MAUDE Adverse Event Report: MEDCOMP 2.6F X 50CM DUAL LUMEN PICC; VASCU-PICC

Model Number	MR17012601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Swelling (2091)
Date of Event	12/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without an evaluation of the device involved we are unable to determine the cause or factors that may have contributed to this event.
Event or Problem Description
The team was concerned about patient discomfort when the picc line was manually flushed.One of the lumens had no blood return.Chest x-ray demonstrated a distinct area of discontinuation in the region of the left axilla-which was swollen.The decision was made to remove the line, but not at the bedside.In the or the surgeon pulled out the picc line under fluoroscopy to the point of the discontinuation which revealed a fracture.There were several cm of intact picc line still in the vein.The fractured portion of the line was cut off and threaded with a 0.014 guidewire through the portion of the picc that remained in the vein.Using the guidewire the remaining portion of the line was removed and was determined to be intact.With the guidewire in place a new picc was cut to the proper length and passed over the guidewire.It drew and flushed.Fluoroscopy confirmed good position.The patient tolerated the procedure well.

• Brand Name: 2.6F X 50CM DUAL LUMEN PICC
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7251688
• Report Number: 2518902-2018-00007
• Device Sequence Number: 1250473
• Product Code: LJS
• UDI-Device Identifier: 00884908085693
• UDI-Public: 884908085693
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2018

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: Health Professional
• Device Expiration Date: 09/29/2020
• Device Model Number: MR17012601
• Device Catalogue Number: MR17012601
• Device Lot Number: MJLM470
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 02/08/2018
• 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 Weight: 9