MAUDE Adverse Event Report: TERUMO TERUMO; STIFF ANGLED GLIDEWIRE

Model Number	GS3508
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Hydrophillic coating at tip of wire sheared off during ivc filter removal and left in patient.

• Brand Name: TERUMO
• Common Device Name: STIFF ANGLED GLIDEWIRE
• Manufacturer (Section D): TERUMO; somerset NJ
• MDR Report Key: 6485417
• Report Number: MW5069028
• Device Sequence Number: 1082046
• Product Code: DQX
• UDI-Device Identifier: 04987350773630
• UDI-Public: (01)04987350773630
• Initial Reporter State: GA
• 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): 04/10/2017

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: 01/31/2019
• Device Model Number: GS3508
• Device Catalogue Number: GS3508
• Device Lot Number: 170222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 65