MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. FLEX-NECK; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	00884450330210
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	02/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Female patient in her 50¿s, with a newly inserted peritoneal dialysis catheter.Returned for removal of the peritoneal dialysis catheter 5 days later, because the catheter was fractured, leaving only the internal segment.The physician's visual inspection identified the fracture was at the level of the superficial catheter cuff.Day 5: unplanned procedure for removal of catheter.Day 5: cipro x 10 days, follow up visit 2 weeks and new catheter to be inserted after site is healed.Day 15: per dr.- he feels there probably was a defect in the catheter because when looking back at the pictures it looks like there was some extravasation which he thought originally was just flowing back the track.

• Brand Name: FLEX-NECK
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 11434936
• Report Number: 11434936
• Device Sequence Number: 4710977
• Product Code: DRE
• UDI-Device Identifier: 00884450330210
• UDI-Public: (01)00884450330210(17)230620(10)H1856197(01)00884450330210
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/04/2021
• Report Date (Section F): 03/04/2021

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: Health Professional
• Device Model Number: 00884450330210
• Device Catalogue Number: CF-5460/C
• Device Lot Number: H1856197
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2021
• 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: Life Threatening; Other; Required Intervention
• Patient Weight: 84
• Date Report Sent to FDA: 03/04/2021