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

Catalog Number D134805

Device Problems Improper or Incorrect Procedure or Method (2017); Device Contamination with Body Fluid (2317); Obstruction of Flow (2423); High Readings (2459)

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

Event Date 03/07/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and one of the irrigation holes was clogged.It was reported by the caller there was char on the catheter and high impedance spikes.Caller stated the impedance spikes were cutting off the ablations.Caller stated they tried to flush the catheter but one of the holes was plugged.The catheter was replaced and the procedure continued.There was no patient consequence.Additional information received indicated the irrigation issue was noticed after using the device on the patient.There were no errors noted.The impedance threshold cut off ablation, which triggered staff to check grounding pads and catheter.Catheter was observed to have char on the tip electrode, so it was cleaned flushed and inspected.Heparinized saline was used during the case.Initially, the pump was not switching from low to high flow during ablation because the smartablate rf generator was set to the incorrect catheter settings.Once the correct settings were applied, the smartablate irrigation pump started switching from low to high flow during ablation.

Manufacturer Narrative

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.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 15-may-2024, 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).

• 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: 19044857
• MDR Text Key: 339437343
• Report Number: 2029046-2024-01133
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 31229162L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 05/15/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/08/2024
• 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: CARTO 3 SYSTEM; SMARTABLATE GENERATOR SPARE-US; SMARTABLATE PUMP SPARE-US