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	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
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 was concluded.
Event or Problem Description
It was reported "on the(b)(6) 2025 the wire started to shred inside the patient.Pieces of teflon detached inside the patient and had to be retrieved with a basket.All parts were retrieved.They were able to successfully complete the procedure.Additional information received: when did the event occur? (prior to use, during insertion, during removal, etc.) -unkr please describe the access site was well as the target location for use of the wire.-urethra, bladder.Describe the patient's anatomy and disease severity.(vessel, calcification, tortuosity, angulation, etc.)? -unkr was the wire altered from its original condition prior to use? -unkr, no.What is the patient's status or outcome? -fine.Have any kinds of intervention, additional procedures been performed? -removal of device fragments.What pre-existing conditions/co-morbidities did the patient have? -unkr.What other medical devices were utilized in this case? please provide the manufacturer, brand, size, and part number if possible.-unkr.Was the wire altered from its original condition prior to use? -unkr.Was any kinking of the wire noted? (if so, are sharp edges present) -no.Can photos or video from the procedure, (during and/or after) or of the device be provided? -possibly.Is the patient tested positive to any infectious diseases? -unk.".
Additional Manufacturer Narrative
The report 3008988055-2025-00013 is being amended to add the correct the fda coding for investigation findings.

• 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: tim desaulniers ; 5030 centerville road; st. paul 55127
• MDR Report Key: 23550458
• Report Number: 3008988055-2025-00013
• Device Sequence Number: 15817036
• Product Code: EZB
• UDI-Device Identifier: 00827002448469
• UDI-Public: 00827002448469
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 01/27/2026

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
• Device Lot Number: 9019272681
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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