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

Model Number MLCT4S20

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

An investigation is ongoing.A follow up report will be submitted when the investigation is complete.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 Description

Guidewire tip knotted and broke into four (4) pieces which required surgery for removal.

Manufacturer Narrative

No device was returned and no photographs were provided.A review of the manufacture records was conducted by the guidewire contract manufacturer and revealed the device was manufactured according to specification with no non-conformances or deviations in place.Without an evaluation of the complained device a definitive root cause cannot be determined.The instructions for use contain the following caution statements: 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 avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4F SINGLE CT MIDLINE
• Type of Device: CT MIDLINE
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10174159
• MDR Text Key: 195748685
• Report Number: 2518902-2020-00024
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00884908113730
• UDI-Public: 884908113730
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/10/2023
• Device Model Number: MLCT4S20
• Device Catalogue Number: MLCT4S20
• Device Lot Number: MNXA650
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention