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 11/29/2022

Event Type  Injury  

Event Description

It was reported that an 80-year-old female patient weighing 50.0 kgs.And a height of 158.00 cms.Underwent an atrial fibrillation (afib) ablation procedure with a soundstar eco 8fg ultrasound catheter and thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring a pericardiocentesis.Situation- after performing bb, blood pressure decreased when the cryo sheath was inserted into the la.Pericardial fluid was confirmed by echocardiography.Timing when complaints occurred was after performing bb.Pericardial drainage was performed.The patient¿s blood pressure was improved.Version information: v 7.2.40.250.Event: cardiac tamponade.The complaint product(s) will not be returned for analysis.The lot number of the soundstar catheter was confirmed as e8407474.Drainage was provided.The outcome of the adverse event was improved.Transseptal puncture was performed.No pop was reported.No error was reported.Force visualization features used were real time graph; dashboard; vector; visitag.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 and mdr-reportable.

Manufacturer Narrative

Initial reporter phone: (b)(6).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number 30886539l, 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was received on 23-dec-2022.It was reported that the adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was that it was procedure related.The patient did not require extended hospitalization because of the adverse event.Relevant tests/laboratory data was none.Other relevant history was none.Generator information was a smartablate m4900207, g4c-3546.Therefore, the concomitant product section was updated.The event occurred during the transseptal phase.Low flow setting was used for the irrigated catheter that was used in the event.Correct catheter settings were selected on the generator.The flow was controlled by generator normally.No error was reported.No parameters for stability were used for the visitag.No color options were used.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 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: 16017987
• MDR Text Key: 305873040
• Report Number: 2029046-2022-03201
• Device Sequence Number: 1
• Product Code: LPB
• 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,Followup
• Report Date: 01/20/2023

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: 30886539L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 12/23/2022
• Supplement Dates FDA Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: No
• 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: CARTO 3 SYSTEM.; CARTO VISITAG MODULE.; PENTARAY CATHETER.; SMARTABLATE GEN. KIT (JAPAN).; SOUNDSTAR ECO CATHETER.; UNSPECIFIED CRYO SHEATH.; UNSPECIFIED TRANSSEPTAL NEEDLE.
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 50 KG