MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Catalog Number	NS7TCFL174HS
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product investigation was completed.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection of the returned device were performed.Visual inspection revealed the connector detached from the handle.The polyurethane (pu) was not correctly applied on the connector.Manufacturing investigation was performed to the potential cause of the connector detachment.Once the connector was detached from the catheter, it was observed that connector did not have enough pu (polyurethane).A manufacturing record evaluation was performed for the finished device [31238538m] number, and no internal actions related to the reported complaint condition were identified.The connector issue reported by the customer was confirmed.The potential cause for the connector detachment was an improper pu (polyurethane) application.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).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a navistar¿ electrophysiology catheter and post procedure the bwi product analysis lab identified that the connector was detached from the handle.During the procedure itself, the medical team discovered that the catheter tip was defective.The tip of the cable entry on the catheter would come off.The issue was noted before usage, so this device never touched the patient.The catheter was changed and the procedure continued.No patient consequences were reported.
Additional Manufacturer Narrative
Per internal review on 10-dec-2025, the product investigation was updated with a mistakenly omitted detail from section h11.The missing information is as follows: the connector issue reported by the customer was confirmed.The potential cause for the connector detachment was an improper pu (polyurethane) application.An awareness session was performed with the involved personnel to address this issue.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: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• 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: 20464151
• Report Number: 2029046-2024-03411
• Device Sequence Number: 15402046
• Product Code: DRF
• UDI-Device Identifier: 10846835000610
• UDI-Public: (01)10846835000610(17)270130(10)31238538M
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P990025
• 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): 01/07/2025

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: NS7TCFL174HS
• Device Lot Number: 31238538M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• 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
• Patient Sex: Unknown