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 Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A picture was received for evaluation following johnson & johnson medtech (j&j medtech) procedures.According to the picture provided by the customer, the splines of the optrell catheter were observed twisted/squashed.This condition could be related to the handling of the device during the procedure, since according to the information provided, when the last catheter was moved from the vena cava inferior to the ventricle, the his catheter was by accident moved and the tip went through the optrell splines.No external damages were observed on the electrodes of the optrell catheter.The lot number was not provided; therefore, the manufacturing record evaluation cannot be performed.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly, and any action will be taken if necessary.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.
Additional Manufacturer Narrative
A picture was received for evaluation following johnson & johnson medtech (j&j medtech) procedures.According to the picture provided by the customer, the splines of the optrell catheter were observed twisted/squashed.This condition could be related to the handling of the device during the procedure, since according to the information provided, when the last catheter was moved from the vena cava inferior to the ventricle, the his catheter was by accident moved and the tip went through the optrell splines.No external damages were observed on the electrodes of the optrell catheter.The lot number was reported as unavailable.Therefore, the manufacturing record evaluation cannot be performed.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly, and any action will be taken if necessary.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H6.Investigation findings code of "appropriate term/code not available (c22)" represents photo/video analysis.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).

• 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: 23296675
• Report Number: 2029046-2025-03437
• Device Sequence Number: 9917459
• Product Code: DRF
• UDI-Device Identifier: 10846835025828
• UDI-Public: 10846835025828
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 8.5F SHEATH WITH CURVE VIZ MDC; UNK_WEBSTER CS WITH AUTO ID; UNK_WEBSTER CS WITH AUTO ID; UNK_WEBSTER CS WITH AUTO ID
• Patient Sex: Unknown