MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number	D142902
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with an optrell mapping catheter with trueref technology and prior to being inserted into the body, the catheter coating was coming off and wires and hardware were exposed.The catheter was replaced and the procedure continued.The reporter stated that the faulty catheter was brand new.A replacement catheter was requested.The reporter stated that the ngen generator was used for ablation.There was no adverse patient consequence reported.Additional information indicated that the issue was found near the paddle component of the optrell.The catheter was not inserted through a sheath.The damage was noted when the catheter was removed from package.
Additional Manufacturer Narrative
The device was returned to johnson & johnson medtech (j&j) for evaluation.Visual inspection of the returned device was performed following j&j procedures.Visual inspection was performed, and the paddle's splines were observed broken with internal components exposed.The damage observed is related to the manipulation of the device during the procedure as customer reported.The component exposed issue reported by the customer was confirmed.The potential cause of the issue cannot be established.The instructions for use contain (ifu) the following warning and precaution: do not introduce the catheter into a guiding sheath with the catheter¿s distal spines folded backward toward the handle.Collapse the spines together using the insertion tube prior to insertion.Do not use excessive force to advance or withdraw the catheter through the guiding sheath when resistance is encountered.Prior to removing or repositioning the catheter, use direct imaging guidance such as fluoroscopy to confirm that the spine assembly is not entangled with another catheter or with an anatomical structure.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released 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.Manufacturer's reference number: (b)(4).

• Brand Name: OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY
• Common Device Name: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: 24186663
• Report Number: 2029046-2026-00315
• Device Sequence Number: 8131576
• Product Code: MTD
• UDI-Device Identifier: 10846835025811
• UDI-Public: (01)10846835025811(11)240917(17)270916(10)31442678M
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2026

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: D142902
• Device Lot Number: 31442678M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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: NGEN RF GENERATOR, US
• Patient Sex: Unknown