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

Catalog Number	D128211
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) paroxysmal ablation procedure with a pentaray nav and a plastic string attached to one of the electrodes was noticed right out of the package.The catheter was replaced, and the problem was resolved.The case continued.A replacement catheter was requested.No adverse patient consequence was reported.Additional information was received and it indicated that the foreign object is clear plastic and embedded on device with no movement.The device was used on the patient before the item was noticed.Multiple attempts were made to clarify the additional information received as contradictory to what was initially reported.No response has been received at the time of reporting.Ablation system in use: ngen¿ generator.
Additional Manufacturer Narrative
The biosense webster, inc.Product analysis lab received the device for evaluation.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.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).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) paroxysmal ablation procedure with a pentaray nav and a plastic string attached to one of the electrodes was noticed right out of the package.Device investigation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.A visual inspection of the returned device was performed in accordance with j&j medtech procedures.Visual analysis revealed that spline b was bent.Additionally, electrode eighteenth was squashed; however, no foreign material was found attached to the electrodes.The electrode and spline damage suggests usage of the device and could be related to the issue reported.Two pictures uploaded from the decontamination site show a translucent string of foreign material attached to the splines of the device.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The foreign material issue was confirmed based on the pictures from the decontamination site.The electrode and spline damage could be the result of the interaction of the device with another device during the procedure, thus causing the foreign material issue.However, this could not be conclusively determined.The potential cause of the foreign material could not be established conclusively as it was not returned for the investigation.The instructions for use contain the following recommendations: do not introduce the catheter into a guiding sheath with the catheter¿s distal spines folded backward toward the handle.Collapse the spines together using the insertion tube prior to insertion.The catheter is recommended for use with an 8 f guiding sheath because the distal spines may be damaged if used with a sheath that is not compatible.Do not use the catheter in conjunction with transseptal sheaths featuring side holes larger than 1.25 mm in diameter.Do not use excessive force to advance or withdraw the catheter through the guiding sheath when resistance is encountered.As part of the 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: 24398448
• Report Number: 2029046-2026-00574
• Device Sequence Number: 13290290
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: (01)10846835012255(17)280925(10)31775591L
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: 31775591L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2025
• 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