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

Catalog Number	D139501
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	03/07/2025
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 number lot 31469393l and no internal action related to the complaint was found during the review.However, if the product is received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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 with qdot micro and the patient experienced cardiac tamponade that required pericardiocentesis and percutaneous cardiopulmonary support.In the atrial fibrillation second procedure, gap ablation for pulmonary vein isolation (pvi) and non-pulmonary vein (pv) ablation were performed.There was a recurrence in the left inferior pulmonary vein (lipv), and the lipv gap was ablated.Non-pv firing was also confirmed due to pharmacological stress and ablation for the anterior walls of left atrium (la) and right atrium (ra) was performed using the csi tag as indicators.Af was stopped and considered the end point.After the procedure, pericardial fluid was observed with ultrasound, and drainage was performed.The drainage was successfully completed.However, blood pressure subsequently dropped, and the patient was admitted to the intensive care unit (icu).The hospital stay was prolonged.Ablation was performed prior to the cardiac tamponade identified.Steam pop was not confirmed.No abnormalities were observed prior to or during use of the product.Septal puncture was performed with an rf needle.Additional information was received on 24-mar-2025.Patient condition worsened.The cardiopulmonary function has recovered, but the patient was still unconscious.The patient was on percutaneous cardiopulmonary support.One transseptal puncture site was performed during the procedure.
Additional Manufacturer Narrative
Additional information was received on 27-apr-2025: the current patient condition was worse, and the hospitalization period has been extended due to cardiopulmonary function returns but unconscious.The patient did not have open chest surgery.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: 21755009
• Report Number: 2029046-2025-01015
• Device Sequence Number: 20883092
• Product Code: OAE
• UDI-Device Identifier: 10846835016710
• UDI-Public: (01)10846835016710(11)241004(17)271003(10)31469393L
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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: D139501
• Device Lot Number: 31469393L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 04/27/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2024
• 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: NGEN PUMP, JAPAN CONFIGURATION; OCTA,LNG,48P,3-3-3-3-3,D-CURVE; RF NEEDLE; UNK_CARTO 3; UNK_NGEN RF GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Race: Asian