MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number UNK_OPTRELL MAPPING CATHETER

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 07/24/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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 atrial fibrillation (afib) procedure with an optrell mapping catheter with trueref technology and clotting formed on the paddle.The physician noticed that when the catheter was pulled out of the patient, clotting had formed on the paddle of the optrell mapping catheter with trueref technology.No patient consequence was reported.Additional information was received.A clot was confirmed found on the catheter.It was unknown if an ablation catheter was used during this procedure.The system did not present any error messages nor did the physician/user see any product problem.There were no issues related to temperature and flow on the catheter.The generator was set to power control mode at 50 w.The temperature, impedance and power were not noted.The patient was anticoagulated.This practice maintains an act of ~250-300 throughout the case.Not aware if the patient 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.The average contact force was not greater than 40 grams.Irrigation rate was not used outside of those prescribed.The pre-ablation high setting was unknown.Heparinized normal saline was not used as the irrigation fluid.The carto visitag module was used.The following are the settings: no resp on, 3, 3, 25%, 3.3 mm tags.The color options used was the tag index.The clotting formed on the paddle was assessed as mdr reportable.

• Brand Name: OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 17591729
• MDR Text Key: 321692044
• Report Number: 2029046-2023-01813
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835023022
• UDI-Public: 10846835023022
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 08/21/2023

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: UNK_OPTRELL MAPPING CATHETER
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; UNK_CARTO 3