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

Catalog Number	D128211
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
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 ablation procedure with a pentaray nav catheter and during the procedure the device (including port, luer hub) was not irrigating.The device had already been used on the patient.Syringe extracorporeal aspiration was attempted to no avail.The correct catheter settings were selected o the generator.There were no flow rate change issues at the start of ablation.A second device was used to complete the operation.There was no adverse event reported on patient.
Additional Manufacturer Narrative
On 1-apr-2026, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an atrial fibrillation ablation procedure with a pentaray nav catheter and during the procedure the device (including port, luer hub) was not irrigating.The device had already been used on the patient.Syringe extracorporeal aspiration was attempted to no avail.The correct catheter settings were selected o the generator.There were no flow rate change issues at the start of ablation.A second device was used to complete the operation.There was no adverse event reported on patient.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Visual inspection and irrigation test of the returned device were performed following j&j medtech procedures.Visual analysis revealed that the shaft was bent.An irrigation test was performed, and the catheter failed the test since the irrigation tube was found bent inside the shaft at the same place that the shaft was bent.A manufacturing record evaluation was performed for the finished device number lot 31780106l and no internal action related to the complaint was found during the review.The irrigation issue reported by the customer was confirmed due to the bent irrigation tube.The potential cause of the bent of the irrigation tube and shaft could be related to the manipulation of the device during or after the procedure, however, this could not be conclusively determined.The instructions for use contain the following recommendations: flush the catheter with heparinized normal saline prior to insertion into the body and ensure that saline flows through the distal end of the irrigation lumen.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: 24609264
• Report Number: 2029046-2026-00735
• Device Sequence Number: 9678030
• Product Code: MTD
• 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,Followup
• Report Date (Section B): 04/24/2026

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: 31780106L
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NGEN GENERATOR.; UNK PUMP.
• Patient Sex: Unknown