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	Foreign Body In Patient (2687)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon was using a hybrid wire guide within the patient ureter and notice material shedding off from the wire causing it to stay within the ureter and bladder.Surgeon discontinued use of wire and request a different wire to be used.

• 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: 23531705
• Report Number: 23531705
• Device Sequence Number: 13028035
• 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: G44846
• Device Lot Number: 9019272681
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 49 KG
• Date Report Sent to FDA: 09/17/2025