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 Codes	Low Blood Pressure/ Hypotension (1914); Respiratory Failure (2484)
Date of Event	10/30/2024
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 hypotension and respiratory failure that required medication.First, it was reported that the ngen ethernet cable displayed physical damage.The plastic connection tab on the ethernet cable was broken and the cable was unable to be secured into the ngen monitor.No damage to the other ngen components were visible.Then it was reported that after doing a single transeptal and mapping the left atrium, the patient o2 saturation and blood pressure dropped.No ablation had occurred.The patient was placed on medicines to help with symptoms and will be performing a ct scan for suspected pulmonary thrombus.Further intervention is unknown.The patient fully recovered and did not require extended hospitalization.The physician's opinion on the cause of the adverse event is the patient condition.Stsf catheter was opened but not used.
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
Per internal review on 23-dec-2024, it was identified that there were details mistakenly omitted from the previous supplemental report.On 4-dec-2024, bwi received additional information indicating that the hospital was unable to confirm the pulmonary embolism with diagnostic tests but the doctor believes that is what happened.He said it must have been small enough to be transient and perhaps it dissolved.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
On 28-nov-2024, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an atrial fibrillation ablation with a octaray mapping catheter and the patient experienced hypotension and respiratory failure that required medication.First, it was reported that the ngen ethernet cable displayed physical damage.The plastic connection tab on the ethernet cable was broken and the cable was unable to be secured into the ngen monitor.No damage to the other ngen components were visible.Device evaluation details: the product was returned to johnson & johnson medtech (j&j medtech) for evaluation.A visual inspection and revision of all features were performed following j&j medtech procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device number lot 31380840l and no internal action related to the complaint was found during the review.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.No error messages were observed on johnson & johnson medtech equipment during the procedure.The physician's opinion on the cause of the adverse event is the patient condition.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 20774102
• Report Number: 2029046-2024-03799
• Device Sequence Number: 19933348
• Product Code: MTD
• UDI-Device Identifier: 10846835021233
• UDI-Public: (01)10846835021233(11)270703(10)31380840L
• 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): 12/23/2024

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: 31380840L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 11/28/2024; 12/23/2024
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 12/23/2024; 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2024
• 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: 8.5F SHEATH WITH CURVE VIZ MDC.; CARTO 3 SYSTEM.; NGEN PUMP, US CONFIGURATION.; NGEN RF GENERATOR, US.; SOUNDSTAR ECO SMS 8F CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Race: White