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	Cardiac Tamponade (2226)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device number lot 31749930l 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.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition.If the product is received at a later date, the investigation will be updated as applicable.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 a cardiac ablation procedure with a qdot micro catheter and suffered a cardiac tamponade treated with drainage.Required prolonged hospitalization.The report indicated that after the procedure with a qdot catheter the patient experienced blood pressure decrease.The body surface echocardiography confirmed intracardiac findings consistent with cardiac tamponade (at the end of carto3 use).Approximately 5 hours after the start of the procedure.Chest drainage was performed and blood pressure and other vital signs recovered.No extension of hospitalization.The visitag coloring setting was tag index.The information received indicated that the event was cardiac tamponade.The vital signs stabilized in the catheterization room and the patient condition is improving in the ward.The physician¿s assessment on health hazard was not serious (moderate/mild).The patient required extension of hospitalization.The contact force (cf) monitoring methods used were real time graph, dashboard, vector, and visitag.The visitag additional filter used was target temp.No abnormalities observed prior/during use of the product use.The outcome of the adverse event was improved.Prior to noting the cardiac tamponade ablation was performed.The patient did not require cardiac surgery.No error messages were observed on biosense webster equipment during the procedure.
Additional Manufacturer Narrative
Additional information was received on (b)(6) 2026.After checking the presence of pulmonary vein (pv) potentials in the left atrium (la), blood pressure decrease was noted when the mapping catheter was being withdrawn back into the right atrium (ra).The event may have occurred at that time.The outcome of the adverse event was fully recovered (no residual effects).The patient has been discharged from the hospital on (b)(6) 2026.Transseptal puncture performed with a nrg rf transseptal needle.No evidence of a steam pop.The flow setting was pre: 2 seconds; post: 4 seconds.The correct catheter settings were selected on the generator.There were no issues with flow rate change at the start of ablation.In addition, the product information was provided for the concomitant generator and pump.Therefore, updated d10.Concomitant medical products and therapy dates section.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's 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: 24490400
• Report Number: 2029046-2026-00690
• Device Sequence Number: 10685138
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: (01)10846835016758(11)250911(17)280910(10)31749930L
• 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
• Report Date (Section B): 03/26/2026

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: 31749930L
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2025
• 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: 7FR,DEF,15MM DIA., CCW,LASSO; NGEN PUMP, JAPAN CONFIGURATION; NGEN RF GENERATOR, JAPAN; OCTA,LNG,48P,3-3-3-3-3,D-CURVE; SOUNDSTAR ECO SMS 8F CATHETER; UNK_NGEN PUMP; UNK_NGEN RF GENERATOR; UNK_VISITAG SURPOINT¿ EPU
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 49 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian