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

Catalog Number	D139401IL
Medical Device Problem Codes	Signal Artifact/Noise (1036); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection evaluation, electrical, temperature and impedance test of the returned device was performed following j&j medtech procedures.Visual inspection of the returned sample revealed a hole in the surface of the pebax.No other damages were found.An electrical test was performed and the results were found within specifications.Afterward, a temperature and impedance test was performed.No impedance issues were detected; however, no temperature values were displayed due to an open circuit in the tip area.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The hole observed in the pebax section could be related to the noise and impedance issue reported by the customer; therefore, the customer complaint was confirmed.The temperature issue was not related to the reported event.The potential cause of the pebax damage could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.The potential cause of the open circuit could not be determined.The instructions for use (ifu) contain the following recommendations: -do not scrub or twist the distal tip electrode during cleaning.-ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.-if the generator does not display temperature, verify that the cables from the catheter to the carto¿ system patient interface unit (piu) and the cable from the carto¿ system patient interface unit (piu) to the generator are properly connected.If temperature still is not displayed, there may be a malfunction in the temperature sensing system that must be corrected prior to applying rf power.As part of the johnson & johnson medtech quality process, all devices are manufactured, inspected, and released 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 that a patient underwent an atrial fibrillation (afib) ablation procedure with a qdot micro for which biosense webster¿s product analysis lab (pal) identified a hole on the surface of the pebax.It was initially reported by the customer that during the operation, signal interference (noise) was observed on intracardiac (ic) channels and severe interference was observed on the first electrodes.There was no impedance value reading from the device.A second device was used to complete the operation.There was no adverse event reported on patient.Additional "information" was received indicating the issue was observed only on intracardiac (ic) channels on the carto 3 system only.The catheter was inside the patient¿s body at the time of incident.The physician did have other intact ecg signal available to monitor the patient¿s heart rhythm.The customer's reported noise interference is not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On (b)(6) 2025, the bwi pal revealed that a visual inspection of the returned device found a hole in the surface of the pebax.The finding was reviewed and assessed as an mdr reportable malfunction since the integrity of the device has been compromised.

• 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: 23835583
• Report Number: 2029046-2025-04213
• Device Sequence Number: 17413523
• Product Code: OAE
• UDI-Device Identifier: 10846835017045
• UDI-Public: (01)10846835017045(11)250302(17)280301(10)31572748L
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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

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: D139401IL
• Device Lot Number: 31572748L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2025
• 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: UNKNOWN ECG MONITORING SYSTEM; UNK_CARTO 3
• Patient Sex: Unknown