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 Codes	Peeled/Delaminated (1454); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
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 not concluded.
Event or Problem Description
It was reported: date of event: 25-feb-2026, customer: (b)(6) medical ctr [united states].Complex ureteroscopy case at end of day at syb.Had two separate wire issues wear coating came off distantly.One was a glide and one was either a motion or sensor wire.This hybrid wire may have resulted in foreign body (coating) stuck inside distal stent.See photos."just wanted to show you some images of some wires that came apart during a case at syb.The rn there did not save the packaging or the wires." i have not received any info on patient details nor item/lot numbers.".

• 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: 24887369
• Report Number: 3008988055-2026-00002
• Device Sequence Number: 13224611
• Product Code: EZB
• UDI-Device Identifier: 00827002448469
• UDI-Public: 00827002448469
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 05/12/2026

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?: 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: 03/17/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 05/12/2026
• 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