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

Catalog Number D134805

Device Problems Insufficient Cooling (1130); Device Contamination with Body Fluid (2317); Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

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 patient underwent an ischemic ventricular tachycardia (isvt) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and there was an issue of flow not properly working.After ablating with this thermocool® smart touch® sf bi-directional navigation catheter, they began to build up char and the char became so bad that the flow was no longer properly working on the catheter.During this time, the temperature would rise when they were on ablation to the point that the smartablate generator would cut off ablation.To troubleshoot the caller did a high flow flush on the catheter with no resolution.They replaced the thermocool® smart touch® sf bi-directional navigation catheter and the issue was resolved.No patient consequence reported.Additional information was received.No error, temperature rise, when they removed the catheter from the body the flow appeared inhibited.The irrigation issue occurred during the procedure.The temperature did not exceed the cut off values.The system shut off immediately.The material causing the obstruction was char.The char was located on the ablation distal electrode.The system did not present any error messages nor did the physician/user see any product problem while the catheter was being passively used while not ablating.Flow appeared restricted and the temperature rose on ablation.The generator was set to smart touch sf settings.The correct catheter settings were selected on the generator.The noted settings were baseline, impedance ~120, temperature ~37c and power~35w.The duration of ablation was not greater than 60 seconds.The pre-ablation high setting was set to 5s.The impedance drop color option was used.The pump did switch from ¿low¿ to ¿high¿ flow during ablation.The irrigation rate was not used outside of those prescribed.The patient was anticoagulated at >300.The heparinized normal saline was used.The patient did not exhibit any neurological symptoms since the procedure was completed.Improper temperature monitoring based on the smart touch sf design.The physician did not consider the amount of char observed caused a potential risk to this patient.However, they replaced the catheter to continue the procedure.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 18-dec-2023.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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) procedure with a thermocool® smart touch® sf bi-directional navigation catheter.After ablating with this thermocool® smart touch® sf bi-directional navigation catheter, they began to build up char and the char became so bad that the flow was no longer properly working on the catheter.During this time, the temperature would rise when they were on ablation to the point that the smartablate generator would cut off ablation.To troubleshoot the caller did a high flow flush on the catheter with no resolution.They replaced the thermocool® smart touch® sf bi-directional navigation catheter and the issue was resolved.No patient consequence reported.Additional information was received.No error, temperature rise, when they removed the catheter from the body the flow appeared inhibited.The irrigation issue occurred during the procedure.The temperature did not exceed the cut off values.The system shut off immediately.The material causing the obstruction was char.The char was located on the ablation distal electrode.The patient did not exhibit any neurological symptoms since the procedure was completed.The physician did not consider the amount of char observed caused a potential risk to this patient.The device evaluation was completed on 08-jan-2024.The device was returned to biosense webster (bwi) for evaluation.Visual inspection, temperature, impedance, and pump and pressure gage test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device; however, according to the picture provided by the decontamination lab, char was detected.The temperature and impedance test was performed and the device was found working correctly.No temperature or impedance issues were observed; however, during the pump and pressure gage test, an occlusion was detected.Further investigation revealed char material residues in the dome occluding the irrigation holes.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The char residues could be related to the temperature and irrigation issue reported by the customer; therefore, the customer complaint was confirmed.Char is a physical phenomenon of radio frequency (rf), it can be the normal result of the ablation process.The instructions for use contain the following recommendations: monitoring the temperature from the electrode during the application of rf current ensures that the irrigation flow rate is being maintained.Using tip temperature to guide ablation could result in deeper lesions and an increased risk for collateral damage.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi¿s quality system.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: 18308079
• MDR Text Key: 330260189
• Report Number: 2029046-2023-02911
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31151918L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2023
• 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; SMARTABLATE PUMP KIT-US; THMCL SMTCH SF BID, TC, D-F; THMCL SMTCH SF BID, TC, F-J; UNK CATHETER CABLE; UNK_CARTO 3