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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 10/18/2022

Event Type  Injury  

Event Description

It was reported that a 65-year-old male patient weighing 160 lbs.Underwent an afib ¿ persistent ablation procedure with a thermocool® smart touch® s f bi-directional navigation catheter.The patient suffered cardiac tamponade requiring a pericardiocentesis.It was reported that during the procedure, the physician wanted to re-seat the smarttouch sf catheter cable.The cable was re-seated, and afterwards, the temperature reading on the smartablate generator was lost, for the smarttouch sf catheter.The cable was replaced without resolution.The smarttouch sf catheter was replaced, and the issue resolved.The procedure continued.It was also reported that during a persistent atrial fibrillation case, a cardiac perforation to the coronary sinus was noticed in the patient.When initially mapping with the smarttouch sf catheter, they had noticed that the smarttouch sf catheter appeared to be moving more freely than normal, around the coronary sinus.While monitoring on ice (intracardiac echocardiography), before going transseptal, it was noticed there was a developing pericardial effusion present in the patient, which had progressed to fill the chamber.The medical intervention provided was a pericardiocentesis, and at least 500 ml of fluid was removed, the exact amount of fluid is unknown.The pericardial effusion then developed into a cardiac tamponade.Cardiac surgery was then performed to repair the cardiac perforation to the coronary sinus.Open-heart surgery was performed, and the cardiac perforation was sutured.Patient is stable condition.It was reported that in the commotion of the complication they were not able to get the lot number for the catheter that was used for the perforation.The lot number from this complaint is from the other products that had temperature error.The adverse event was discovered during use of biosense webster products.Physician¿s opinion on the cause of this adverse event was due to patient condition - patient had a very challenging cs to enter which led to the complication.The outcome of the adverse event was improved - the patient recovered and survived the perforation, however they could not say fully recovered since they did require open heart surgery to resolve the issue.Additional hospitalization was required after the cardiac surgery.Usually patients only stay 1 extra night after af ablation with this ep.Patient details at time of event was a 65 year old male patient weighing 160lbs.Generator information was a stockert smartablate generator with serial number (b)(4).Transeptal was performed but this was not the cause of the tamponade.Needle was abbot - sl1.Brk used.Covidien bovi used for rf energy for transeptal.No ablation was performed.No evidence of steam pop.Standard flow setting for the stsf.Correct catheter settings were selected on the generator.Pump switching would have been from ¿low¿ to ¿high¿ flow during ablation, but they performed no ablation.No errors regarding this product for the perforation.Catheter force sensor was not activated again after the replacement was inserted.Ep was working to get into the cs and usually zeros product after transeptal.No visitag used.There was no additional filter used with the visitag.No color options were 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 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).

Manufacturer Narrative

On 7-nov-2022, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 14-dec-2022, the product investigation was completed.It was reported that a 65-year-old male patient weighing 160 lbs.Underwent an afib ¿ persistent ablation procedure with a thermocool® smart touch® s f bi-directional navigation catheter.The patient suffered cardiac tamponade requiring a pericardiocentesis.Device evaluation details: visual analysis revealed no damage or anomalies on the device.Per the event, several tests were performed.The magnetic, electrical, and force features were tested, and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.The temperature and impedance test was performed, and no temperature was displayed due to an open circuit on the tip area.A manufacturing record evaluation was performed for the finished device number, 30887205l, and no internal actions related to the complaint were found during the review.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.The root cause of the adverse event remains unknown.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® S F 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: 15741960
• MDR Text Key: 303148483
• Report Number: 2029046-2022-02760
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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,Followup
• Report Date: 01/02/2023

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: 30887205L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/07/2022
• Supplement Dates Manufacturer Received: 11/07/2022; 12/14/2022
• Supplement Dates FDA Received: 11/28/2022; 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2022
• 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.; SL1. BRK TRANSSEPTAL NEEDLE.; SMARTABLATE GENERATOR.; THERMOCOOL SF SMARTTOUCH.; UNSPECIFIED PUMP.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 73 KG