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

Catalog Number	D160906
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Respiratory Failure (2484)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation with an octaray mapping catheter, and the patient experienced acute respiratory distress that required intubation and hypotension that required medication.It was reported that during a pfa atrial fibrillation case (although no pfa application was administered to the patient), mucus was noticed in the patient's left lung.After they had gone transseptal with a baylis energy needle and sl1 sheath and began mapping in the left atrium with the octaray mapping catheter, it was noticed that there was a decrease or decompensation in the patient's blood pressure.The patient's blood pressure was reading around the 50's over 30's, but the caller could not confirm this information.Cardiothoracic (ct) surgery was consulted, and a ct scan was ordered for the patient.It was confirmed via ct scan that no perforation was present in the patient, but there was mucus confirmed to be in the patient's left lung.Blood pressure medication was administered to the patient; however, no details regarding the medication or the dosage were provided.The patient was then intubated and transferred to the medical intensive care unit (icu).The patient was last reported to be in stable condition.The caller noted that a webster® cs bi-directional catheter and a soundstar® catheter were also placed in the patient's body at the time.Additional information was received.The physician¿s opinion on the cause of this adverse event was caused due to mucus in the left lung.Extended hospitalization was reported, and the patient stayed in the icu for 1 night, was transferred to a stepdown unit for 1 night, then was discharged.A ct scan, and unsure of any other tests that were done.The patient fully recovered.There was no bwi ablation catheter used during the event, and the adverse event was noticed while using the octaray catheter, webster cs catheter, and the soundstar catheter.
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
The investigation was completed on 31-may-2025.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 31528264l and no internal action related to the complaint was found during the review.However, if the product is received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed 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).
Additional Manufacturer Narrative
During an internal review on 23-jul-2025, noted a correction to the 3500a initial under the d4.Primary udi number as it should have been processed as (b)(4).Therefore, corrected this field.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: 22021722
• Report Number: 2029046-2025-01541
• Device Sequence Number: 8815416
• Product Code: MTD
• UDI-Device Identifier: 10846835021134
• UDI-Public: (01)10846835021134(11)241204(17)271203(10)31528264L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: D160906
• Device Lot Number: 31528264L
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 05/31/2025; 07/23/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/09/2025; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2024
• 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: BAYLIS NEEDLE; CARTO 3 SYSTEM; FARAPULSE SYSTEM; SL1 SHEATH; SOUNDSTAR CATHETER; WEBSTER CATHETER
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White