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

Model Number	MHW-035150
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Guidewire broke while inside patient when using laser.Surgeon removed the broken pieces.Potential issue with laser hitting guidewire causing breakage.

• Brand Name: MOTION HYBRID WIRE GUIDE
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): HERAEUS MEDICAL COMPONENTS LLC; 5030 centerville road; saint paul MN 55127
• MDR Report Key: 23390185
• Report Number: 23390185
• Device Sequence Number: 18636616
• Product Code: EZB
• UDI-Device Identifier: 00827002448469
• UDI-Public: (01)00827002448469
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/02/2025
• Report Date (Section F): 10/02/2025

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
• Operator of Device: Health Professional
• Device Model Number: MHW-035150
• Device Catalogue Number: MHW-035150
• Device Lot Number: 9019157405
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Date Report Sent to FDA: 10/02/2025