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

Catalog Number	D160901
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device lot number 31617965l and no internal action 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.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with an octaray mapping catheter and some kind of adhering substance was found.During right atrium (ra) mapping, octaray did not rise to the superior vena cava (svc).When octaray was taken out of the patient ¿s body to switch to a wire guide, some kind of adhering substance was found on the spine of the octaray.Color and shape of the adhering substance: it wound around the spine at about one-third of the height from the base of octaray2-2-2.The size was approximately 1 cm when spread out, and it was white, resembling a chiari net-like mesh.Physician's opinion: a chiari net was suspected, but it could not be confirmed through intracardiac echo or body surface echo, so it is unclear what the substance is.There were no issues with the vital signs during the procedure.Both during the procedure and the body surface echocardiography before the patient left the room, there were no abnormalities.Before ra mapping, the intracardiac echo with soundstar was performed but the chiari network could not be confirmed.Despite confirming valve motion during the body surface echocardiography during the procedure, and before patient left the room, there were no changes.No cardiac tamponade observed, and no changes in hemodynamics.No extended hospitalization required.The patient was discharged without any symptoms.No adverse patient consequence was reported.The product will not be returned due to the hbv (hepatitis b virus) (+) patient.
Additional Manufacturer Narrative
Additional information was received on 29-jul-2025.It was indicated that the physician did not feel any resistance while introducing or retracting the catheter from the sheath.There was no damage found.The catheter was used as usual after removing the foreign material.The packaging, the catheter and the foreign material had been discarded because of the hbv (hepatitis b virus) (+) patient.No picture is available of foreign material.The foreign material was white, 1 cm long, mesh-like tissue.The material that was observed on the device was loose (with movement).It was adhered to the catheter but came off easily.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: 22638414
• Report Number: 2029046-2025-02464
• Device Sequence Number: 14750962
• Product Code: MTD
• UDI-Device Identifier: 10846835021141
• UDI-Public: (01)10846835021141(11)250331(17)280330(10)31617965L
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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: D160901
• Device Lot Number: 31617965L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2025
• 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: UNK_CARTO 3; UNK_SOUNDSTAR
• Patient Sex: Unknown