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 when the doctor changed catheters to a pentaray, the doctor noticed some charring above the electrode.The settings are known from previous complaints on the subject of charring.The patient had no complications.The charring was between the tip electrode and electrode.No error messages were noted prior to the discovery.There were no temperature or flow issues either.The correct catheter settings had been selected.The generator parameters were: qmode+4s 16 90w ¿ temperaure target: 55°c temperature cut off: 65°c 5.The patient was anticoagulated with an activated clotting time (act) over 300, a value which was maintained throughout the case.The physician considered the amount of char to be excessive and to present a potential patient risk.There were no ablations that used for above 40g for extended periods of time--the physician aims for 5-15g.Heparanized normal saline was used for irrigation.No further details were provided.No patient consequences were reported.
Additional Manufacturer Narrative
On 12-feb-2026, 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 when the doctor changed catheters to a pentaray, the doctor noticed some charring above the electrode.The settings are known from previous complaints on the subject of charring.The patient had no complications.The charring was between the tip electrode and electrode.No error messages were noted prior to the discovery.There were no temperature or flow issues either.The correct catheter settings had been selected.The generator parameters were: qmode+4s 16 90w temperaure target: 55°c temperature cut off: 65°c 5.The patient was anticoagulated with an activated clotting time (act) over 300, a value which was maintained throughout the case.The physician considered the amount of char to be excessive and to present a potential patient risk.There were no ablations that used for above 40g for extended periods of time--the physician aims for 5-15g.Heparanized normal saline was used for irrigation.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection, irrigation and temperature and impedance test of the returned device were performed.Visual inspection revealed no damage or anomalies on the device.The device was connected to the generator and an ablation cycle was performed and the device was found working correctly.No temperature or impedance issues were observed.An irrigation test was performed, and the device was flushing correctly, no obstructed holes were observed.No irrigation issues were observed.A microscopical inspection revealed char residues in the pebax section close to the dome electrode.A manufacturing record evaluation was performed for the finished device (b)(6) number, and no non-conformances related to the reported complaint condition were identified.The char issue reported by the customer was confirmed.The potential cause of the char could be related to the usage of the device during the procedure; however, this can not be conclusively determined.The instructions for use (ifu) contain the following information: when rf (radiofrequency) 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 the johnson & johnson medtech quality process, 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: 23898516
• Report Number: 2029046-2025-04300
• Device Sequence Number: 10143821
• Product Code: OAE
• UDI-Device Identifier: 10846835025248
• UDI-Public: (01)10846835025248(11)250519(17)280518(10)31632082L
• 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
• Report Date (Section B): 03/06/2026

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: 31632082L
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2025
• 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 RF GENERATOR; PENTARAY CATHETER
• Patient Sex: Unknown