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

Catalog Number	D128208
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation details.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation on 08-oct-2025.Following j&j medtech procedures, a visual inspection and irrigation test of the returned device were performed.Visual inspection revealed no damage or anomalies on the device.An irrigation test was performed, and the catheter failed the test due to the irrigation tube was found folded at the tip area.A manufacturing record evaluation was performed for the finished device lot number and no internal action was found during the review.The irrigation issue reported by the customer was confirmed.The root cause of the irrigation tube folded is traced to manufacturing process.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.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¿ 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 ¿irrigation tube was found folded at the tip area¿.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 (afib) procedure with pentaray nav catheter and an irrigation issue occurred (device used on patient).Initially reported that they could not "flush" the pentaray nav catheter prior to advancing it into the body.It would not flush regardless of the high force used.The catheter was replaced and the issue resolved.It was a brand new catheter.The procedure continued with no further issues.A smartablate® generator was in use.Additional information was received on 23-sep-2025.The suspected device for the reported flow / irrigation issue was the catheter.The device was used on the patient.It initially flushed and was used.It was exchanged for an ablation catheter and before reinserting the pentaray, it could not be flushed.Tried to flush with pressure bag and manually with syringe.No success.This irrigation issue was originally considered non-reportable, however, bwi became aware on 23-sep-2025 that the device was used on the patient and have reassessed the event as reportable.The awareness date for this record is 23-sep-2025.

• 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: 23326548
• Report Number: 2029046-2025-03474
• Device Sequence Number: 10616761
• Product Code: MTD
• UDI-Device Identifier: 10846835012224
• UDI-Public: (01)10846835012224(17)280721(10)31714491L
• 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
• Report Date (Section B): 10/17/2025

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: D128208
• Device Lot Number: 31714491L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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: UNK ABLATION CATHETER; UNK_SMARTABLATE GENERATOR
• Patient Sex: Unknown