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

Model Number D134805

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 10/05/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).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 reference number: pc-(b)(4).

Event Description

It was reported that an unknown patient underwent an cardiovascular procedure ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The catheter showed a reduction in the flow of some of the lateral holes that deliver the irrigation, forming a clot at its tip.There was a need to change the material and delay because of this problem.There was no harm to the patient.It is important to report that when starting the procedure, the tca collection limit was below the indicated value of 350, it was 250.Surgery was not delayed due to the reported event.Procedure was successfully completed.Fragments were generated.They weren¿t removed easily without additional intervention.Clot were formed.No patient consequences.There was no neurological impairment after the procedure.The char /coagulum/thrombus/ clot was located in the tip of electrode.The system did not show any error.It just increased the impedance, and the catheter was removed soon afterwards.There was a reduction in the irrigation flow of the catheter.There was no error on the irrigation pump.The catheter was removed when an increase in impedance was observed.The step taken to resolve the irrigation issue was catheter exchange.Thrombus/clot is mdr-reportable.

Manufacturer Narrative

On 12-dec-2022, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.Device evaluation details: the device was visually inspected, and the rocker arm was found detached.Welding points were observed on the handle area.Char was not found, and it was not confirmed by the cg labs in the returned catheter.Temperature, impedance, and cool flow testing were performed in accordance with bwi procedures.The catheter passed the temperature, impedance, and irrigation tests, within specification.The evaluation determined that char is a physical phenomenon of rf.The instructions for use contain the following instruction: in the event of a impedance or temperature cutoff, the catheter must be withdrawn, and the tip electrode inspected for coagulum before rf current is reapplied.Remove any coagulum with a sterile gauze pad dampened with sterile saline.The event described could not be confirmed as the device performed without any issues.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.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: 15724242
• MDR Text Key: 307204465
• Report Number: 2029046-2022-02718
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30844113L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2022
• 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: CARTO 3 SYSTEM; CARTO VISITAG MODULE; SMARTABLATE GENERATOR; SMARTABLATE PUMP