MAUDE Adverse Event Report: STOCKERT GMBH INTELLAGEN; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	M004GEN100206251
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that no fluid came out from the catheter when flushing was attempted.During a pulmonary vein isolation (pvi) procedure, an intellagen tubing set and an intellanav stablepoint open-irrigated catheter were selected for use in the left atrium.During preparation, flushing was attempted outside the patient's body, but no fluid came out from the catheter.Both components were replaced to resolve the problem.The procedure was successfully completed with no patient complications.The devices were discarded and will not be returned for analysis.Note: this reported pertains to one of two devices used during the same procedure.Refer to manufacturer report 2124215-2025-84375 for the associated device information.

• Brand Name: INTELLAGEN
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): STOCKERT GMBH; botzinger str. 31; freiburg im breisgau 79111 ; GM 79111
• Manufacturer (Section G): STOCKERT GMBH; botzinger strasse 72; freiburg 79111 ; GM 79111
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23594901
• Report Number: 2124215-2025-84535
• Device Sequence Number: 13067142
• Product Code: OAD
• UDI-Device Identifier: 04260166374353
• UDI-Public: (01)04260166374353(17)260415(10)24
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2025

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 Expiration Date: 04/15/2026
• Device Model Number: M004GEN100206251
• Device Catalogue Number: M004GEN100206251
• Device Lot Number: 0000000024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 11/19/2025
• Date Device Manufactured: 04/15/2024
• 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