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

Catalog Number D134805

Device Problems Coagulation in Device or Device Ingredient (1096); Device Contamination with Body Fluid (2317)

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

Event Date 01/17/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the physician considered the amount of char observed caused a potential risk to the patient.Initially it was reported that the impedance was going up at times during the procedure, after checking the catheter, char was found.Removed it and checked that the irrigation on the catheter and it working fine.Continued with the procedure and a few minutes after, the same issue was experienced.Checked the catheter again and char was found for the second time.The physician requested the catheter be replaced and the issue was resolved.The procedure continued.There was no patient consequence reported.Additional information was received on 18-jan-2024.They removed char, made sure irrigation holes were all clear and rechecked act.It was located on the tip electrode.The system did not present any error messages nor did the physician/user see any product problem.No issues related to the temperature and flow on the catheter.The generator parameters were set to the default parameters and power control.Power set to 40w and 50w throughout the procedure.The correct settings were selected on the generator.The duration of the ablation used was not greater than 60 seconds.The average contact force was not greater 25 grams.No ablations over 25 grams.The irrigation rate was not used outside of those prescribed.The pre-ablation high setting was set to default settings.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.The patient was anticoagulated at 350-450 act and maintained throughout the procedure.Heparinized saline used only.The carto visitag module was used and the surpoint recommended settings were used.The color options used were tag index, impedance 5-10ohm.The impedance cut off value was not exceeded.They came off when they saw impedance rise.The user was able to use the stop button.The system did not continue to ablate above the impedance cut off value.No evidence of blood thrombus / clot during the procedure.Unaware if the patient exhibited any neurological symptoms since the procedure was completed.The physician did not specify if considered it excessive.The physician considered the amount observed caused a potential risk to the patient.He was worried about a stroke.The physician¿s opinion on the cause of the issue was product malfunction.Additional information was received on 31-jan-2024.Does not have access to any patient history or outcomes.Not aware of any patient consequence.This event was originally considered non-reportable, however, bwi became aware that the physician considered the amount of char observed caused a potential risk to the patient on (b)(6) 2024 and have reassessed the event as reportable.

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).

Manufacturer Narrative

The investigation was completed on 09-feb-2024.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31191114l and no internal actions related to the complaint was found during the review.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 atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the physician considered the amount of char observed caused a potential risk to the patient.The device evaluation was completed on 02-apr-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 char/thrombus/clot residues.The temperature, impedance, pump, and pressure gage tests were performed and the device was found working correctly.No temperature, impedance, or irrigation issues were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.Char is a physical phenomenon of radio frequency (rf), it can be the normal result of the ablation process.The instructions for use (ifu) 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 increased risk for collateral damage.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: pc-(b)(4).

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 06-mar-2024.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).

• 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: 18675985
• MDR Text Key: 336078048
• Report Number: 2029046-2024-00440
• Device Sequence Number: 1
• Product Code: LPB
• 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,Followup,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• 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: 31191114L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2023
• 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: UNK GENERATOR.; UNK PUMP.; UNK_CARTO 3.
• Patient Sex: Male