MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DECANAV; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number	R7D282CT
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
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 31678156m 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.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition.If the product is received at a later date, the investigation will be updated as applicable.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 a premature ventricular contraction procedure with a decanav catheter and suffered a cardiac tamponade which required a pericardial drainage.It was reported that when pacing was performed with the qdot micro catheter, the body surface ecg in the carto 3 and the lab was significantly attenuated, and pace map was unable to be performed.The cable and the qdot micro catheter were replaced.At that time, the patient¿s blood pressure decreased, and cardiac tamponade occurred.Drainage was performed, and the procedure was terminated as it was.It was unknown whether replacing the cable and the catheter improved the attenuation problem.Intracardiac echocardiography revealed the cardiac tamponade, and the pericardial drainage was performed.The decanav catheter and the qdot micro catheter were maneuvered in the right ventricular outflow tract (rvot), the collected blood was venous.After the treatment, there were no problems with the patient¿s consciousness or condition.The procedure was terminated.The physician assessment of the health problem was non-serious (moderate/minor).No extended hospitalization.The contact force (cf) monitoring methods used were real time graph, dashboard, vector, and visitag.The coloring setting for visitag was tag index.Additional filter for visitag used was fot.The physician's assessment of the health hazard and its involvement with the product was causal in relationship with the product.The physician's opinions on the relationship between the event and the product that in the rvot, mapping was performed with the decanav catheter (d-curve) and the qdot micro catheter.No ablation was conducted.Considering the time when the blood pressure decrease was observed, and the qdot micro catheter had been placed in the rvot for only a short time, leading the physician to consider that the cardiac tamponade might have been caused by the decanav catheter.The physician regarded the decanav catheter as a safe catheter.However, the tip of the decanav catheter was unexpectedly stiff.Therefore, the decanav catheter might not be appropriate to be used for the tiny female patient who was elderly and small in anatomy.Transseptal puncture was performed with rf needle.Ngen available for procedure.No abnormalities observed prior/during use of the product.Additional information was received on 23-oct-2025.The outcome of the adverse event was improved.The patient did not require cardiac surgery.Additional information was received on 11-nov-2025.The patient was an elderly petite woman.No other relevant history/preexisting condition.No data for the procedural act before procedure.The procedural act during procedure was over 300seconds.The catheter was exchanged once from decanav to qdot.The sheath was not exchanged.Update was that a transseptal puncture was not performed.The decanav catheter was used to accessed inferior vena cava (ivc), right atrium (ra), right ventricle (rv), rvot, and mapping was performed; it was not inserted into the coronary sinus (cs).

• Brand Name: DECANAV
• 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: 23584513
• Report Number: 2029046-2025-03830
• Device Sequence Number: 18536377
• Product Code: DRF
• UDI-Device Identifier: 10846835008791
• UDI-Public: (01)10846835008791(17)260612(10)31678156M
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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 Expiration Date: 06/12/2026
• Device Catalogue Number: R7D282CT
• Device Lot Number: 31678156M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2025
• 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: CBL, 34 HYP/34 LEMO, BLU,10'.; EXTENSION CABLE.; QDOT MICRO, BI, TC, D-F.; UNKNOWN INTRACARDIAC ECHOGRAPHY SYSTEM.; UNKNOWN RF NEEDLE.; UNKNOWN SHEATH.; UNK_CARTO 3.; UNK_NGEN RF GENERATOR.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 41 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian