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

Model Number D134804

Device Problems Display or Visual Feedback Problem (1184); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Tamponade (2226)

Event Date 03/26/2021

Event Type  Death  

Manufacturer Narrative

Date of death has been left blank as no information on the date of death has been provided.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2021-00628 for product code d138502 (carto vizigo¿ 8.5f bi-directional guiding sheath - medium) (2) this report for product code d134804 (thermocool® smart touch® sf bi-directional navigation catheter).

Event Description

It was reported that an (b)(6)-year-old female ((b)(6) lb) underwent an atrial flutter left (l-afl) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis and the patient was later reported to have died of a tension pneumothorax.During a left atrial flutter case, a pericardial effusion was noticed.The perforation was discovered when the vizigo sheath became disconnected electrically.The physician had just switched the ablation catheter with the pentaray catheter.The physician was not able to visualize the catheter and thought it was due to not having enough matrix so he kept advancing the catheter.The physician then discovered the sheath had been disconnected and upon reconnection, he was able to visualize the catheter and that it was way outside the appendage.The cardiac tamponade was confirmed by intracardiac echo (ice).Cardiac thoracic (ct) surgery was brought in and the medical intervention provided was a pericardiocentesis and 700cc of fluid was removed.The patient was reported to be in stable condition.The physician believed the vizigo sheath caused the pericardial effusion.At the time of the injury, the ablation catheter was being swapped out with the pentaray catheter.The adverse event occurred after ablating, but prior to re-mapping.Transseptal puncture was performed using a baylis nrg transseptal needle.There was no evidence of steam pop.An irrigated catheter was used and flow settings were set at normal stsf flow settings (2 ml/min while off ablation, 8ml/min less than 30w power, 15ml/min 30w or greater power), however, the thermocool stsf catheter was not in the body when the adverse event occurred.The correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation.No error messages were observed.The only indication that something was not normal was the loss of visualization of the vizigo sheath.Force visualization features used were: dashboard & vector.Visitag module was used with parameters set to surpoint settings (3mm, 3sec, 25%, 3g) and 3mm tag size was utilized.Visitag module was used with respiratory gating active and color option used was tag index.

Manufacturer Narrative

Additional information/clarification was received on 6/10/2021.It was reported that the physician was using vizigo for the first time.After completing a lateral mitral flutter line, the thermocool® smart touch® sf bi-directional navigation catheter was being changed for the pentaray catheter.At that time, the vizigo was disconnected from the carto system.The physician misinterpreted the loss of sheath image on the carto system as a lack of spatial geometry not allowing the visualization of the sheath and began to advance the sheath without fluoroscopy in the hopes of creating more geometry and eventual visualization of the sheath.When the sheath was reconnected, it was noted to be far outside the original geometry suggesting perforation.A pericardial effusion was noted and pericardiocentesis was performed.The patient had been intubated for the procedure and left the room intubated.The patient later passed away due to tension pneumothorax.No product malfunctions or defects were noted during the case.The loss of sheath visualization was due to inadvertent disconnection from the carto system and not related to lack of geometric point collection on the carto system.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number: (b)(4) has two reports: (1) mfr#: 2029046-2021-00628 for product code: d138502 (carto vizigo¿ 8.5f bi-directional guiding sheath - medium) (2) mfr#: 2029046-2021-00629 for product code: d134804 (thermocool® smart touch® sf bi-directional navigation catheter).

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11704884
• MDR Text Key: 246651668
• Report Number: 2029046-2021-00629
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8.5F SHEATH WITH CURVE VIZ MDC.; BAYLIS NRG TRANSSEPTAL NEEDLE.; UNK_CARTO 3.; UNK_PENTARAY.; 8.5F SHEATH WITH CURVE VIZ MDC.; BAYLIS NRG TRANSSEPTAL NEEDLE.; UNK_CARTO 3.; UNK_PENTARAY.
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 85