MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT MICRO¿ CATHETER; 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	06/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported after cardiac ablation procedure with a qdot micro¿ catheter, the patient experienced dropped blood pressure/cardiac tamponade treated with pericardial drainage and thoracotomy.The roof side ablation was started using qdot catheter from lpv (left pulmonary vein) isolation, and li (left inferior), carina, lspv (left superior pulmonary vein) were ablated.Then, at the timing of roof side ablation, blood pressure dropped to 70.So, confirmation was made as a precaution.The puncture of a coronary artery (lad) by mistake during pericardial drainage was considered.As the blood pressure was maintained, the procedure was continued, and simultaneous preparations for pericardial drainage were made.A thoracotomy was performed, and vital signs were stabilized.The physician¿s assessment on health hazard was severe.The physician¿s comment on the relationship between the event and the product was that the contact force was increasing during the catheter manipulation.Extension of hospitalization period was noted.Visitag coloring setting used was tag index, and additional filter for visitag used was fot (force over time).No abnormalities observed prior/during use of the product.There was no error code.The information received indicated that the outcome of the adverse event was improved.Delivered rf (radiofrequency) energy was used for each group of performed ablations.Prior to noting the ct ablation was performed.The patient required cardiac surgery.A ngen generator/pump was used.No error messages observed on biosense webster equipment during the procedure.
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 lot number 31566432l 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.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition.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
On 22-jul-2025, bwi received additional information indicating that the act (activated clotting time) was around 350 seconds.There was no evidence of steam pop.Section a4 was also updated with the patient's weight (60 kg).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¿ CATHETER
• 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: 22500690
• Report Number: 2029046-2025-02312
• Device Sequence Number: 12515908
• Product Code: OAE
• UDI-Device Identifier: 10846835016710
• UDI-Public: (01)10846835016710(11)250124(17)280123(10)31566432L
• 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): 08/13/2025

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: 31566432L
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2025
• 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 (FOR JAPAN).; NGEN RF GENERATOR, JAPAN.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian