MAUDE Adverse Event Report: TERUMO MEDICAL CORP. RADIFOCUS GLIDEWIRE; WIRE, GUIDE, CATHETER

Model Number GS3508

Device Problem Peeled/Delaminated (1454)

Patient Problem No Information (3190)

Event Date 11/21/2018

Event Type  Injury  

Event Description

It appears the coating over guidewire was sheared off during procedure.This was retrieved during ir intervention.On the package there is a cautionary statement: do not use with metal entry needle.Request of manufacturer to highlight and enlarge this cautionary statement on the package.

• Brand Name: RADIFOCUS GLIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORP. ; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 8180702
• MDR Text Key: 131193742
• Report Number: MW5082281
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GS3508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR