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	09/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Tip of a cook wire used for stent placement broke off inside of the patient during procedure.The surgeon removed the tip of the cook wire from the patient, reported the incident to the cook industry representative.

• 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: 23531733
• Report Number: 23531733
• Device Sequence Number: 9020883
• 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): 09/10/2025
• Report Date (Section F): 09/17/2025

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: 9019244136
• 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: 11/12/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2025
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 39 KG
• Date Report Sent to FDA: 09/17/2025