MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 4F SINGLE CT MIDLINE

Model Number	MLCT4S20
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	09/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Difficult guidewire removal.It knotted on the distal tip.Ir procedure to remove.
Additional Manufacturer Narrative
Two.018" guidewires were returned for evaluation.The wire indicated to be for this complaint has a knot at the distal end.The other guidewire appears to have looped back around itself and formed a knot on the distal end.Both guidewires have a great deal of tissue entangled in the knotted area.After decontamination a large portion of the tissue was removed but it was not possible to remove all of it.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.A root cause cannot be determined but is not likely manufacture related.A possible cause of the knotted tip could be a back-and-forth (in and out) motion during insertion.This can cause the wire to fold back on itself and result in a knotted tip.This may also cause the wire to be difficult to remove, resulting in applying more forces than the device is designed to withstand in order to remove it.The instructions for use (ifu) contains the following cautions: *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: 4F 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: 12439233
• Report Number: 2518902-2021-00055
• Device Sequence Number: 14408446
• Product Code: PND
• UDI-Device Identifier: 00884908113730
• UDI-Public: 884908113730
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 07/15/2024
• Device Model Number: MLCT4S20
• Device Catalogue Number: MLCT4S20
• Device Lot Number: MPTA090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2021
• 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: 84 YR
• Patient Sex: Unknown