MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DECANAV; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number	R7F282CT
Medical Device Problem Codes	Signal Artifact/Noise (1036); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a decanav and a and a signal noise occurred on all ic channels on all systems.It was reported that during the operation, the signal interference (noise) was observed on intracardiac (ic) channels.A second device was used to complete the operation.There was no adverse event reported on patient.Signal interference (noise) observed on the ic channels on both the carto 3 system and the recording system.The physician did not have any intact ecg signal available to monitor patient heart rhythm.This issue occurred while the affected catheter was inside the patient¿s body.
Additional Manufacturer Narrative
Device investigation details: a picture was received for evaluation following johnson & johnson medtech's procedures.According to the picture provided by the customer, a signal noise was observed on carto 3 screen.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly, and any action will be taken if necessary.Note: h6.Investigation findings code of ¿appropriate term/code not available (c22)¿ used to represent the photo analysis results.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).
Additional Manufacturer Narrative
On 15-aug-2025, additional information was received indicating the physician did have another system available with intact body surface (bs) signals to monitor the patient¿s heart rhythm.As such, this event has been reassessed as a non-reportable product issue.This event is no longer considered to be mdr reportable.Manufacturer's ref.# (b)(4).

• Brand Name: DECANAV
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 22790469
• Report Number: 2029046-2025-02672
• Device Sequence Number: 8789144
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: (01)10846835008807(17)260429(10)31637292M
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K080425
• 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

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 Expiration Date: 04/29/2026
• Device Catalogue Number: R7F282CT
• Device Lot Number: 31637292M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2025
• 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: CARTO 3 SYSTEM; UNKNOWN RECORDING SYSTEM
• Patient Sex: Unknown