown.Generator information-unknown.Transseptal puncture was performed with a baylis needle.No evidence of steam pop.The event occurred during the transseptal phase.No radio frequency was given.The device is not available for return.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16076207
• MDR Text Key: 306408075
• Report Number: 2029046-2022-03258
• Device Sequence Number: 1
• Product Code: LPB
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• 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: 12/02/2022
• 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
• Treatment: NON BWI ¿ AGILIS SHEATH.; NON BWI ¿ BAYLIS NEEDLE.; UNKNOWN BRAND GENERATOR.
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Female