MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV ECO 7FR, F, 2-6-2; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number	D128208
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection of the returned device was performed.Visual analysis revealed a separation on the tip-shaft transition.A manufacturing investigation was requested to define the root cause of the separation of the tip area.A manufacturing record evaluation was performed, and no internal action was found during the review.The broken tip reported by the customer was confirmed.The root cause of the separation of the tip with the shaft was the incorrect assembly of the polyimide into the tip.The instructions for use (ifu) contain the following information: do not immerse the handle or the cable connector in fluids; electrical performance could be affected.As part of the johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.An internal action was created to address the separation of the shaft and tip.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 and the pentaray catheter tip broke.Ther was no wires being exposed, nor lifted or sharp rings.There was no difficulty during insertion or removal of the catheter.The issue was approximately 5cm from the distal end of the catheter.There was no patient consequence.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 of the returned device was performed.Visual analysis revealed a separation on the tip-shaft transition.This finding is mdr reportable.

• Brand Name: PENTARAY NAV ECO 7FR, F, 2-6-2
• 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: 24471754
• Report Number: 2029046-2026-00666
• Device Sequence Number: 10277565
• Product Code: MTD
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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: D128208
• Device Lot Number: 31660851L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2025
• 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