MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 5F X 20CM SINGLE CT MIDLINE

Model Number	MLCT5S20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	05/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During midline positioning maneuver in the right basilica vein, impossibility of removing the metallic guide.The vascular surgeon is contacted, who removed the guide with the finding of braking of it and the presence of a fragment of the end, deemed to be an extravascular lever, in the context of perivascular hematoma.Actions: intervention by the vascular surgeon and finding of the breaking; metal guidewire removed; ecg rx right humerus performed and vascular re-assessment.No indication for surgical removal of the retained fragment.
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.
Additional Manufacturer Narrative
The 0.018" guidewire was returned for evaluation.Visual inspection revealed the outer coil is broken approximately 35 cm from the proximal end, 0.3 cm from the point it is attached to the nitinol core wire.Under magnificatoin it can be seen that the outer coil is properly attached to the core wire but unravels 0.3 cm from the point of attachment.The unraveled portion continues for approximately 0.8 cm in which the core wire is exposed, then the outer coil begins again.It can be felt that the core wire is broken approximately 1 cm from that point.The outer coil on the distal end of the wire is completely unraveled and stretched, no core wire can be seen.The device was further reviewed by medcomp engineering.Their evaluation revealed the ball weld on the tip of the guidewire is broken off, causing the core wire to snap and the outer coil to break and unravel.The condition of the returned device suggests it was subjected to forces greater than it is designed to withstand.A possible scenario is pulling the wire back against the beveled edge of the needle.When the introducer needle is used, the guidewire should not be withdrawn against the needle bevel to avoid possible severing of the guidewire.The needle provided in this kit includes a green marker on the hub of the needle to ensure the needle is inserted with the bevel in the correct position.A definitive root cause cannot be determined but is not likely manufacture related.The instructions for use (ifu) contains the following warnings and precautions: *do not advance the guidewire or catheter if unusual resistance is encountered.*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.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.

• Brand Name: 5F X 20CM SINGLE CT MIDLINE
• Common Device Name: CT MIDLINE
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 19498076
• Report Number: 2518902-2024-00047
• Device Sequence Number: 7870494
• Product Code: PND
• UDI-Device Identifier: 00884908113754
• UDI-Public: 00884908113754
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 08/09/2024

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 Expiration Date: 08/16/2026
• Device Model Number: MLCT5S20
• Device Catalogue Number: MLCT5S20
• Device Lot Number: MQXB150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2023
• 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 Age: 21 YR
• Patient Sex: Unknown