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

Model Number D134805

Device Problems Erratic or Intermittent Display (1182); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Tachycardia (2095); Cardiac Perforation (2513)

Event Date 11/21/2022

Event Type  Death  

Event Description

It was reported that a 62 year old female patient underwent an idvt ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring a pericardiocentesis and then passed away.It was reported that during a pvc procedure, a pericardial perforation and effusion was diagnosed after the patient's pressure dropped and they were in tachycardia.The ablation catheter was visualized jumping at the time the rate changed and the pressure dropped.A pericardiocentesis was performed unsuccessfully, by the physician.The patient was too unstable to move to the cardiothoracic operating room, so the surgery team was brought in to repair the perforation.An lv dissection was found, and the surgery was still going on at the time of the call.Bwi representative called back stating that the patient passed away around 5pm on (b)(6) 2022.The patient was reported to be in vf when taken off of ecmo.They also stated that the surgery could not fully patch the lv peroration.Catheter lot number unavailable due to the catheter and box being discarded before code situation occurred and information obtained.The event occurred on (b)(6) 2022.The adverse event was discovered during use of biosense webster products.Physician¿s opinion on the cause of this adverse event was the procedure.Interventions provided was pericardiocentesis, open heart surgical repair and aortic valve replacement.Outcome of the adverse event was death; the patient did not survive the adverse event.Patient age at the time of event or date of birth 62; 5/8/1960.Relevant tests/laboratory data unremarkable pre procedure.Other relevant history- history of mi; unknown when and what kind of mi.Generator information- stockert smart ablate serial number: (b)(4).In physician¿s opinion, the cause of death was complications from cardiac tamponade and blood loss post cardiac perforation and lv tear.After ablation below the left and right coronary cusp junction, the catheter was visualized ¿jumping¿/moving to an area above the ablation site.Within a few seconds, the catheter was repositioned to the area of ablation and the vital signs started to indicate a perforation had occurred.Immediately following the change in vitals and upon evaluation with the soundstar ultrasound catheter, it was determined the patient had indeed developed a significant effusion in the lv and the patient was immediately prepped for a pericardiocentesis and code was called.Simultaneously, the cardiothoracic team was called in to open the patients chest and fix whatever had occurred.They discovered an lv perforation with a tear and performed surgery to fix the patients issue.An aortic valve replacement was eventually performed but, ultimately, after about 4 hours of open heart surgery, the patient did not survive the procure.No transseptal puncture performed.Ablation performed was performed prior to noting the pe or ct, one lesion was applied to the area below the left and right coronary cusp.No evidence of steam pop.The event occurred post ablation phase.The flow setting for the irrigated catheter was 15ml/min.Correct catheter settings was selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.Wattage did not change so pump started at 2ml/min pre ablation, switched to 15ml/min during ablation and returned to 2ml/min post ablation.No error messages observed on biosense webster equipment during the procedure.Force visualization features used was graph , dashboard and vector.Icon jumping is not mdr-reportable.All deaths where bwi fda approved ¿ ce mark devices are involved are reportable.

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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).

Manufacturer Narrative

On 2-jan-2023, bwi received additional information regarding the event.There was never an issue with the catheter or catheter visualization.Upon using the timeline feature with carto with the physician, the "catheter jumping" was when they determined the perforation must have occurred.No malfunction occurred and was never implied by the physician.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(6) per internal review on 29-dec-2022, clarification was completed on the statement : "after ablation below the left and right coronary cusp junction." this was determined to mean that the catheter was visualized ¿jumping¿/moving to an area above the ablation site.".

• 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: 16007660
• MDR Text Key: 305739598
• Report Number: 2029046-2022-03172
• Device Sequence Number: 1
• Product Code: LPB
• 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: 01/19/2023

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
• 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
• Supplement Dates Manufacturer Received: 12/29/2022
• Supplement Dates FDA Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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.; SMARTABLATE GENERATOR.; UNSPECIFIED PUMP.
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female