MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MERIT MAK¿; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	00884450012598
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with history of coronary artery disease, elevated cholesterol and asthma.During the procedure- transcatheter aortic valve replacement (tavr), the wire got stuck in the mini stick sheath access and had to be removed.Access had to be regained, without known harm to the patient.

• Brand Name: MERIT MAK¿
• 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: 9828861
• Report Number: 9828861
• Device Sequence Number: 2886062
• Product Code: DRE
• UDI-Device Identifier: 00884450012598
• UDI-Public: (01)00884450012598
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/03/2020
• Report Date (Section F): 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 00884450012598
• Device Catalogue Number: MAK401N-E/C
• Device Lot Number: L1693920
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 28
• Date Report Sent to FDA: 03/03/2020