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

Catalog Number	D128210
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a pentaray nav high-density mapping catheter and post procedure the bwi product analysis lab identified that the device tip was fully separated.During the procedure, the magnetic sensor issue/error was displayed.A second device was used to complete the operation.There was no adverse event reported on patient.
Additional Manufacturer Narrative
The product investigation was completed.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.A visual inspection and magnetic sensor functionality test of the returned device were performed following j&j medtech procedures.Visual analysis revealed that the tip of the device was separated.A magnetic sensor functionality test was performed, and the device was visualized and recognized correctly; no magnetic issues were observed.A microscopic inspection was performed on the area and adhesive residues were found, no manufacturing deficiencies were observed.A manufacturing record evaluation was performed for the finished device 31571205l, and no internal action was found during the review.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The tip separation issue could be related to the handling/shipping of the device after the procedure; however, this could not be established conclusively.The instructions for use contain (ifu) the following recommendations: the magnetic sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.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 reference number: (b)(4).

• Brand Name: PENTARAY NAV HIGH-DENSITY 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: 22874539
• Report Number: 2029046-2025-02774
• Device Sequence Number: 5689795
• Product Code: MTD
• UDI-Device Identifier: 10846835012248
• UDI-Public: (01)10846835012248(17)280212(10)31571205L
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123837
• 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
• Report Date (Section B): 08/22/2025

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: D128210
• Device Lot Number: 31571205L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2025
• 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
• Patient Sex: Unknown