MAUDE Adverse Event Report: VASCOMED GMBH MULTICATH 10J CS O6F 2-8-2MM; CATHETER

Model Number	351191
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Ous - during removal of the catheter, the distal part dislodged.It wasnt used again.
Additional Manufacturer Narrative
A corrective and preventive action was initiated by this incident.In the cause of the root cause analysis the test method for the verification of the mechanical requirements of the welding joint was critically reinvestigated and proved as reliable.Based on the investigations, two possible roots causes were identified: 1.Standard operation procedure for test execution not followed.2.Welding joint impaired by user.
Event or Problem Description
Ous - during removal of the catheter, the distal part dislodged.It wasn't used again.

• Brand Name: MULTICATH 10J CS O6F 2-8-2MM
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCOMED GMBH; hertzallee 1; binzen 79589 ; DE 79589
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 21159858
• Report Number: 1028232-2025-00225
• Device Sequence Number: 8419673
• Product Code: DRF
• UDI-Device Identifier: 04260090928967
• UDI-Public: 04260090928967
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K201445
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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 Model Number: 351191
• Device Catalogue Number: 351191
• Device Lot Number: 09239283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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