MAUDE Adverse Event Report: HERAEUS MEDICAL COMPONENTS LLC MOTION HYBRID WIRE GUIDE; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	SP-4113-001
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This submission does not constitute a determination or admission that the device has malfunctioned or that the device was related to a death or injury.Device was discarded by user and is not available for evaluation.
Event or Problem Description
It was reported: "on (b)(6) 2025, (b)(6) (united states) was removed a motion hybrid wire guide from acmi semi rigid scope the coating sheared off the inside of the patient which caused a significant delay because the pieces needed to be basketed out of the patient.The procedure was a ureteroscopy with laser lithotripsy.It's unknown if all the all pieces of the coating were able to be removed.".
Additional Manufacturer Narrative
The report 3008988055-2025-00008 is being amended to add the correct the fda coding for investigation findings and conclusions.

• Brand Name: MOTION HYBRID WIRE GUIDE
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): HERAEUS MEDICAL COMPONENTS LLC; 5030 centerville road; st. paul MN 55127
• Manufacturer (Section G): HERAEUS MEDICAL COMPONENTS, SRL; parque industrial zona franca; la lima building 29; guadalupe, cartago 30106 ; CS 30106
• Manufacturer Contact: tim desaulniers ; 5030 centerville road; st. paul, MN 55127
• MDR Report Key: 22531872
• Report Number: 3008988055-2025-00008
• Device Sequence Number: 8017950
• Product Code: EZB
• UDI-Device Identifier: 00827002448469
• UDI-Public: 00827002448469
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• 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
• Device Model Number: SP-4113-001
• Device Catalogue Number: MHW-035150
• 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: 06/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 09/11/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown