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 11/17/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter facility name (cont.): (b)(6).Initial reporter phone: (b)(6).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 male patient underwent an unknown ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tampondade.It was reported that after the procedure, tamponade was confirmed by echo.Atrial septal puncture was not performed.Ablation of 12 places were performed at right ventricular outflow tract (rvot) before tamponade was identified.Steam pop was not confirmed.Irrigation catheter¿s flow rate setting: pre0 and post 3 ml settings.Other settings were default.The physician's opinion on the relationship between the event and the product was that there was no relationship with the carto 3 system.There were no abnormalities observed prior to and during use of the product.Relevant test/lab data- drainage volume 275 ml.No further information is available.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

Additional event information was received on 16-jan-2023.It was reported that the adverse event was discovered post use.Cardiac drainage was conducted as an intervention.Force visualization features were real time graph; dashboard; vector; visitag.Tag index color options were used.A smartablate generator was used (serial number is unknown).Based on the additional information received, the concomitant product section was updated and unk_smartablate generator was added.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

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Section h3.Has been updated.A manufacturing record evaluation (mre) was performed for the finished device and no internal action related to the complaint was found during the review.Additionally, the manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.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: 15992246
• MDR Text Key: 305582741
• Report Number: 2029046-2022-03137
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• 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
• Device Lot Number: 30897654L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2022
• 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: 8.5F SHEATH WITH CURVE VIZ SMC; UNK_CARTO 3; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Life Threatening
• Patient Sex: Male