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

Catalog Number	D160901
Medical Device Problem Codes	Entrapment of Device (1212); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with octaray mapping catheter.During mapping, the octaray mapping catheter spline became caught on a mechanical valve.Timing was during post mapping.The octaray mapping catheter was removed using a snare.Progress was reported as the spline was removed intact without fracturing; therefore, there was no impact onto the patient.No prolongation of hospitalization.The physician was aware that use on a mechanical valve is contraindicated and had been manipulating the catheter cautiously, but it nonetheless became caught.There were no abnormalities observed prior nor during use of the product.There was no patient consequence reported.Additional information was received which indicated that the octaray mapping catheter was removed intact without detaching the splines.
Additional Manufacturer Narrative
An analysis of the product could not be performed since a physical sample was not received for evaluation.Investigation is in progress, once completed a supplemental will be submitted.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
The investigation was completed on 02-feb-2026.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 number lot 31731940l and no internal actions related to the complaint were found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition.If the product is received at a later date, the investigation will be updated as applicable.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: 23924151
• Report Number: 2029046-2025-04349
• Device Sequence Number: 9013284
• Product Code: MTD
• UDI-Device Identifier: 10846835021141
• UDI-Public: (01)10846835021141(11)250806(17)280805(10)31731940L
• 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): 02/02/2026

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: D160901
• Device Lot Number: 31731940L
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2025
• 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 Age: 62 YR
• Patient Sex: Male