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

Catalog Number	D128211
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a pentaray nav catheter for which biosense webster¿s product analysis lab (pal) identified the transition in the tip between the electrodes was separated.Deflection issue.During the procedure, device was unable to deflect or relax completely.A second device was used to complete the procedure.There was no adverse event reported on the patient.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 05-mar-2026, observed the transition in the tip between the electrodes was separated.The event was originally considered non-reportable, however, bwi became aware of the transition in the tip between the electrodes was separated on 05-mar-2026 and have assessed this returned condition as reportable.
Additional Manufacturer Narrative
The device evaluation details.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation on 21-jan-2026.Visual inspection and deflection test of the returned device were performed following j&j medtech procedures.Visual analysis revealed that the transition in the tip between the electrodes was separated; however, adhesive residues were observed in the area, no manufacturing deficiencies were found.A deflection test was performed, and the curve was deflecting within specifications.No deflection issues were observed.Due to the condition on the tip, a manufacturing investigation had to be initiated.A manufacturing investigation was performed, and the records showed that the device passed all the necessary tests and inspections per process flow; additionally, no manufacturing deficiencies were observed, the failure mode was also replicated by applying excessive manipulation around the area; therefore, it was determined this issue is not manufacturing related.A manufacturing record evaluation was performed for the finished device lot number, and no internal actions 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 potential cause of the broken tip could be related to the handling/shipping after the procedure; however, this could not be conclusively determined.The broken tip issue is unrelated to the reported event.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the biosense webster inc.Analysis finding of the ¿the transition in the tip between the electrodes was separated¿.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿deflection issue¿.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).

• Brand Name: PENTARAY NAV
• 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: 24716677
• Report Number: 2029046-2026-01011
• Device Sequence Number: 5763696
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: (01)10846835012255(17)280707(10)31702873L
• 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): 03/27/2026

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: D128211
• Device Lot Number: 31702873L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2025
• 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