MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134701

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 10/04/2022

Event Type  Injury  

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® uni-directional navigation catheter.The patient suffered cardiac perforation and cardiac tamponade requiring a pericardiocentesis.It was reported that during the ablation portion of an afib case, the patient suffered a perforation in the posterior wall of the roof of the left atrium and a pericardial effusion.The bwi representative reported that the patient¿s blood pressure dropped.The pericardial effusion was confirmed by ice.They called in an echocardiogram after the injury was confirmed by ice but was unable to confirm what was discovered with the echocardiogram.The medical intervention provided was a pericardiocentesis and it was unknown how much fluid was removed.No surgical intervention for the patient was needed at that time.The patient was reported to be in stable condition and that the patient was being monitored.The injury occurred towards the end of the procedure and the procedure was able to be completed.The adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event is the procedure.Outcome of the adverse event is improved.Patient was kept in the hospital for observation.Patient¿s details at the time of the event were a 77-year-old male weighing 79.5kg.Generator make and model is a g4c-6073-a.Needle details used for the transseptal puncture performed was an abbott brk-1.Ablation was performed prior to noting the pe or ct.There was no evidence of steam pop.Event occurred during the ablation phase.The flow setting for the irrigated catheter used in the event was standby flow, 2ml/min (suspected to not have happened during an active ablation application).Correct catheter settings were selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.The force visualization features used were graph, dashboard, vector and visitag.Recommended subpoint settings was the parameters used on the visitag module.There was no additional filter used with the visitag.Ablation index was the color options used.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

This report is being submitted pursuant to the provisions of 21 cfr, part 4.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

On 1-dec-2022, the product investigation was completed as the complaint device was not returned.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 lot 30823010l and no internal action related to the complaint was found during the review.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® UNI-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: 15688968
• MDR Text Key: 302570290
• Report Number: 2029046-2022-02682
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

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: D134701
• Device Catalogue Number: D134701
• Device Lot Number: 30823010L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2022
• Initial Date FDA Received: 10/28/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/20/2022
• 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: ABBOTT BRK-1 TRANSSEPTAL NEEDLE.; CARTO 3 SYSTEM.; CARTO VISITAG MODULE.; SMARTABLATE GENERATOR.; SMARTABLATE PUMP.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 79 KG