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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/27/2026
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 not returned to manufacturer and the investigation is concluded.
Event or Problem Description
It was reported "date of event: 27jan2026 customer: st (b)(6) [united states] blue coating scraped off and ended up into the patient's urethra.Unknown if the device was retrieved or not.Image of complaint device supplied separately.".

• 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: timothy desaulniers ; 5030 centerville road; st. paul, MN 55127
• MDR Report Key: 24957988
• Report Number: 3008988055-2026-00004
• Device Sequence Number: 21355534
• Product Code: EZB
• UDI-Device Identifier: 00827002448469
• UDI-Public: 00827002448469
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2026

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?: No
• 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: 03/23/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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