MAUDE Adverse Event Report: MERIT MEDICAL SYSTEM, INC. MERIT LAUREATE HYDROPHILIC GLIDEWIRE, 0.035 X 260CM TIP LENGTH 3CM; WIRE, GUIDE CATHETER

Model Number	LWSTDA35260EXVD
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Approx 10 cm section of glidewire proximal to tip separated from core and remained in left anterior tibial artery when wire was removed.Required angioplasty and snare device for removal of remaining wire fragment, requiring add'l imaging with iodinated contrast media.Diagnosis or reason for use: angiography and peripheral intervention.Is the product compounded? no; is the product over-the-counter? no.

• Brand Name: MERIT LAUREATE HYDROPHILIC GLIDEWIRE, 0.035 X 260CM TIP LENGTH 3CM
• Common Device Name: WIRE, GUIDE CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEM, INC. ; south jordan UT 84095
• MDR Report Key: 8203194
• Report Number: MW5082673
• Device Sequence Number: 16711062
• Product Code: DQX
• UDI-Device Identifier: 00884450033302
• UDI-Public: (01)00884450033302(17)210930(10)
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/26/2018

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 Expiration Date: 09/30/2021
• Device Model Number: LWSTDA35260EXVD
• Device Catalogue Number: G03330
• Device Lot Number: K1432015
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2018
• 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: Other; Required Intervention
• Patient Weight: 42