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

Model Number D134805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 11/01/2022

Event Type  Death  

Event Description

It was reported that a (b)(6) male patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool smart touch sf bi-directional navigation catheter.The patient suffered cardiac arrest which ultimately resulted in death.It was reported that the patient expired during the ablation procedure.The accuresp graph became flattened, and they alerted the physician.The physician then stopped ablating, observed the lateral border of the heart under fluoro imaging, and noted no movement.The patient's oxygen saturation (o2 sat) and blood pressure (bp) dropped, and cpr was started.The patient was resuscitated.No evidence of pericardial effusion had been seen on intracardiac echocardiography (ice) imaging via the soundstar catheter at any point during the procedure.The patient's bp and o2 sat dropped again.The medical team mentioned respiratory failure, and cpr was reinitiated.The patient's blood pressure was restored to over 150/60 with an o2 sat of "almost 98%".At this point, all catheters had been removed from the body.A stat echocardiogram was ordered.The patient's bp and o2 sat dropped for the third time and cpr was reinitiated.The patient eventually expired while in the procedure room.This adverse event was discovered during use of bwi products.The physician¿s opinion on the cause of this adverse event that there was no perforation, and the physician believed it to be patient-related/heart failure, not believed to be product-related.The patient outcome of the adverse event is death.A transseptal puncture was not performed, retrograde access used.There was no evidence of steam pop.The event occurred during ablation phase.An irrigated catheter was used in the event, the flow setting was 8/15 ml min.Error messages observed on biosense webster equipment during the procedure were: 401 error: map points cannot be acquired, 414: patch 4: magnetic distortion, and 444: patch 5: magnetic distortion.They were displayed on the carto 3 system early in the procedure and self-resolved before any mapping was performed.Unconfirmed v7 software, 7.2.40.250.All deaths were bwi fda approved.Ce mark devices are involved are 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Manufacturer Narrative

The device evaluation was completed on 21-dec-2022.It was reported that a 77-year-old male patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac arrest which ultimately resulted in death.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.Visual analysis revealed that no damage or anomalies on the device.Per the event, several tests were performed.The magnetic, electrical, temperature 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.During product analysis, the lot number was verified to be 30863650l.This was verified by electronically erasable programmable read only memory (eeprom) file.Therefore, the d4.Lot, d4.Expiration date, and h4.Device manufacture date have been updated.A manufacturing record evaluation was performed for the finished device 30863650l number, and no internal actions related to the reported complaint condition were identified.No malfunction was observed during the product analysis.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.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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

The biosense webster, inc.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).

• 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: 15884574
• MDR Text Key: 304501292
• Report Number: 2029046-2022-03000
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2022

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: 30863650L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 12/02/2022; 12/21/2022
• Supplement Dates FDA Received: 12/20/2022; 12/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2022
• 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.; SOUNDSTAR CATHETER.
• Patient Outcome(s): Required Intervention; Death; Life Threatening
• Patient Age: 77 YR
• Patient Sex: Male