MAUDE Adverse Event Report: MEDLINE RENEWAL; EAGLE EYE PLAT ST DIGITAL IVUS 5FX150CM

Catalog Number	85900PSTRH
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) 2024 during the middle of a standard procedure, the device got stuck on a wire and they had difficulty removing it out of the body.After the issue, they used a different device and started over.There was a time delay to the procedure as well.The facility stated there was no impact to the patient and no impact to the procedure.A device is available for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility on (b)(6) 2024 during the middle of a standard procedure, the device got stuck on a wire and they had difficulty removing it out of the body.

• Common Device Name: EAGLE EYE PLAT ST DIGITAL IVUS 5FX150CM
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock avenue; redmond OR 94456 1876
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 21193464
• Report Number: 3032391-2025-00001
• Device Sequence Number: 18214017
• Product Code: OWQ
• UDI-Device Identifier: 00850065047058
• UDI-Public: 00850065047058
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/20/2025

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
• Device Expiration Date: 09/20/2025
• Device Catalogue Number: 85900PSTRH
• Device Lot Number: 300005383911-272429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown