MAUDE Adverse Event Report: HERAEUS MEDICAL COMPONENTS, LLC SOLO PLUS HYBRID GUIDWIRE; GASTRO-UROLOGY

Model Number	HW35FS
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/26/2018
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 during a cystoscopy, ureteroscopy, and laser lithotripsy directly with stone extraction, part of the hydrophilic guidewire was retained in the left ureter of the patient.Attempts to remove the part of the guidewire were unsuccessful.The surgery was completed and the patient was transferred to icu and later discharged from the hospital.

• Brand Name: SOLO PLUS HYBRID GUIDWIRE
• Common Device Name: GASTRO-UROLOGY
• Manufacturer (Section D): HERAEUS MEDICAL COMPONENTS, LLC; 2605 fernbrook lane n; suite j; plymouth MN 55447
• MDR Report Key: 7560860
• Report Number: 2135342-2018-00005
• Device Sequence Number: 1318226
• Product Code: EZB
• UDI-Device Identifier: 00816840020333
• UDI-Public: (01)00816840020333(17)200710(10)PL00329
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 05/10/2018

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: 07/10/2020
• Device Model Number: HW35FS
• Device Catalogue Number: HW35FS
• Device Lot Number: PL00329
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 06/01/2018
• 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