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

Catalog Number	D139504
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/01/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
A patient received an index cardiac ablation procedure with a qdot micro on (b)(6) 2026.On (b)(6) 2026, patient experienced sudden death (adverse event #1) categorized as severe and serious defined by death.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 number lot 31765943l and no internal actions related to the complaint were 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.The manufacturer's ref.#: (b)(4).
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).
Event or Problem Description
A patient received an index cardiac ablation procedure with a qdot micro on (b)(6) 2026.On (b)(6) 2026, patient experienced sudden death (adverse event #1) categorized as severe and serious defined by death.Relationship to study device is not related and relationship to the index study procedure is not related.The outcome is death.Intervention was none.The clinical database reports that the type of mortality is unknown as the only information is that the patient suddenly died.
Additional Manufacturer Narrative
On 3-jun-2026, it was noticed an incorrect 510k number was reported under field g4.Pma/ 510(k) of the 3500a initial medwatch report.The field has now been corrected from "p210027" to "p210027_s000".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: 25382278
• Report Number: 3013300026-2026-01774
• Device Sequence Number: 18511288
• Product Code: OAD
• UDI-Device Identifier: 10846835016741
• UDI-Public: (01)10846835016741(11)251020(17)281019(10)31765943L
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P210027_S000
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: D139504
• Device Lot Number: 31765943L
• 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: 05/11/2026
• Supplement Date Received by Manufacturer: 06/03/2026; 06/14/2026
• Initial Report FDA Received Date: 06/03/2026
• Supplement Report FDA Received Date: 06/03/2026; 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2025
• 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: Death
• Patient Age: 74 YR
• Patient Sex: Male