MAUDE Adverse Event Report: TERUMO CORP. GLIDEWIRE; CARDIAC/PERIPHERAL VASCULAR GUIDEWIRE, SINGLE-USE

Catalog Number	GL3508
Medical Device Problem Code	Device Or Device Fragments Location Unknown (2590)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
When accessing the cephalic vein for a pacemaker insertion, a glidewire was inserted into the vein and the wire introducer was also advanced into the vein.Glidewire was removed from the vein but not the introducer.We were unable to visualize the introducer under fluoro.Based on packing lists for devices purchased for the cath lab prior to procedure lot# could be 171113.

• Brand Name: GLIDEWIRE
• Common Device Name: CARDIAC/PERIPHERAL VASCULAR GUIDEWIRE, SINGLE-USE
• Manufacturer (Section D): TERUMO CORP.; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 7464065
• Report Number: 7464065
• Device Sequence Number: 18026406
• Product Code: DQX
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2018
• Report Date (Section F): 04/17/2018

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: Physician
• Device Catalogue Number: GL3508
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/17/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2018
• 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
• Date Report Sent to FDA: 04/17/2018