MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG ECHO NANOLINE

Catalog Number	531185-31C
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Irn# (b)(4).Incident occurred in italy: tentitive translation: the catheter fractured and a fragment was retained within the patient; therefore, a surgical incision was required to retrieve the retained portion.
Additional Manufacturer Narrative
This case is considered as closed.If further information becomes available an update will be send to the agency.

• Brand Name: SONOLONG ECHO NANOLINE
• Common Device Name: SONOLONG ECHO NANOLINE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• Manufacturer Contact: armin pfeifer ; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• MDR Report Key: 24713591
• Report Number: 9611612-2026-00004
• Device Sequence Number: 20253236
• Product Code: CAZ
• UDI-Device Identifier: 04048223126790
• UDI-Public: 04048223126790
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K113188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

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
• Device Catalogue Number: 531185-31C
• Device Lot Number: 1605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown