MAUDE Adverse Event Report: PAJUNK STIMULONG SONO II NANOLINE®

Catalog Number	521187-32A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigations are ongoing.Final evaluation will be sent to agency when finished.
Event or Problem Description
Irn#(b)(4).Incident occurred in france: tentative translation: interscalene catheter placement under arterial stim and ultrasound.Catheter removal following observation of blood return.During removal, the catheter broke, leaving 7 cm inside the patient, out of reach.
Additional Manufacturer Narrative
This is a follow up report which summarizes the results of investigations for this incident.Information about the investigation have been added and the imdrf updated accordingly.Furthermore, the expiry date of the affected device have been corrected.This case is considered as closed.If further information becomes available an update of the report will be sent to the agency.
Event or Problem Description
Irn# (b)(4) incident occurred in france: tentitive translation: interscalene catheter placement under arterial stim and ultrasound.Catheter removal following observation of blood return.During removal, the catheter broke, leaving 7 cm inside the patient, out of reach.

• Brand Name: STIMULONG SONO II NANOLINE®
• Common Device Name: STIMULONG SONO II NANOLINE®
• Manufacturer (Section D): PAJUNK; karl-hall-str.1; 78187, geisingen 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer Contact: armin pfeifer ; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 23494521
• Report Number: 9611612-2025-00045
• Device Sequence Number: 21076064
• Product Code: CAZ
• UDI-Device Identifier: 04048223114278
• UDI-Public: 04048223114278
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K053283
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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 Catalogue Number: 521187-32A
• Device Lot Number: 1593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2025
• 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: Other
• Patient Sex: Unknown