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

Model Number D134805

Device Problems High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 10/31/2022

Event Type  Injury  

Manufacturer Narrative

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.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).

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring a pericardiocentesis.It was reported that the carto 3 system displayed a catheter sensor error (number unknown) when the pentaray catheter was plugged into the piu.They reseeded the cable and exchanged the cable and the issue persisted.They exchanged the pentaray catheter, and the issue was resolved.The case continued.It was also reported that at the end of the case, while extracting the catheters from the patient, the patient blood pressure dropped, it was lower than it was when they started.The patient was treated.The soundstar catheter confirmed the patient had a pericardial effusion.The patient was stable.A pericardiocentesis was done and 95 ml of fluid was removed from the patient.The patient did not require any surgical repair.The drain was removed from the patient and the patient is stable.The physician thinks the effusion may have occurred during ablating of the cti line just above the ivc portion.There was an impedance spike noticed and the nurse came off of the rf energy.It was a right-sided effusion.They used a total of 40 watts on the left side for the atrial fibrillation and 35- 40 watts for the cti line.They used a vizigo sheath, soundstar catheter, pentaray catheter, and stsf ablation catheter.Brk needle utilized for transseptal puncture.Correct catheter settings selected on the generator.Flow settings were 17ml/min for the st sf above 30w for irrigation.Pump switching from ¿low¿ to ¿high¿ flow during ablation.Force visualization features were graph, dashboard, vector, and visitag.Visitag parameters for stability were 2,3,25%,3 and 3mm tag size.Respiration gating was also used with an accurate respiration graph.Tag index color options were used.The physician¿s opinion on the cause of this adverse event was the procedure.It is believed to have happened during the ablation of the cti line but was noticed afterwards when catheters were already pulled.A drop in bp was noted so he reinserted the soundstar to investigate.Patient fully recovered (no residual effects).The patient stayed for slightly longer in order to monitor everything and make sure nothing more arose from the event.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

It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring a pericardiocentesis.It was reported that the carto 3 system displayed a catheter sensor error (number unknown) when the pentaray catheter was plugged into the piu.They reseeded the cable and exchanged the cable and the issue persisted.They exchanged the pentaray catheter, and the issue was resolved.The case continued.It was also reported that at the end of the case, while extracting the catheters from the patient, the patient blood pressure dropped, it was lower than it was when they started.The patient was treated.The soundstar catheter confirmed the patient had a pericardial effusion.The patient was stable.A pericardiocentesis was done and 95 ml of fluid was removed from the patient.The patient did not require any surgical repair.The drain was removed from the patient and the patient is stable.The physician thinks the effusion may have occurred during ablating of the cti line just above the ivc portion.There was an impedance spike noticed and the nurse came off of the rf energy.It was a right-sided effusion.They used a total of 40 watts on the left side for the atrial fibrillation and 35- 40 watts for the cti line.They used a vizigo sheath, soundstar catheter, pentaray catheter, and stsf ablation catheter.Brk needle utilized for transseptal puncture.Correct catheter settings selected on the generator.Flow settings were 17ml/min for the st sf above 30w for irrigation.Pump switching from ¿low¿ to ¿high¿ flow during ablation.Force visualization features were graph, dashboard, vector, and visitag.Visitag parameters for stability were 2,3,25%,3 and 3mm tag size.Respiration gating was also used with an accurate respiration graph.Tag index color options were used.The physician¿s opinion on the cause of this adverse event was the procedure.It is believed to have happened during the ablation of the cti line but was noticed afterwards when catheters were already pulled.A drop in bp was noted so he reinserted the soundstar to investigate.Patient fully recovered (no residual effects).The patient stayed for slightly longer in order to monitor everything and make sure nothing more arose from the event.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.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.A manufacturing record evaluation was performed for the finished device batch number, and internal actions 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.The root cause of the adverse event remains unknown.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).

• 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: 15879976
• MDR Text Key: 304505379
• Report Number: 2029046-2022-02982
• 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
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• 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: 30807844L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2022
• 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; PENTARAY NAV ECO; SMARTABLATE GENERATOR; SOUNDSTAR; VIZIGO SHEATH
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female