MAUDE Adverse Event Report: HERAEUS MEDICAL COMPONENTS, LLC SOLO PLUS HYBRID GUIDEWIRE; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	HW35SA
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
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.
Event or Problem Description
It was reported that the stent (material #778726- pr# (b)(4)) and guidewire (material # hw35sa- pr# (b)(4) ) had no information on box or product inside.

• Brand Name: SOLO PLUS HYBRID GUIDEWIRE
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): HERAEUS MEDICAL COMPONENTS, LLC; 5030 centerville road; saint 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; saint paul, MN 55127
• MDR Report Key: 17274159
• Report Number: 3008988055-2023-00005
• Device Sequence Number: 17027743
• Product Code: EZB
• UDI-Device Identifier: 00816840020319
• UDI-Public: (01)00816840020319(17)251003(10)9011393475
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2023

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 Expiration Date: 10/03/2025
• Device Model Number: HW35SA
• Device Catalogue Number: HW35SA
• Device Lot Number: 9011393475
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2022
• 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