MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number	D160903
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with an octaray mapping catheter.And an irrigation issue (device used in patient) was observed.No error code was displayed.Reflux was not flowing properly from the pressure bag.It is suspected that the inside of the octaray mapping catheter may have been damaged.Since it was near the end of the procedure, the procedure was decided to finish as it was.The procedure was completed without patient's consequence.Additional information was received.The suspected device for the reported flow/irrigation issue was the catheter.The device was used in the patient.No pump was used.No error.Adequate irrigation was not observed during pressure bag¿assisted catheter irrigation.No steps taken to resolve the irrigation issue since it was near the end of the procedure, the procedure was decided to finish as it was.Since the issue was related to octaray mapping catheter, it was not related to the generator.
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).
Additional Manufacturer Narrative
It was reported that a patient underwent a cardiac ablation procedure with an octaray mapping catheter.And an irrigation issue (device used in patient) was observed.The device evaluation details.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation on 19-nov-2025.Visual inspection and irrigation test of the returned device were performed following j&j medtech procedures.Visual analysis revealed no damage or anomalies on the device.An irrigation test was performed, and the catheter failed the test due to the irrigation tube was found bent inside the tip.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The irrigation issue reported by the customer was confirmed.The potential cause of the bent could not be conclusively determined.The instructions for use contain the following recommendations: flush the catheter with heparinized normal saline prior to insertion into the body and ensure that saline flows through the distal end of the irrigation lumen.As part of johnson & johnson medtech's 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: OCTARAY MAPPING CATHETER
• 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: 23550537
• Report Number: 2029046-2025-03794
• Device Sequence Number: 13144336
• Product Code: MTD
• UDI-Device Identifier: 10846835021127
• UDI-Public: (01)10846835021127(11)250708(17)280707(10)31702612L
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193237
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2025

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: D160903
• Device Lot Number: 31702612L
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2025
• 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
• Patient Sex: Unknown