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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Air Embolism (1697); Ischemic Heart Disease (2493)

Event Date 02/02/2023

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.Biosense webster manufacturer's reference number pc-001287339 has three reports: (1) mfr # 2029046-2023-00446 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).(2) mfr # 2029046-2023-00447 for product code d138502 (carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium).(3) uf/importer report number # 2029046-2023-50006for product code m490008 (smartablate¿ system irrigation pump (us)).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with the following devices: thermocool® smart touch® sf bi-directional navigation catheter (stsf), smartablate¿ system irrigation pump (us), and carto vizigo¿ 8.5f bi-directional guiding sheath - medium.The patient suffered an air embolism and electrocardiogram st segment elevation.It was reported that during an ablation procedure they received a bubble error alert triggered by the smartablate pump.They went to troubleshoot the issue and noticed "the bag had run dry" and so they "hung a new bag".Upon trying to flush the new bag, they left the wrong line open and when they tried to flush through, they flushed through the line still connected inside the patient causing an embolism.The injury was confirmed via ekg monitoring and the stsf catheter showed "st elevation" through the cool flow.There was no medical intervention directly provided however the physician observed the patient until the embolism resolved, and the procedure continued.The patient was stable at the time of the call.The stsf catheter is available for return.The stsf catheter was being used with a vizigo sheath, product code d138502 (lot number unknown).Pump used was a stockert gmbh smartablate system irrigation pump (sn g4cp-2042).Service was not needed.The adverse event was discovered during use of biosense webster products.The physician confirmed that the event occurred due to him having the wrong flush line open for re-flushing/priming the stsf smart ablate tubing, and air embolus traveling to patient instead of being flushed out of the line.The patient fully recovered/no residual effects.The patient did not require extended hospitalization because of the adverse event.The patient has a history of atrial fibrillation.Generator used was a stockert gmbh smartablate system rf generator (sn (b)(4)).

Manufacturer Narrative

The device evaluation was completed on 03-mar-2023.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with the following devices: thermocool® smart touch® sf bi-directional navigation catheter (stsf), smartablate¿ system irrigation pump (us), and carto vizigo¿ 8.5f bi-directional guiding sheath - medium.The patient suffered an air embolism and electrocardiogram st segment elevation.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.A manufacturing record evaluation was performed for the finished device 30934978l number, and no internal action related to the complaint 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.Biosense webster manufacturer's reference number (b)(4) has three reports: (1) mfr # 2029046-2023-00446 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter) (2) mfr # 2029046-2023-00447 for product code d138502 (carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium) (3) uf/importer report number # 2029046-2023-50006 for product code m490008 (smartablate¿ system irrigation pump.(us)).

• 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: 16474068
• MDR Text Key: 310585469
• Report Number: 2029046-2023-00446
• 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: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• 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: 30934978L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2022
• 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: 8.5F SHEATH WITH CURVE VIZ MDC; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US
• Patient Outcome(s): Life Threatening
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 119 KG