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

Catalog Number	D139505
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	02/10/2026
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a qdot micro and experienced cardiac failure.The report indicated that at the end of the afib case, the patient's statistics (stats) were low, along with low blood pressure.The patient was diagnosed with acute biventricular failure at the end of the case.The acute biventricular failure was confirmed using transesophageal echocardiogram (tee).The patient was confirmed to have no pericardial effusion with the tee.The patient was moved to intensive care unit (icu).The last known patient status was stable.Prior to ablation procedure, at the beginning of the afib case with rapid ventricular response (rvr), the patient was cardioverted and the procedure was completed with a qdot micro catheter.The physician¿s opinion on the cause of this adverse event was that it was due to the patient¿s afib with rvr and cardioversion and did not think that it had anything to do with a biosense webster inc.(bwi) product that was used.

• 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: 24551124
• Report Number: 2029046-2026-00758
• Device Sequence Number: 15824083
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: (01)10846835016758(11)251001(17)280930(10)31769176L
• 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
• Report Date (Section B): 03/09/2026

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: D139505
• Device Lot Number: 31769176L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2025
• 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 3 SYSTEM.; NGEN PUMP, US CONFIGURATION.; NGEN RF GENERATOR, US.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 105 KG