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 11/14/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: =(b)(6).An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device 30892332l number, and no internal action related to the complaint was found during the review.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 an 82-year-old, female patient underwent an unknown ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring a pericardiocentesis and prolonged hospitalization.It was reported that steam pop occurred while conducting ablation of cavotricuspid isthmus (cti).Pericardial drainage was performed, but there was a lot of bleeding.The physician judged that the wound would need to be sutured surgically.The patient was emergently transferred to shiga medical university hospital.Atrial septal puncture was performed by a radiofrequency (rf) needle.Ablation was performed before tamponade was identified.Steam pop was confirmed.Irrigation catheter¿s flow rate setting: pre-1 second, post-3 seconds.30 w <8 ml.31 w> 15 ml.The physician's opinion on the relationship between the event and the product was that the junior physician conducted ablation at the cti but took a long time for the ablation to complete because of difficulty.Because additional ablation was performed under the condition that the myocardium was hot, steam pop occurred.Outcome of the adverse event was improved.Pericardial drainage was conducted, but there was so much bleeding that it was judged necessary to surgically suture the wound, and the patient was urgently transferred to another hospital due to surgical treatment and extended hospitalization was required.There were no abnormalities observed prior to and during use of the product.The event occurred during the ablation phase.No error message observed during the ablation procedure.Force visualization features used were real time graph, dashboard, vector and visitag.Additional filter used with the visitag was fot.Color options used prospectively was tag index.The condition of the patient at the time of the call is unknown because the patient was transferred to another hospital.Surgical treatment for cardiac tamponade was performed at the other hospital.The generator used was a smartablate.The correct catheter setting was selected on the generator.The pump irrigation flow rate setting was normally controlled by the generator without any issues.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.Parameters for stability of visitag module: range2 time5; fot25%5g; tag size2.Since the event (cardiac tamponade) 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 and mdr-reportable.Steam pop is not considered to be a device malfunction.Steam pop is an expected physiological phenomenon.

• 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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15974381
• MDR Text Key: 305415097
• Report Number: 2029046-2022-03096
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2022

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 Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30892332L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• 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: PENTARAY NAV ECO 7FR, D, 2-6-2; SMARTABLATE GEN. KIT (JAPAN); UNK RADIOFREQUENCY (RF) NEEDLE; UNK_CARTO 3
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Female