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

Catalog Number	D160901
Medical Device Problem Codes	Device-Device Incompatibility (2919); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation and the patient experienced hypotension and bleeding that required blood transfusion.It was reported that they were advancing the farawave¿ pfa catheter back into the body when the anesthesiologist stated the patient blood pressure has dropped (50/40).The procedure was stopped.The patient's hemoglobin was checked, and it also dropped (3-4 points).Xray and contrast were used to locate the bleed, they were unsuccessful and the patient was taken to a ct scan (computed tomography).The medical intervention was administering blood; however, it was unknown if any medications were given.The patient last known status was stable and intubated.Earlier in the case, they were uncertain and worried that there may have been a perforation when they had trouble advancing the octaray¿ catheter.It kept getting stuck, so it was removed.They then attempted to advance the wire and they experienced difficulty.The sheath was replaced and they were able to advance the wire.The physician was unsure on the cause of the event.He thought it may have occurred early in the case when he was having difficulty advancing the octaray¿ and changed over to a wire to advance up to the heart.The patient¿s blood pressure was dropping earlier in the case as well; however, it was not low enough for concern.The doctor first mentioned checking the blood pressure earlier in the case when advancing the octaray.The faradrive sheath was used and they did not think anything was wrong with the sheath.
Additional Manufacturer Narrative
It was reported that the patient experienced hypotension and bleeding that required blood transfusion.Device investigation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection and revision of all device features were performed.Visual inspection revealed no damage or anomalies on the device.The device was connected to carto 3 system, and it was recognized and visualized correctly.No magnetic or noise issues were found.Also, device was deflected and irrigated during the test and no issues were observed.Additionally, the device¿s outer diameters were inspected and found within specifications.Furthermore, the device was passed through a sample sheath (vizigo) and no resistance was encountered.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The resistance issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the use of the device that may have affected its performance.The root cause of the adverse event remains unknown.The instructions for use (ifu) states the following recommendations: do not use excessive force to advance or withdraw the catheter through the guiding sheath if resistance is encountered.Careful manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade.Catheter advancement and placement should be done through a guiding sheath under direct imaging guidance such as fluoroscopy or ultrasound.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: 24691045
• Report Number: 2029046-2026-00975
• Device Sequence Number: 13174964
• Product Code: MTD
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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: D160901
• Device Lot Number: 31818289L
• Date Returned to Manufacturer: 03/25/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female