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

Model Number D134702

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 04/16/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf uni-directional navigation catheter.The patient suffered cardiac tamponade requiring a pericardiocentesis.It was reported that the physician performed an afib ablation + cavotricuspid isthmus ablation on a patient on friday (b)(6) (with stsf).The cti (cavotricuspid isthmus) was difficult to ablate with the stsf catheter so the physician decided to use also an abbott ablation catheter (designed for the cti ablation).It was reported that the patient had a delayed pericardial effusion on the procedure day.The physician believes that the ablation on the cti with the stsf is the cause of the intracardiac hematoma and the pericardial effusion as he thinks this catheter is too stiff and not designed for that.The catheter was reported as not defective.The device functioned as designed.This event is being reported for the adverse event and not the physician's/customer's device preferences.The pericardial effusion was discovered the (b)(6)2023 after the procedure that was performed on the (b)(6)2023.The adverse event was discovered post use of biosense webster products.Physician¿s opinion on the cause of this adverse event was bwi product without malfunction.Intervention provided was a pericardial drainage on the (b)(6)2023.Smartablate generator sn (b)(6) was used.Thermocool® smarttouch® sf catheter was used.Ablation index: coloring thresholds low: 350 high : 450 was the color options used prospectively.Transseptal puncture was performed with a brk needle, they don¿t know the exact model.Prior to noting the pe or ct, ablation was performed.No evidence of steam pop.The event occurred 2 days after the procedure.Irrigated catheter was used in the event, flow setting was the recommended flow settings: 15ml for 35w.Correct catheter settings were selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.No error messages observed on biosense webster equipment during the procedure.Force visualization features were used was dashboard, vector and visitag.Visitag module was used, parameters for stability used was respiratory adjustment ¿ minimum distance- 3mm, minimum time- 3s; force over time-25%, minimum force-3; the tag size was 3mm radius.No additional filter used with the visitag.Additional note: the reference to hematoma is understood as the effusion collecting in the pericardium sac and this is more commonly called cardiac tamponade and treated with pericardiocentesis.Given the location of the ablation, it would not be clinically reasonable to assume an aortic hematoma had occurred.Therefore, this event is being reported for a "cardiac tamponade" and will be coded in section h of this report as such.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious.

Manufacturer Narrative

E1 initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16933700
• MDR Text Key: 315240750
• Report Number: 2029046-2023-01028
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• 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: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134702
• Device Catalogue Number: D134702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/18/2023
• 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: ABBOTT ABLATION CATHETER; BRK NEEDLE; CARTO 3 SYSTEM; CARTO VISITAG MODULE; SMARTABLATE GENERATOR; UNSPECIFIED PUMP
• Patient Outcome(s): Required Intervention; Life Threatening