MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; INTERVENTIONAL TRAY

Model Number	DYNJ65593A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) 2023 during an aneurysm embolization "fibers came loose but did not exit the micro catheter into the patient, the micro catheter and wire were removed when it was discovered to have difficulties moving the micro wire, and on the back table the micro catheter was flushed with saline and a small piece of lint was expelled out of the catheter".
Additional Manufacturer Narrative
According to the facility on (b)(6) 2023 during an aneurysm embolization "fibers came loose but did not exit the micro catheter into the patient, the micro catheter and wire were removed when it was discovered to have difficulties moving the micro wire, and on the back table the micro catheter was flushed with saline and a small piece of lint was expelled out of the catheter".Per the facility there was no impact to the patient as the event was described as a "near miss".However, per the facility "the procedure had to be paused to inspect all towels and product for lint".Per the facility the towels were thrown away and are not available to be returned for evaluation.No additional information is available at this time.The sample is not available to be returned 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.

• Brand Name: Medline Industries, Inc.
• Common Device Name: INTERVENTIONAL TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16516847
• Report Number: 1423395-2023-00010
• Device Sequence Number: 12294437
• Product Code: OES
• UDI-Device Identifier: 10193489473896
• UDI-Public: 10193489473896
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 03/09/2023

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: DYNJ65593A
• Device Catalogue Number: DYNJ65593A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown