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

Model Number D134805

Device Problems Device Contamination with Body Fluid (2317); High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Transient Ischemic Attack (2109)

Event Date 09/13/2022

Event Type  Injury  

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 4.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 ref.# (b)(4).

Event Description

It was reported that a patient underwent a persistent atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered transient ischemic attack (tia) and could not move their left leg and arm.After the procedure the patient had difficulty waking up and they could not move their left leg and arm.- an urgent head ct was done but the patient was moving too much to get a clear image.A neurologist was called in to perform a cerebral angiogram.No clot/blockages were found.The patient was taken back to intensive care unit (icu).A few hours later, the doctor visited the patient and said that he was awake and had full movement in his arms/legs, was talking and eating.The procedure was successfully completed and not delayed.Additionally, it was reported there was an impedance rises on the ablation catheter when ablating near the left atrial septum.The temperature within normal range, impedance 90-130ohms, - power 40w, generator in power control mode & force within normal limits 5-20grams.The patient received 9,000 units of heparin given throughout procedure to achieve an activated clotting time (act) result of >350 throughout case.The catheter was removed and there was char on the catheter (spotted by the physician).The doctor removed the char and flushed the catheter.Catheter seemed to be irrigating appropriately.Went back to the left atrium (la) to ablate.Impedance rises noted again and they replaced the catheter.No more impedance rises noted for the remainder of the case.Information was later received indicating this adverse event was discovered post use of biosense webster products.The physician¿s opinion on the cause of this adverse event is that it was due to the procedure.Intervention provided was ct scan of brain and cerebral angiogram performed post procedure.No abnormalities were found.Patient has fully recovered.It is unknown if the patient required extended hospitalization because of the adverse event.The char /coagulum/thrombus/clot was located on tip electrode ¿ on the tip.No errors or issues noted with the system.There was a slight impedance rise when ablation on the septum.This was pointed out by the bwi representative, and the catheter was checked after this impedance rise.There were no issues related to temperature and flow on the catheter.Generator parameters were temperature mode, 40 w, and thresholds were within the normal limits and set as per instructions for use (ifu).The patient has not exhibited any neurological symptoms since the procedure was completed.Correct catheter settings were selected on the generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.Contact force is kept between 5g-20g.An irrigation rate outside of those prescribed was not used.The pre-ablation high setting was 1 sec of pre ablation high flow.Heparinized normal saline used as the irrigation fluid.The carto visitag module was not used.The impedance cut-off value was not exceeded, only slight increased noticed by bwi sales consultant.The ablation was stopped by the physician when he took his foot off the pedal after seeing that the impedance has increased.They are unsure what the impedance was but in the low 100 ohms.The customer¿s reported issue of high impedance is not mdr reportable since the user-defined cut-off was not exceeded the the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, is remote.The customer¿s reported issue of char is a physical phenomenon of radiofrequency ablation and can be a normal result of the ablation process.The presence of char does not by itself represent a serious injury, nor is it necessarily the result of a device malfunction.As such, char is not mdr reportable.

Manufacturer Narrative

On 20-oct-2022, the bwi product analysis lab received the complaint device for evaluation.The product 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.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On 20-feb-2023, additional information was received indicating that during the procedure, there was found char in the tip section; gauze was used to remove it.Device evaluation details: the thermocool® smart touch® sf bi-directional navigation catheter 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 correctly.During the patency test, some irrigation holes did not irrigate.Dome was dissected and foreign material was found occluding irrigation holes.A fourier transform infrared spectroscopy test (ftir) was performed and the results revealed that foreign material exhibited the infrared spectrum for polyester-based material with second component presumably a silicone-base material.Source of origin cannot be determined.A manufacturing meeting was performed to verify the dome occlusion issue and it was concluded, in regards of foreign material detected encapsulated inside the dome, it was determined that none of the manufacturing process agents can be associated to the composition of foreign materials found.Therefore, this issue cannot be considered as manufacturing related.The root cause of the foreign material could be related to the handling of the device.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.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.Explanation of codes: investigation findings: operational problem identified (c13) / investigation conclusions: cause not established (d15) / component code: dome (g04046) were selected as related to the irrigation issue identified during analysis.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer's reported adverse event, char and high impedance issues.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 15592013
• MDR Text Key: 301632999
• Report Number: 2029046-2022-02501
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• 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: 30822343L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2022
• 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: UNKNOWN GENERATOR.; UNKNOWN PUMP.
• Patient Outcome(s): Other