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

Model Number D134805

Device Problems Image Orientation Incorrect (1305); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Date 12/07/2022

Event Type  Injury  

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.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a 70 year-old female patient underwent a typical atrial flutter ablation & pulmonary vein isolation (pvi) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac perforation requiring surgery.It was reported that a cardiac perforation occurred during the procedure.The biosense webster inc.(bwi) representative reported that after the atrial flutter procedure was completed and after the physician had gone transseptal, the physician was unable to move the ablation catheter posteriorly.They reported that the physician got a transseptal puncture using an sl1 sheath, put the wire across the puncture site, and followed that with an agilis sheath and the ablation catheter.The ablation catheter was inserted into the patient first through the agilis sheath and positioned in what the physician thought was the left atrium.The ablation catheter appeared to be anteriorly positioned in the chamber of the left atrium on the carto 3 system.The lasso catheter was then inserted into the patient via the sl1 sheath and they used the lasso catheter to map the left atrium without issue.When the physician attempted to use the ablation catheter to perform the pvi procedure, the physician was unable to move the ablation catheter posteriorly.When the physician attempted to manipulate the ablation catheter, the force reading of the ablation catheter on the carto 3 system was reading anteriorly but the force vector of the ablation catheter was pointed posteriorly.They reported that the physician believed the ablation catheter to be posterior when looking at fluoro.Physician also maneuvered the lasso catheter into all four veins to confirm the position of everything and there were no issues found.They replaced the ablation catheter cable and the issue persisted.They opened a new ablation catheter to replace the ablation catheter but when the physician attempted to remove the ablation catheter, the physician was unable to draw back blood or anything into the agilis sheath.They also reported that the replacement catheter was opened but never put into the patient and that after further inspection by the physician via ice and fluoro, it was discovered that the ablation catheter and the agilis sheath were not in the left atrium.The procedure was aborted.It was reported that the echo team was called in and a tee probe was placed into the patient to verify the position of the agilis sheath and the ablation catheter.The cardio doctor confirmed that the agilis sheath was not in the left atrium.The agilis sheath was trapped in the tissue between the left atrium and the aorta.The cardiothoracic surgery team was called in on standby while they removed the agilis sheath from the patient.The agilis sheath was removed without any issue and the patient was kept under tee observation for 20 minutes and had no change of status and was transferred to icu to be monitored.The patient was reported to be in stable condition throughout the entire procedure and after the procedure was aborted.During the procedure there were no errors displayed on the carto 3 system, there was no map shift on the carto 3 system, the patient did not move, the patient's anatomy was confirmed to be correct, the metal values were confirmed to be fine, and there was no indication of high force.A replacement catheter was requested.Analysis was requested for the catheter inside of the body when the injury occurred.No service was requested.The physician believed that when attempting to "buddy across that transeptal access site" that the agilis sheath had been "wiggled" into another space.The catheter most closely involved was cat# d134805, lot#30902755l.The adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was that it was procedure related.Intervention provided was interdepartmental support from several other medical team, including tee, cardiac cath and cardiothoracic surgery.The outcome of the adverse event was fully recovered.The patient was kept in the intensive care unit (icu) overnight for observation.In the physician¿s opinion, the cancelation of the procedure did not contribute to a serious injury to the patient.Relevant tests/laboratory data-vitals monitored throughout; fluoroscopy and ultrasound imaging used throughout.There were no other relevant history reported.Generator information- smartablate sn: (b)(4), no servicing needed.Prior ablation was performed in right atrium for cti flutter.No ablation was performed after time of transseptal access.No evidence of a steam pop.The event occurred during the mapping phase.The flow setting for the irrigated catheter used was default low flow stsf setting (2ml/min).Correct catheter settings was selected on the generator.The pump flow switch was functioning properly.There were no system errors displayed at the time of the event.Force visualization features used were¿ graph, dashboard, and vector.Parameters for stability for the visitag module used were 2.5mm, 3s, 25%, 3g and 3mm tag size.Additional filter used with the visitag was respiratory gating.Color options used prospectively was tag index.The force vector inverted issue is not mdr reportable.Despite the incorrect force vector visualization, the device can function as intended, because the catheter can still be displayed using fluoroscopy and carto 3 navigation system.The risk to the patient is low.Since the event (cardiac perforation) 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

The device evaluation was completed on 10-jan-2023.It was reported that a 70 year-old female patient underwent a typical atrial flutter ablation & pulmonary vein isolation (pvi) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac perforation requiring surgery.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 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 30902755l number, and no internal action was found during the review.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).

• 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: 16100390
• MDR Text Key: 306679893
• Report Number: 2029046-2023-00025
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

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
• Device Lot Number: 30902755L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 01/05/2023
• Supplement Dates Manufacturer Received: 01/10/2023
• Supplement Dates FDA Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2022
• 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: SMARTABLATE GENERATOR KIT-US.; THMCL SMTCH SF BID, TC, D-F.; UNK AGILIS SHEATH.; UNK BRAND CABLE.; UNK BRAND CABLE.; UNK SL1 SHEATH.; UNK_CARTO 3.; UNK_LASSO.
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 70 YR
• Patient Sex: Female