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

Catalog Number	D139402
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial flutter right (r-afl) ablation with a qdot micro catheter and the patient experienced first degree heart block with dropped beats treated with pacemaker implant.It was reported that after the cavotricuspid isthmus (cti) ablation for atrial flutter, the patient experienced first degree heart block with some dropped beats.The patient arrived to the lab in incessant 200ms atrial flutter that terminated during radiofrequency (rf) ablation.The heart block was noticed on carto 3 system and ep recording system ekg's.The physician decided to implant a micra pacemaker into the ventricle.The patient was stable and still expected to be discharged the same day.The patient had comorbidities, including a recent heart tumor.The physician did not believe that biosense webster inc (bwi) products had anything to do with the patient's heart block.They did not know what the underlying rhythm was because of the incessant flutter.
Additional Manufacturer Narrative
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.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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 reference number: (b)(4).

• Brand Name: QDOT MICRO
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 22975773
• Report Number: 2029046-2025-03023
• Device Sequence Number: 13109233
• Product Code: OAD
• UDI-Device Identifier: 10846835017076
• UDI-Public: 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2025

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: D139402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 09/05/2025
• 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: 7FR DECAN,11P,F,2.4MMLE,282MM,; CARTO 3 SYSTEM; EP RECORDING SYSTEM; MICRA PACEMAKER; NGEN RF GENERATOR, US; STERILMED GE SOUNDSTAR CATHETER; UNK_CARTO VIZIGO SHEATH; UNK_OCTARAY NAV
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown