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	Aortic dissection (4870)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
After completing a premature ventricular contraction (pvc) ablation procedure with a qdot micro catheter, the patient experienced aortic dissection treated with surgery and prolonged hospitalization.The report indicated that the patient developed aortic dissection after pvc procedure, the approach to the left ventricle (lv) made via the aorta and ablation performed.After the lv mapping with optrell, the patient began complaining of lower back pain.The mapping was performed around the lv and the cusp area.While the physician was monitoring the patient, the patient fell asleep.Subsequently, the ablation took place at the upper part of the lv using qdot micro catheter.No ablation performed at the aorta.The patient left the room after the pvc terminated but developed the aortic dissection and transferred to the operation room.No issues with carto 3 system or the catheters, and no abnormal behavior observed when passing through the aorta.Additional information was received indicating the aortic dissection occurred within one hour after the procedure.The patient required extended hospitalization, however, the duration is unknown.The physician commented that the cause could not be identified.It did not appear to be related to carto products.The outcome of the adverse event was fully recovered (no residual effects).
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 ref.# (b)(4).
Additional Manufacturer Narrative
After completing a premature ventricular contraction (pvc) ablation procedure with a qdot micro catheter, the patient experienced aortic dissection treated with surgery and prolonged hospitalization.Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device lot number 31579590l and no non-conformances 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 22914027
• Report Number: 2029046-2025-02897
• Device Sequence Number: 9221366
• Product Code: OAE
• UDI-Device Identifier: 10846835016710
• UDI-Public: (01)10846835016710(11)250213(17)280212(10)31579590L
• 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

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: 31579590L
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2025
• 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: CARTO; NGEN PUMP, JAPAN CONFIGURATION; NGEN RF GENERATOR, JAPAN; OPTRELL, 48 ELECTRODES, D-F; SOUNDSTAR ECO SMS 8F CATHETER
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Race: Asian