MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number	D142901
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a redo- atrial fibrillation / atrial flutter ablation (afib/afl) procedure with an optrell mapping catheter with trueref technology, the patient experienced blood pressure drop, pericardial effusion was noted, treated with pericardiocentesis with removal of 718ml fluid.The case was aborted, but atrial fibrillation ablation was conducted prior to the event.It was reported that a pericardial effusion was noticed during the procedure.Following the atrial fibrillation ablation, the patient had gone into either atrial tachycardia or atrial flutter.Then, while mapping the atrial tachycardia or atrial flutter using an optrell catheter, the patient's blood pressure dropped.A soundstar catheter was used to confirm the pericardial effusion with intracardiac echocardiography (ice).The medical intervention provided was a pericardiocentesis and 718 ml of fluid was drained.The procedure was aborted.The last known patient status was stable.The following biosense webster catheters were used during the case: decanav catheter, optrell catheter, soundstar catheter, and carto 3 system.All catheters are available for return.The carto 3 system was used for mapping and the farapulse system was used for ablation, and petal xml was used.
Additional Manufacturer Narrative
The biosense webster, inc.Product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report 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 device evaluation was completed on 13-aug-2025.It was reported that during a redo- atrial fibrillation / atrial flutter ablation (afib/afl) procedure with an optrell mapping catheter with trueref technology, the patient experienced blood pressure drop, pericardial effusion was noted, treated with pericardiocentesis with removal of 718ml fluid.The case was aborted, but atrial fibrillation ablation was conducted prior to the event.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 the carto 3 system, and it was recognized and visualized correctly.No magnetic or noise issues were found.Additionally, the device was deflected and irrigated during the test, and no issues were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.The instructions for use (ifu) states the following recommendations: when using the catheter with conventional systems (such as fluoroscopy or ultrasound imaging), or with the carto¿ 3 system, careful catheter 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.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specification.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: OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 22696700
• Report Number: 2029046-2025-02529
• Device Sequence Number: 8870104
• Product Code: DRF
• UDI-Device Identifier: 10846835025828
• UDI-Public: (01)10846835025828(11)250227(17)280226(10)31583612M
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230253
• 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): 09/08/2025

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: D142901
• Device Lot Number: 31583612M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 08/03/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• 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: CARTO 3 SYSTEM.; DECANAV CATHETER.; FARAPULSE SYSTEM.; PETAL XML CATHETER (FARAPULSE SYSTEM).; SOUNDSTAR CATHETER.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown