MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT MICRO; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number	D139402
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Cardiac Tamponade (2226); Heart Block (4444)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Note: for field d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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
During an atrial fibrillation and atrial tachycardia ablation procedure with a qdot micro catheter and the patient experienced heart block and cardiac tamponade requiring pericardiocentesis, pacemaker implantation, chest compression and epinephrine.It was reported that during the atrial tachycardia portion of the procedure with a qdot micro catheter, heart block and a cardiac tamponade were noticed in the patient.While ablating nearby the coronary sinus (cs) ostium for the atrial tachycardia, the patient went into heart block.The physician removed the qdot micro catheter from the patient, leaving just the reprocessed innovative health soundstar catheter in the body.They had mapped with an octaray catheter earlier in the procedure, but the octaray catheter was no longer in the body at this point.The physician decided to implant a pacemaker in the patient.During the pacemaker implant procedure, there were "complications and issues" noticed with the patient but could not confirm any additional details regarding the complications or issues.It was noticed that there was a cardiac tamponade in the patient.The medical intervention provided was a pericardiocentesis, and a quantity of 750 of fluid was removed from the patient.Unable to confirm the unit of measurement for the fluid removed.At some point, after the pericardiocentesis was performed, a code was called for the patient.They administered a round of chest compressions as well as epinephrine to the patient.The patient is in stable condition.Multiple attempts have been made to gain clarification and additional information about this event with no response.Should any new information be obtained it will be assessed and processed accordingly.

• 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: 24011847
• Report Number: 2029046-2026-00065
• Device Sequence Number: 9405761
• Product Code: OAE
• UDI-Device Identifier: 10846835017076
• UDI-Public: (01)10846835017076
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: D139402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 RF GENERATOR, US; SOUNDSTAR CATH REPROCES BY INNOVATIVE HEALTH; UNK_OCTARAY NAV
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown