MAUDE Adverse Event Report: MEDCOMP 4FX20CM SGL CT MID LINE; CT MIDLINE

Model Number MLCT4S20FN

Device Problems Knotted (1340); Device Handling Problem (3265)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated.When the investigation is complete a final report will be submitted.

Event Description

Upon insertion of the wire, resistance was met.The wire was retracted.An second attempt to reinsert the wire, it wouldn't go through and then was hard to retract fully.Another try to pull it out was made and the wire came out coiled and knotted at the tip.

Manufacturer Narrative

Based on the investigation performed, it was determined that the product was manufactured to specifications at this time.The knot at the tip of the guidewire was confirmed, but we are unable to determine the cause or factors that contributed to this event.Previous investigations by the device manufacturer stated that possible contributing factors to the event may have been resistance in the guidewire during insertion and/or the patient's anatomy.The instructions for use state "do not advance the guidewire or catheter if unusual resistance is encountered".

• Brand Name: 4FX20CM SGL CT MID LINE
• Type of Device: CT MIDLINE
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 7161411
• MDR Text Key: 96712905
• Report Number: 2518902-2017-00069
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00884908113631
• UDI-Public: 884908113631
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/01/2019
• Device Model Number: MLCT4S20FN
• Device Catalogue Number: MLCT4S20FN
• Device Lot Number: MCBC530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2017
• Date Device Manufactured: 08/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention