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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	06/17/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
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 lot number 31560023l 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 ref.# (b)(4).
Event or Problem Description
It was reported a patient underwent a cardiac ablation procedure with a vizigo and a qdot micro catheter.The patient experienced accumulation of blood in the abdomen treated with blood transfusion for the bleed and later the patient experienced cardiac tamponade and expired two days after the procedure.It was initially reported that after the procedure, an accumulation of blood in the abdomen was found when the drape was removed.Intracardiac was checked by echocardiography, and no pericardial effusion was confirmed.After the patient left the procedure room a blood transfusion was performed.The physician's opinion was that there was an issue with some aspect of the workflow during the puncture before the use of bwi products.On (b)(6) 2025, additional information was received indicating that in addition to the abdominal blood accumulation observed immediately after the procedure, cardiac tamponade was confirmed at a later date and the patient passed away in the hospital 2 days after the index procedure.The details were unclear, but the physician suspected that the issue occurred during the puncture prior to the use of bwi devices.The physician's assessment of the health hazard was serious.The physician's opinions on the relationship between the event and the product was immediately after the procedure, intracardiac was checked by echocardiography, no pericardial effusion was confirmed.No abnormalities were observed with the product prior to or during use of the products.
Additional Manufacturer Narrative
On 22-jul-2025, additional information about the patient and event were received.It was reported the procedural activated clotting time (act) was 300 seconds.Several catheter exchanges occurred during the procedure.The energy delivered was radiofrequency (rf).There was no evidence of steam pop.Transseptal puncture was performed with unknown needle.The vizigo sheath was not used for transseptal access.No error messages observed on biosense webster equipment during the procedure.The correct catheter settings were selected on the generator.There were no issues with flow rate changes at the beginning of the procedure.Force visualization features used included vector, realtime graph.Visitag module parameters for stability were range: 3mm, time: 3sec, force over time (fot): 25%, tag size: 2mm.No additional filters wre used.Color options used were tag index.The physician's opinion on the cause of death was cardiac tamponade or hemorrhagic shock before the cardiac tamponade was confirmed.It was reported that during the procedure, a decrease in blood pressure was observed; however, at that time, no pericardial effusion was confirmed on ultrasound.After the procedure, when the covering cloth was removed, a subcutaneous blood accumulation in the abdomen was noted, and drainage and transfusion were performed.The physician suspected that vascular dissection during the puncture may have been the cause.On the morning of 2 days after the procedure, cardiac tamponade was found, and the patient subsequently died.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: 22452497
• Report Number: 2029046-2025-02221
• Device Sequence Number: 8118652
• Product Code: OAE
• UDI-Device Identifier: 10846835016710
• UDI-Public: (01)10846835016710(17)280123(10)31560023L
• 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

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: 31560023L
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 08/14/2025
• 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: 8.5F SHEATH, VIZ SMCURVE,SHORT; OCTA,LNG,48P,3-3-3-3-3,D-CURVE; SOUNDSTAR ECO SMS 8F CATHETER; UNKNOWN ECHOGRAPHY SYSTEM; UNKNOWN TRANSSEPTAL NEEDLE; UNK_CARTO 3; UNK_NGEN RF GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian