MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT MICRO, BI, TC, D-D; 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	03/07/2025
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 31469402l 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.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 and the patient experienced cardiac tamponade that required pericardiocentesis.After the procedure, approximately 40 minutes after the procedure was completed, the patient's blood pressure decreased.Upon examination of the pericardial fluid, a diagnosis of cardiac tamponade was made.Drainage was performed.The patient was under observation in the ward.Patient did not require extended hospitalization.The plan was to observe the patient through outpatient visits, and the procedure will be performed again.The physician's opinion on the cause of the adverse event is unknown.In this case, the only difference from usual was the use of a sheath from medikit instead of the typically used sl0 sheath.The wire took a considerable amount of time to emerge from the tip of the sheath, and transseptal puncture was performed about three times.No abnormalities were observed prior to or during use of the product.No error messages observed on biosense webster equipment during the procedure.No evidence of steam pop.No ablation was performed prior to noting the pericardial effusion.
Additional Manufacturer Narrative
Additional information was received which indicated that ablation was performed.The procedure was conducted as usual, and blood pressure did not decrease during the surgery.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, BI, TC, D-D
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21734838
• Report Number: 2029046-2025-00989
• Device Sequence Number: 3981480
• Product Code: OAE
• UDI-Device Identifier: 10846835016710
• UDI-Public: (01)10846835016710(17)271007(10)31469402L
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

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: 31469402L
• 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: 03/07/2025
• Supplement Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• 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; MEDIKIT SHEATH; OCTA,LNG,48P,3-3-3-3-3,D-CURVE; RADIOFREQUENCY NEEDLE; SMARTABLATE GENERATOR; SMARTABLATE PUMP; SOUNDSTAR ECO GE 8F CATHETER
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 43 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian