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

Catalog Number	D139401
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a bwi-sponsored clinical study a patient underwent an index cardiac ablation with a qdot micro catheter and experienced pleural effusion post-ablation.The issue was categorized as moderate and serious with prolonged hospitalization.The patient was originally admitted on (b)(6) 2025, had their procedure on (b)(6) 2025, and was discharged on (b)(6) 2025.It was determined that the event was not related to the qdot micro catheter or other devices used.Additionally, the relationship between the procedure itself and the event is that the effusion was a possibility but that its occurrence was unexpected/unanticipated.The patient was treated with the medication furosemide, and their issue was confirmed to be resolved by (b)(6) 2026.
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 reference number: (b)(4).
Additional Manufacturer Narrative
Per internal review on 20-feb-2026, it was determined that this event is not fda-reportable.There is no information to report as prior to the initial report's submission, bwi received information (on 13-feb-2026) that the effusion was not related to the products used in the procedure.This event was mistakenly reported and no further reports will be sent.Manufacturer 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: 24380596
• Report Number: 2029046-2026-00541
• Device Sequence Number: 10568018
• Product Code: OAE
• UDI-Device Identifier: 10846835017045
• UDI-Public: (01)10846835017045(11)250903(17)280902(10)31749719L
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: D139401
• Device Lot Number: 31749719L
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2025
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 125 KG