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	08/19/2025
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 ref.# (b)(4).
Event or Problem Description
A patient underwent a cardiac ablation procedure with a qdot micro catheter and the patient suffered a cardiac tamponade treated with drainage and the patient recovered.The report indicated that in the ward, immediately after the procedure (1 hour), it was confirmed via intracardiac echo (ice) catheter that there was no pericardial effusion.However, drainage was performed, and the patient recovered.Cardiac tamponade was noted.There was no prolongation of hospital stay.Contact force (cf) monitoring method included vector.Coloring setting used was visitag was tag index.Additional filter for visitag was force over time (fot).The physician's opinions on the relationship between the event and the product was that there is a possibility that the qdot micro catheter made strong contact with the atrium/ heart wall; it is possible that it has been strongly hit by the catheter, not cauterized, but this was not during ablation.It is not considered to be product related.No abnormalities were observed prior/during use of the product.The outcome of the adverse event was reported as fully recovered (no residual effects).Prior to noting the cardiac tamponade, ablation had already been performed.No evidence of steam pop.The patient did not require cardiac surgery.No issues with flow rate change at the start of ablation.No error messages observed on biosense webster equipment during the procedure.
Additional Manufacturer Narrative
On 9-sep-2025, additional information was received indicating the transseptal puncture was performed with rf needle by japan lifeline (jll).The flow setting for irrigation catheter were 35w: 4ml, 50w: 15ml.The correct catheter settings were selected on the generator.The visitag module parameters for stability used were range: stability+, time: 3sec, force over time (fot): 25%, and tag size: 4mm.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
A patient underwent a cardiac ablation procedure with a qdot micro catheter and the patient suffered a cardiac tamponade treated with drainage and the patient recovered.Device evaluation 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 31588989l and no internal action 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: 23006588
• Report Number: 2029046-2025-03059
• Device Sequence Number: 10502353
• Product Code: OAE
• UDI-Device Identifier: 10846835016710
• UDI-Public: (01)10846835016710(17)280220(10)31588989L
• 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,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: 31588989L
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 09/09/2025; 11/07/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/02/2025; 11/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2025
• 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, JAPAN CONFIGURATION.; NGEN RF GENERATOR, JAPAN.; RF NEEDLE BY JAPAN LIFE LINE.; UNKNOWN INTRACARDIAC ECHO CATHETER.; UNK_NGEN PUMP.; UNK_NGEN RF GENERATOR.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian