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

Catalog Number	D139402
Medical Device Problem Codes	Coagulation in Device or Device Ingredient (1096); Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 procedure with a qdot micro¿ catheter and the doctor noticed some charring above the electrode.The char was located above the electrode between the tip electrode and electrode 2 at the plastic ring separating the electrodes.The system did not present any error messages or product problem.There were no issues noted with the temperature or flow of the catheter.The correct catheter settings were selected.The generator parameters were as follows: qmode+ ¿ 90w ¿ temperature target: 55°c ¿ temperature cut off: 65°c.The act (activated clotting time) was above 300 and maintained throughout the case.Heparinized normal saline was used for irrigation.The physician determined that the charring could present an increased risk to the patient.However, no patient consequences were reported.
Additional Manufacturer Narrative
On 17-oct-2025, the product investigation was completed as the complaint device was not returned.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 31579026l 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 29-dec-2025, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent a cardiac ablation procedure with a qdot micro¿ catheter and the doctor noticed some charring above the electrode.The char was located above the electrode between the tip electrode and electrode 2 at the plastic ring separating the electrodes.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.Visual inspection, microscopic examination, irrigation, temperature, and impedance test of the returned device were performed following j&j procedures.Visual analysis reveled that no char, thrombus, or clot residues were identified.Then, a microscopic examination was performed and the irrigation holes were clean.A temperature and impedance test was performed, and no issues were observed.Finally, an irrigation test was performed, and the device was flushing correctly, no obstructed holes were observed.No irrigation issues were observed.A manufacturing record evaluation was performed for the finished device lot number 31579026l and no internal action related to the complaint was found during the review.The char issue reported by the customer was not confirmed.Other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instruction for use (ifu) contains the following warnings and precautions: monitor the catheter tip temperature response throughout the procedure to ensure adequate irrigation.If temperature increases very rapidly during rf application, power delivery should be interrupted.The irrigation system must be rechecked prior to restarting rf (radiofrequency) application.Note: the displayed temperature represents the temperature of the electrode only, not the temperature of the tissue.When rf energy is interrupted for either a temperature or an impedance rise (the set limit is exceeded), the catheter should be removed, and the tip should be inspected for char/coagulum that may be present on the tip.If present, do not continue the procedure with the same catheter and replace the catheter.If no char/coagulum is present, flush the tip to ensure the irrigation holes are not plugged prior to reinsertion of the catheter inside the patient body.As part of johnson & johnson medtech's quality, all devices are manufactured, inspected, and released to approved specifications.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: 22797185
• Report Number: 2029046-2025-02679
• Device Sequence Number: 12828200
• Product Code: OAE
• UDI-Device Identifier: 10846835017076
• UDI-Public: (01)10846835017076(11)250304(17)280303(10)31579026L
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 01/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: D139402
• Device Lot Number: 31579026L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 10/17/2025; 12/29/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 11/06/2025; 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2025
• 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: NGEN PUMP; UNK_NGEN RF GENERATOR
• Patient Sex: Unknown