MAUDE Adverse Event Report: MEDCOMP 4F X 20CM SGL CT MIDLINE W/MAX

Model Number	MLCT4S20MB
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Currently waiting for the sample to be returned for evaluation.
Event or Problem Description
When nurse was placing the catheter, and tried to withdraw the wire she noticed tension.She notified the lip, who was able to get the wire and upon inspection noticed a large knot at the end.
Additional Manufacturer Narrative
One guidewire was received returned for evaluation.A visual inspection confirmed the report.The guidewire is knotted approximately 2 cm from the distal end.The root cause for the event could not be determined.The report indicated that they were unable to advance the guidewire.This may have led to the pushing in and pulling back of the wire.This technique may have caused the tip of the wire to loop over itself and become knotted preventing removal.

• Brand Name: 4F X 20CM SGL CT MIDLINE W/MAX
• Common Device Name: CT MIDLINE
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8247573
• Report Number: 2518902-2019-00005
• Device Sequence Number: 19221825
• Product Code: PND
• UDI-Device Identifier: 00884908113655
• UDI-Public: 884908113655
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K170770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2019

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: 10/31/2020
• Device Model Number: MLCT4S20MB
• Device Catalogue Number: MLCT4S20MB
• Device Lot Number: MKBN400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 179