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 11/16/2022

Event Type  Injury  

Manufacturer Narrative

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 78 year old male patient weighing 53kg with a height of 155 cm underwent an unknown ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade (ct) requiring a pericardiocentesis and prolonged hospitalization.During conducting mapping of tachycardia, after insertion of smart touch sf catheter to the coronary sinus ostium (cs os), decrease in heartbeat was observed on ¿x-p¿.Presence of pericardial effusion (pe) was confirmed by echo.Drainage was performed.After that, the condition became stable, and the procedure was completed.The patient moved to the intensive care unit (icu).Atrial septal puncture was not performed.Ablation was not performed before pericardial effusion was identified.There were no abnormalities observed prior to and during use of the product.Relevant medical history]: aortic dissection and chronic rheumatoid arthritis.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 physician commented that cardiac tamponade might have occurred at that timing because contact force (cf) increased when the catheter was inserted into the cs.Pericardial drainage was conducted.Extended hospitalization was required because of follow-up observation at icu.The patient fully recovered (no residual effects).After returning to the icu, there was almost no drainage fluid aspiration, and the patient was followed up for one day in the icu.After that, the patient was moved to a hospital ward.Since the patient¿s condition was recovered, the patient was discharged from the hospital on (b)(6) 2022.A smartablate generator was used (serial number was unknown).No transseptal puncture was performed.Ablation was not performed prior to noting the pe or ct.There was no evidence of a steam pop.The event occurred during the mapping phase.No error message observed during the 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.

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: 15993344
• MDR Text Key: 305583591
• Report Number: 2029046-2022-03143
• 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,Followup
• Report Date: 12/15/2022

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: 30869308L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2022
• 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.; UNK_CARTO 3.; UNK_SMARTABLATE GENERATOR.
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 53 KG