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

Catalog Number	D128211
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 an atrial fibrillation (afib) procedure with a pentaray nav catheter and a crack issue was observed.The catheter was leaking at the base before the electrodes along the shaft of the catheter.Found a visible crack where the leak was coming from.They had not inserted the catheter into the body when this was discovered.The issue was resolved when the catheter was replaced.The catheter was brand new and not reprocessed.There was no patient consequence reported.Additional information was received.The catheter had not been inserted into a sheath or the body when the leak was found.They were testing the flushing before advancing into the body.The leak was right below the shaft electrodes.The device was not pre-shaped.The catheter leak issue was assessed as non mdr reportable.Catheter leak was highly detectable by the physician.The most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The crack issue was assessed as mdr reportable.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 25-feb-2026.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a pentaray nav catheter.The catheter was leaking at the base before the electrodes along the shaft of the catheter.Found a visible crack where the leak was coming from.The device evaluation was completed on 03-mar-2026.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection and functional tests of the returned device were performed.Visual inspection revealed no damage or anomalies on the device.Further analysis under image magnification was performed on shaft and tip transitions; however, no anomalies were detected.The device was connected for irrigation and no water leakage issues were observed.A manufacturing record evaluation was performed for the finished device number: 31720265l, and no internal actions related to the reported complaint were identified.The device detachment and leakage reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the use of the device that may have affected its performance.The instructions for use (ifu) contain the following information: flush the catheter with heparinized saline prior to insertion into the body.Always follow standard practices of using a continuous drip of anticoagulant fluid under pressure through the proximal luer connector when the device is in the body.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
• 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: 24397108
• Report Number: 2029046-2026-00568
• Device Sequence Number: 15533285
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: (01)10846835012255(17)280728(10)31720265L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2026

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: 31720265L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 02/25/2026; 03/03/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/02/2026; 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2025
• 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