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 11/21/2022

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30892433l 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a 82-year-old male patient underwent an unknown ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring a pericardiocentesis.Situation- there were no product malfunctions.Timing when complaints occurred was when cardiac tamponade was confirmed after removal of the catheter.Accumulation of pericardial effusion was confirmed after removal of the catheter.Drainage was performed, and the patient is followed up.The patient¿s condition is stable.The physician's opinions on the relationship between the event and the product was that the event was not caused with the product malfunctions.There were no abnormalities observed prior to and during use of the product.The complaint product(s) will not be returned for analysis.Procedure : premature ventricular contraction physician¿s opinion on the cause of this adverse event was that it was not related to the bw product malfunction.Outcome of the adverse event was fully recovered.It was unknown when the patient was discharged from the hospital.The patient required extended hospitalization due to follow-up after cardiac tamponade.Relevant tests/laboratory data---nothing special.Other relevant history---nothing special.Generator information-smart ablate generator (m4900207, s/n:(b)(4)).Transseptal puncture was performed with rf needle.Ablation was performed prior to noting the pe or ct.There was no evidence of steam pop.Flow setting for the irrigated catheter was used in the event was pre rf time: 2sec, post rf time: 5sec, during ablation up to 30w: 8ml/min, over 31w: 15ml/min.Correct catheter settings was selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.No error message observed during the procedure.Force visualization features used were real time graph; dashboard; vector; visitag.Parameters for stability for the visitag module used (range; time; fot; tag size)---range 3mm, time 3sec, fot 25%, tag size 4mm.Fot was used as additional filter.Color options used prospectively was tag index.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.

• 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: 16006597
• MDR Text Key: 305732686
• Report Number: 2029046-2022-03170
• 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
• Report Date: 12/19/2022

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: 30892433L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/19/2022
• 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: CARTO 3 SYSTEM; CARTO VISITAG MODULE,; PENTARAY CATHETER; RF NEEDLE (TRANSSEPTAL); SMARTABLATE GENERATOR; SOUNDSTAR CATHETER
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 82 YR
• Patient Sex: Male