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	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a pentaray nav catheter and observed an occlusion/no irrigation issue (device was used in the patient).Occlusion/ no irrigation.During the procedure, device (including port, luer hub) was not irrigating.A second device was used to complete the procedure.There was no adverse event reported on the patient.Additional information was received on 10-feb-2026.The device was used in the patient.Smartablate pump was used.No error was noted from the irrigation pump.At first, the patient was able to perform normal perfusion and then, took out the body for placement.When used again, it was found that the perfusion hole was blocked.Correct catheter settings were selected on the generator.No issues with flow rate change at the start of irrigation.The occlusion/no irrigation issue was originally considered non-reportable, however, bwi became aware on 10-feb-2026 that the device was used in the patient and have reassessed the event as reportable.The awareness date for this record is 10-feb-2026.
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).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a pentaray nav catheter and observed an occlusion/no irrigation issue (device was used in the patient).The device evaluation details.The device was returned to johnson & johnson medtech (j&j) for evaluation on 13-apr-2026.Visual inspection and irrigation test of the returned device were performed following j&j procedures.Visual analysis revealed no damage or anomalies on the device.An irrigation test was performed and the catheter failed the test since no flow was observed.Afterwards, an aluminum wire was introduced in the luer hub and the wire got stuck at the tip area.The tip was dissected and the irrigation tube was inspected and it was found the irrigation tube folded into a "z" shape in the transition between the tip to the sheath.This failure mode was identified as manufacturing related.A manufacturing record evaluation was performed and no internal actions related to the reported complaint condition were identified.The irrigation issue reported by the customer was confirmed.The root cause of the folded irrigation tubing is traced to the manufacturing process.The instruction for use (ifu) contains the following warning and precautions: 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.This product issue will be addressed through j&j's quality system.Explanation of codes: -investigation findings: manufacturing process problem identified (c16) / investigation conclusions: cause traced to manufacturing (d03)/ component code: hose (g04069) were selected as related to the customer¿s reported ¿irrigation¿ issue.In addition, biosense webster inc.Analysis finding of the ¿manufacturing process¿ related.-investigation findings: operational problem identified (c13) / investigation conclusions: cause traced to manufacturing (d03)/ component code: hose (g04069) were selected as related to the customer¿s reported ¿irrigation¿ issue.In addition, biosense webster inc.Analysis finding of the ¿the irrigation tube folded into a "z" shape in the transition between the tip to the sheath¿.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: 24537959
• Report Number: 2029046-2026-00744
• Device Sequence Number: 8895084
• 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): 05/04/2026

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: 31753660L
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2025
• 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