BIOSENSE WEBSTER INC CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM; INTRODUCER, CATHETER
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Model Number D138502 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Cardiac Tamponade (2226)
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Event Date 03/26/2021 |
Event Type
Death
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Manufacturer Narrative
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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.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) mfr # 2029046-2021-00629 for product code d134804 (thermocool® smart touch® sf bi-directional navigation catheter).
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Event Description
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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.
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Manufacturer Narrative
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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.The device evaluation was completed on (b)(6) 2021.It was reported that an 83-year-old female (187 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.Device evaluation: visual analysis of the returned sheath revealed that no damage or anomalies were observed on carto vizigo sheath.The sheath was connected to the carto 3 system, and it was recognized and visualized; no electrical issue found during ecg test.The sheath was deflecting, and water was flushed into the sheath from the distal end using a syringe on the 3-way stopcock to verify if the hemostatic valve is disrupted for air to enter into the sheath.Additionally, the test method for liquid leakage through hemostatic valves of sheath introducers was performed, and no water leakage, bubbles or pressure decays were detected during the test.The device history record (dhr) for the lot number 00001567 has been received and internal action related to the complaint was found during the review.No malfunction was observed during the sheath analysis.The instructions for use contain the following recommendations: -use fluoroscopy and/or intracardiac ultrasound to monitor the advancement of the catheter and removal of the catheter from the sheath.Move the catheter carefully to avoid cardiac damage, perforation, or tamponade.If resistance is encountered, do not use excessive force to advance or withdraw the catheter through the sheath.The root cause of the adverse event remains unknown.The event described could not be confirmed as the as the sheath performed without any issue.Although no sheath defect was identified, there may have been other circumstances or issues that occurred during the use of the sheath that could not be replicated during the laboratory analysis.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).
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