MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number	D160901
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with an octaray mapping catheter and during the operation, while the catheter was inside the patient¿s body, there was electrocardiogram (ecg) signal interference.The signal interference (noise) was observed on the intracardiac ecg channel, which was observed on the carto® only.The physician had an intact ecg signal available to monitor the patient¿s heart rhythm.A second device was used to complete the operation.There was no adverse event reported on the patient.This event was originally assessed as not mdr reportable.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection and electrical test of the returned device were performed.Visual inspection revealed that the shaft was broken in the mid-section with exposed wires.This finding is mdr reportable.
Additional Manufacturer Narrative
The device was returned to j&j medtech for evaluation.Following j&j medtech procedures, a visual inspection and electrical test of the returned device were performed.Visual inspection revealed that the shaft was broken in the mid-section with exposed wires; in addition, some electrical and magnetic wires were observed broken.The device was connected to the carto 3 system, and it was recognized and visualized; however, error 116 and black electrodes were observed.The handle of the device was dissected, and the electrical coils were measured, and an open circuit was found at the tip area.Due to error 116, the resistance of the sensors was measured, and an open circuit was found at the location where the shaft was found broken.A manufacturing record evaluation was performed for the finished batch number, and no internal actions were identified.The electrical issue reported by the customer was confirmed.The potential cause of the open circuit could not be determined.The broken shaft and magnetic sensor error are unrelated to the failure reported.The potential cause of the magnetic error could be related to the broken shaft.The potential cause of the broken shaft could be related to the handling of the device; however, this cannot be conclusively determined.The carto® 3 system instructions for use (ifu) contain the following information: ecg noise is typically generated as the result of improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify proper connection.It is recommended to turn off the notch filter for this verification.As part of johnson & johnson medtech's 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 ref.No: (b)(4).

• Brand Name: OCTARAY MAPPING CATHETER
• Common Device Name: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: 22983625
• Report Number: 2029046-2025-03028
• Device Sequence Number: 9430215
• Product Code: MTD
• UDI-Device Identifier: 10846835021141
• UDI-Public: (01)10846835021141(17)250709(10)31375605L
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K193237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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 Expiration Date: 07/09/2025
• Device Catalogue Number: D160901
• Device Lot Number: 31375605L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2024
• 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