MAUDE Adverse Event Report: HERAEUS MEDICAL COMPONENTS, LLC SOLO PLUS HYBRID GUIDEWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	HW38SA
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for physical analysis, therefore no device evaluation could be performed.Heraeus is unable to comment on the condition of the device or the cause of the occurence.If additional information is received, a follow up report will be submitted.
Event or Problem Description
It was reported that the guidewire broken off in the patient during a procedure on (b)(6) 2019 and was not discovered until the patient complained about pain after the procedure but the cause was unknown.The patient had to do a secondary procedure on an unknown date to remove the guidewire.

• Brand Name: SOLO PLUS HYBRID GUIDEWIRE
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): HERAEUS MEDICAL COMPONENTS, LLC; 2605 fernbrook lane north; suite j; plymouth MN 55447
• MDR Report Key: 8813191
• Report Number: 2135342-2019-00001
• Device Sequence Number: 13857495
• Product Code: OCY
• UDI-Device Identifier: 00816840020326
• UDI-Public: (01)00816840020326(17)200308(10)MO44542
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: HW38SA
• Device Catalogue Number: HW38SA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention