MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE EPILONG II TUOHY

Model Number	02115137CB
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rn# (b)(4).Complaint took place in (b)(6).In case new information becomes available a follow up report will be sent to the agency.
Event or Problem Description
Irn# (b)(4) incident occurred in (b)(6): upon completion of the procedure, during catheter withdrawal, the distal tip of the catheter was retained within the patient.

• Brand Name: EPILONG II TUOHY
• Common Device Name: EPILONG II TUOHY
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 23051994
• Report Number: 9611612-2025-00041
• Device Sequence Number: 21249088
• Product Code: CAZ
• UDI-Device Identifier: 04048223119495
• UDI-Public: 04048223119495
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K060311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/02/2024
• Device Model Number: 02115137CB
• Device Catalogue Number: 033115201-51
• Device Lot Number: 1556
• 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: 08/01/2025
• Initial Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown