MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT MICRO; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number	D139402
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) cardiac ablation procedure with a qdot micro catheter and the patient experienced pericardial effusion (pe) treated with pericardiocentesis which required extended hospitalization.The report indicated that there was a pericardial effusion reported during an afib procedure with qdot catheter.Post procedure, there was a drop in the patients¿ blood pressure, the physician confirmed via intracardiac echocardiography (ice) that there was a pericardial effusion present.Pericardiocentesis was performed and about 200ccs of fluid was removed.The drainage tube was left in place, and the patient was taken to intensive care unit (icu) for overnight observation, as per normal procedure.The patient was stable.The physician normally only does one transseptal puncture, but they lost the first transseptal access and a second transseptal puncture was performed.There was a slight drop in blood pressure after the first transseptal puncture, but the physician confirmed there was no effusion present and the procedure continued.They think the effusion occurred during the second transseptal puncture.The ablation catheter is available for return.Additional information received indicated that the outcome of the adverse event was fully recovered.The patient required extended hospitalization because of recovery and expected to be discharged today or tomorrow.This would be a 2¿3-day extension of normal hospitalization.The number of performed ablations was 17, with radiofrequency (rf) energy in qmode, only in pulmonary vein isolation (pvi) and carina.No ablations were performed outside the pulmonary veins.An ngen generator was used for the procedure.The activated clotting time (act) before the procedure was normal levels under 200.The act during the procedure was greater than 300.The transeptal puncture was completed and access lost.A second transeptal access was obtained.No effusion noted.The procedure continued with sl1 exchange for vizigo.Octaray was inserted to map, then exchanged for qdot catheter.Post ablation qdot was exchanged for octaray for post ablation voltage map.That is when effusion was noted.The transseptal puncture performed was brk xs 71 via sl1.Prior to noting the pe, ablation was performed.No evidence of steam pop.The flow setting was qmode.The patient did not require cardiac surgery.The correct catheter settings were selected on the generator.There were no issues with flow rate change at the start of ablation.No error messages were observed on biosense webster equipment during the procedure.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) cardiac ablation procedure with a qdot micro catheter and the patient experienced pericardial effusion (pe) treated with pericardiocentesis which required extended hospitalization.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 an ablation cycle was performed, no force, magnetic, noise, temperature or impedance 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 navigation system, careful catheter manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade.Catheter advancement should be done under direct imaging guidance.Do not use excessive force to advance or withdraw the catheter when resistance is encountered.The firmness of the braided tip dictates that care must be taken to prevent perforation of the heart.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: QDOT MICRO
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: 24260118
• Report Number: 2029046-2026-00382
• Device Sequence Number: 18554066
• Product Code: OAE
• UDI-Device Identifier: 10846835017076
• UDI-Public: (01)10846835017076(11)250625(17)280624(10)31657040L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P210027
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: D139402
• Device Lot Number: 31657040L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• 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: BRK XS 71 NEEDLE.; UNK_NGEN RF GENERATOR.; UNK_OCTARAY NAV.; UNK_SOUNDSTAR.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White