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

Catalog Number	D128207
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with a pentaray nav high-density mapping eco catheter and towards the end of the case, it was noticed that the catheter was no longer flushing at all.The medical team stated that the catheter was able to be flushed at the beginning of the case and during the case.The issue was discovered after completing all left atrium ablations and mapping.Troubleshooting went as follows: the medical team disconnected and reconnected irrigation tubing from catheter to ensure flow through tubing.The pressure in the bag was checked.The issue was not resolved.The physician mapped the right atrium (ra) with the pentaray after the issue was discovered.The device was not replaced.The procedure continued.No patient consequences were reported.
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
On 27-feb-2025, 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 high-density mapping eco catheter and towards the end of the case, it was noticed that the catheter was no longer flushing at all.The medical team stated that the catheter was able to be flushed at the beginning of the case and during the case.The issue was discovered after completing all left atrium ablations and mapping.Troubleshooting went as follows: the medical team disconnected and reconnected irrigation tubing from catheter to ensure flow through tubing.The pressure in the bag was checked.The issue was not resolved.The physician mapped the right atrium (ra) with the pentaray after the issue was discovered.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 no damage or anomalies on the device.An irrigation test was performed, and the catheter failed the test since the irrigation tube was found bent inside the tip.A manufacturing record evaluation was performed for the finished device number lot 31514655l and no internal action related to the complaint was found during the review.The irrigation issue reported by the customer was confirmed.The bent could be related to the manipulation of the device during the procedure; however, this could not be conclusively determined.The instructions for use contain the following recommendations: flush the catheter with heparinized saline prior to insertion into the body.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through j&j medtech's quality system.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 HIGH-DENSITY MAPPING ECO CATHETER
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21267442
• Report Number: 2029046-2025-00298
• Device Sequence Number: 3664760
• Product Code: MTD
• UDI-Device Identifier: 10846835012217
• UDI-Public: (01)10846835012217(17)271125(10)31514655L
• 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
• Report Date (Section B): 03/19/2025

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: D128207
• Device Lot Number: 31514655L
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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: FARAPULSE GENERATOR.
• Patient Sex: Unknown