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

Catalog Number	D128210
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product investigation was completed.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection evaluation and deflection test of the returned device was performed following j&j medtech procedures.Visual inspection of the returned device revealed that the tip was found broken and stress marks were observed in the broken area.The t-bar and internal components were exposed.A deflection test was performed, and the deflection curve was not within specifications.A manufacturing record evaluation was performed for the finished device 31566551l number, and no internal actions related to the reported complaint condition were identified.The tip condition could be related to the deflection issue reported by the customer; therefore, the customer complaint was confirmed.The potential cause of the broken tip could be related tot he excessive force or manipulation of the device during the procedure; however, this can not be conclusively determined.The instructions for use (ifu) contain the following information: adjust the radius of curvature as necessary by manipulating the thumb knob.Pushing the thumb knob forward causes the catheter tip to curve; pulling the thumb knob back straightens the catheter tip.As part of the johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through j&j medtech quality system.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation - paroxysmal ablation procedure with a pentaray nav high-density mapping eco catheter and post procedure the bwi product analysis lab identified that the tip was broken and there were stress marks in the broken area.During the procedure, the catheter was unable to deflect or relax completely.A second device was used to complete the operation.There was no adverse event reported on patient.

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO 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: 22462332
• Report Number: 2029046-2025-02246
• Device Sequence Number: 8550967
• Product Code: MTD
• UDI-Device Identifier: 10846835012248
• UDI-Public: (01)10846835012248(17)280204(10)31566551L
• 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): 07/09/2025

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: 31566551L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2025
• 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