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

Model Number D134804

Device Problems Device Contamination with Body Fluid (2317); Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Thrombosis/Thrombus (4440)

Event Date 07/12/2022

Event Type  Injury  

Event Description

It was reported that a female patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf).The patient suffered a cerebrovascular accident, thrombosis in the left atrium, prolonged hospitalization and surgical intervention.About fifteen minutes into ablation, the physician noticed a clot in the left atrium (la) on ultrasound.The bwi representative also noticed the ablation catheter was not irrigated at this time.The ablation catheter settings then were discovered to be set to a 4mm setting on the smartablate while using an stsf catheter.The settings were programed to 40 watts, 55 degrees celsius and total time cut off at 999 seconds.The physician removed the ablation catheter from the patient and inspected char on the tip of the ablation catheter, and then aborted the procedure.The physician evaluated the patient and observed left sided weakness.The patient was sent to ct for stroke evaluation.The patient was otherwise stable.It was also reported that the carto 3 system displayed error 6150: magnetic sensor error when the soundstar catheter was plugged into the patient interface unit.To troubleshoot, the eco cable was replaced without resolution.The catheter was replaced, the issue was resolved, and the procedure was continued.Additionally, the bwi representative reported that the ecg lead v2 was completely ripped off when moving the patient.The physician¿s opinion on the cause of this adverse event was that it was not a bwi product malfunction.Patient was to have ct scan to evaluate stroke symptoms.The patient outcome of the adverse event was improved.The patient received intervention for clot removal.The patient was under general anesthesia for approximately one hour.A transseptal puncture was performed prior to the case cancellation.The physician¿s opinion regarding the cancelation of the procedure was that it contributed to a serious injury to the patient as the patient had a stroke.The patient required extended hospitalization due to a medical condition caused by procedure cancellation to observe for additional clot in la.There was char observed on the tip of the electrode.The system did not present any error messages and the physician did not see any product problem.There were no issues related to the temperature and flow on the catheter.The generator parameters were set on temperature control mode.The patient was anticoagulated.The generator used was a smartablate and the pump used was a smartablate pump.There were no issues related to the pump.Since cerebrovascular accident and thrombosis may be life threatening, it is mdr reportable.Char was assessed as not mdr reportable.Char is a physical phenomenon of radiofrequency (rf) energy delivery and can be the normal result of the ablation process.The presence of char on the electrodes does not represent a serious injury in itself, nor is it necessarily the result of device malfunction.In addition, biosense webster inc.Has reassessed the reportability of char-related events and has determined that these events, which were previously reported as malfunctions, are ¿not reportable.¿ the fda has provided documented concurrence with this assessment.The magnetic sensor error and cable problem were assessed as not mdr reportable.The potential risk that it could cause or contribute to a serious injury or death is remote.

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

Manufacturer Narrative

The device evaluation was completed on (b)(6) 2022.It was reported that a female patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf).The patient suffered a cerebrovascular accident, thrombosis in the left atrium, prolonged hospitalization and surgical intervention.About fifteen minutes into ablation, the physician noticed a clot in the left atrium (la) on ultrasound.The bwi representative also noticed the ablation catheter was not irrigated at this time.The ablation catheter settings then were discovered to be set to a 4mm setting on the smartablate while using an stsf catheter.The settings were programed to 40 watts, 55 degrees celsius and total time cut off at 999 seconds.The physician removed the ablation catheter from the patient and inspected char on the tip of the ablation catheter, and then aborted the procedure.The physician evaluated the patient and observed left sided weakness.The patient was sent to ct for stroke evaluation.The patient was otherwise stable.It was also reported that the carto 3 system displayed error 6150: magnetic sensor error when the soundstar catheter was plugged into the patient interface unit.To troubleshoot, the eco cable was replaced without resolution.The catheter was replaced, the issue was resolved, and the procedure was continued.Additionally, the bwi representative reported that the ecg lead v2 was completely ripped off when moving the patient.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.The device was visually inspected, and it was found in good condition.However, cg labs provided a picture of the char attached to the device's tip.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 30764818l number, and no internal actions related to the reported complaint condition were identified.The char issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The evaluation determined that char is a physical phenomenon of radiofrequency (rf).The instructions for use contain the following recommendations: when rf current is interrupted for either a temperature or an impedance rise (the set limit is exceeded), the catheter should be removed, and the tip cleaned of coagulum if present.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15184734
• MDR Text Key: 297460883
• Report Number: 2029046-2022-01815
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2023
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30764818L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2022
• 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: BS CABLES SET,2M TRUNK + LEADS; CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US; SOUNDSTAR ECO SMS 10F CATHETER; UNK BRAND CABLE; UNK BRAND CATHETER; UNK TRANSSEPTAL NEEDLE
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Female