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

Catalog Number	D142901
Medical Device Problem Codes	Entrapment of Device (1212); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional 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.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a supraventricular tachycardia ablation procedure with a optrell mapping catheter with trueref technology and the catheter was tangled with other catheters and when pulling out the optrell¿ catheter it was noted it had a bent shaft.It was difficult to remove the optrell catheter from the sheath.There was no damage, lifted rings, or sharpened ring noted on the catheter.The catheter was replaced, and the problem was resolved.The case continued.No patient consequences were reported.
Additional Manufacturer Narrative
Per internal review on 11-nov-2025, it was identified that the product receipt date of 28-oct-2025 was mistakenly omitted from the previous initial report.The d9 section of this form has been updated accordingly.The bwi product analysis lab has received the device for evaluation.On 11-nov-2025, the product investigation was completed.It was reported that a patient underwent a supraventricular tachycardia ablation procedure with a optrell mapping catheter with trueref technology and the catheter was tangled with other catheters and when pulling out the optrell¿ catheter it was noted it had a bent shaft.It was difficult to remove the optrell catheter from the sheath.There was no damage, lifted rings, or sharpened ring noted on the catheter.The catheter was replaced, and the problem was resolved.The case continued.No patient consequences were reported.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection evaluation and dimensional test of the returned device was performed following j&j medtech procedures.Visual inspection of the returned sample revealed no damage or anomalies.The shaft was found in good condition, no bent marks were detected.A dimensional test was performed, and the results were found within specifications.A manufacturing record evaluation was performed for the finished device 31558353m number, and no internal actions related to the reported complaint condition were identified.The bent condition and resistance reported by the customer could not be confirmed during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The catheter instructions for use (ifu) contain the following recommendations: do not use excessive force to advance or withdraw the catheter through the guiding sheath if resistance is encountered.To avoid entanglement or entrapment which may result in the need for surgical intervention, exercise caution when maneuvering the catheter near the valvular apparatus and other devices.As part of the johnson & johnson medtech 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: (b)(4).

• Brand Name: OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY
• Common Device Name: 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 23416446
• Report Number: 2029046-2025-03617
• Device Sequence Number: 9028525
• Product Code: DRF
• UDI-Device Identifier: 10846835025828
• UDI-Public: (01)10846835025828(11)250324(17)280323(10)31558353M
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: D142901
• Device Lot Number: 31558353M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AGILIS 8.5 FR SHEATH; SMARTABLATE SYSTEM
• Patient Sex: Unknown