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

Catalog Number	D160904
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation with a octaray mapping catheter and the patient experienced asystole that required chest compressions and temporary pacing.It was reported that toward the end of the pfa (pulse field ablation) afib procedure the patient became asystolic after cardioversion.At the beginning of the case the physician used an octaray catheter creating a pre-pfa map on the carto 3 system.The octaray was removed and boston scientific farawave catheter was inserted, used to deliver "touch-up" pfa lesions around the pulmonary veins and posterior wall.The patient had received a previous cryo ablation.After the pfa portion the physician remapped with the octaray while the patient was in sinus rhythm.Coronary sinus (cs) pacing was done, during which the patient went back into afib rhythm.The medical team cardioverted the patient and at this point the patient went into asystole, this was observed on the ep (electrophysiology) recording system.The physician attempted to re-place the cs catheter for pacing, meanwhile a code was called.Chest compressions were administered, the patient was intubated, and a temporary pacing wire was placed.After about 25 minutes the patient spontaneously covered a rhythm (flutter or junctional), and the temporary pacing wire was removed.The patient was transferred to the "cbcu" for observation.The patient status was stable.Patient improved.
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 31595307l 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).
Additional Manufacturer Narrative
Per internal review on 29-jul-2025, it was determined that this event is not reportable against bwi products.The asystole can be associated with cardioversion since the asystole occurred immediately after cardioversion and cardioversions can cause a temporary pause in electrical activity.There were no malfunctions with the mapping catheter that would cause it to be a suspected device.No indication that it contributed to the adverse event.No further details will be reported for this event.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: 22438784
• Report Number: 2029046-2025-02215
• Device Sequence Number: 4632278
• Product Code: MTD
• UDI-Device Identifier: 10846835021233
• UDI-Public: (01)10846835021233(11)250310(17)280309(10)31595307L
• 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
• Report Date (Section B): 08/25/2025

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: D160904
• Device Lot Number: 31595307L
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2025
• 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: BSX FARAPULSE PFA SYSTEM.; CARTO 3 SYSTEM.; NGEN CONSOLE.; NGEN PUMP, US CONFIGURATION.; UNK_NGEN RF GENERATOR.; UNK_SOUNDSTAR.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 66 KG