MAUDE Adverse Event Report: GYRUS ACMI, INC. SUREGLIDE; STYLET, URETERAL

Model Number	35BX
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Approximately 0.5cm piece of the lining of a guide wire broke off from the guide wire and was in the patient's body, until the surgeon removed it.

• Brand Name: SUREGLIDE
• Common Device Name: STYLET, URETERAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• MDR Report Key: 20450930
• Report Number: 20450930
• Device Sequence Number: 20610712
• Product Code: EYA
• UDI-Device Identifier: 00821925005730
• UDI-Public: 00821925005730
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/09/2024
• Report Date (Section F): 07/09/2024

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: 35BX
• Device Catalogue Number: 41
• Device Lot Number: 8768832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 10/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 2 MO
• Patient Sex: Female
• Patient Weight: 71 KG
• Date Report Sent to FDA: 07/09/2024