MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. MICRO-STICK SETMICRO-STICK SET; MICRO-STICK INTRODUCER

Model Number	MR190411
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
While attempting to gain arterial access using the guidewire, it was noted that the artery was occluded with plague.When the surgeon attempted to withdraw the guidewire, it appeared to have become hooked on the plague, causing the guidewire to stretch.In the process, the outer coating of the guidewire became dislodged, and a fragment of the coating remained within the vessel.
Additional Manufacturer Narrative
The picture of the guidewire that was provided appears to be a different guidewire than what was returned.The guidewire in the picture appears stretched and the end of the wire is unraveled.A visual evaluation of the 0.018" guidewire that was returned for evaluation revealed no obvious defects.All relative measurements were taken and reveal the device is within specification.Both ends of the wire were viewed under magnification.The "floppy" end of the wire is wrapped in an outer coil, which is intact, as is the ball tip holding the coil in place.No problem was found with the returned device.Without an evaluation of the device involved in the incident no root cause evaluation can be performed.The information provided indicated the patient's vein contained plaque and that the outer coating of the guidewire detached and remained in the patient.The guidewire in this complaint does not contain an outer coating of any kind.It is possible it was plaque that was dislodged when inserted into the vein.The instructions for use (ifu) contain the following warnings: *do not advance the guidewire against resistance until the cause of the resistance has been determined.*do not insert or withdraw the guidewire forcibly from any component.The wire may break or unravel.If the guidewire becomes damaged, the introducer needle or sheath dilator and guidewire must be removed together.*do not proceed if resistance is felt or interaction between components is failing.

• Brand Name: MICRO-STICK SETMICRO-STICK SET
• Common Device Name: MICRO-STICK INTRODUCER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 24001921
• Report Number: 2518902-2026-00004
• Device Sequence Number: 13361657
• Product Code: DYB
• UDI-Device Identifier: 00884908085440
• UDI-Public: (01)00884908085440(17)300509(10)MRTM930
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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: Other
• Device Model Number: MR190411
• Device Catalogue Number: MR190411
• Device Lot Number: MRTM930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown