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

Catalog Number D142901

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 01/22/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with an optrell mapping catheter with trueref technology and a clot-like substance was attached to the catheter tip.For premature ventricular contraction (posterior septum of right ventricular outflow tract) procedure, the optrell was used.Irrigation was performed using a pressurized bag throughout the procedure.After one or two hours later from the catheter use, the physician reported that when the optrell was removed from the patient¿s body for catheter replacement and a fine clot-like substance was attached on the dented area at the tip of the catheter.It was unknown whether the substance originated in the sheath and was pulled out or not.That clot-like substance was also discarded and could not be checked.The procedure was completed with no problems.There were no error messages or product problems.

Manufacturer Narrative

Device investigation details: 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.A manufacturing record evaluation was performed for the finished device number lot 31169380m and no internal actions related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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.E1.Initial reporter phone: (b)(6).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 20-feb-2024, additional information was received indicating the clot was found on the tip electrode in the dented area of the tip.There were no system error messages.The generator was in temperature control mode.Temperature cut off: 50¿, impedance cut off: 250o.There were no issues related to temperature or flow.The patient as anticoagulated.Activated clotting time (act): around 300.The patient has not exhibited any neurological symptoms.And the physician did not consider the clotting to be considered excessive or cause a risk to the patient.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: 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: 18699351
• MDR Text Key: 336413524
• Report Number: 2029046-2024-00483
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K230253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: D142901
• Device Lot Number: 31169380M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2023
• 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: NGEN MONITOR ASSEMBLY; NGEN PUMP, JAPAN CONFIGURATION