MAUDE Adverse Event Report: STRYKER TERUMO; RADIFOCUS GLIDEWIRE ANGLED

Model Number GR3806

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 02/26/2014

Event Type  Injury  

Event Description

Attempted and aborted double lumen hickman placement.Glidewires sheared off leaving remaining part of wire in pt.Pt needed to go to interventional radiology for removal of wire and placement of hickman catheter.

• Brand Name: TERUMO
• Type of Device: RADIFOCUS GLIDEWIRE ANGLED
• Manufacturer (Section D): STRYKER; phoenix AZ
• MDR Report Key: 3672566
• MDR Text Key: 18796877
• Report Number: MW5034870
• Device Sequence Number: 1
• Product Code: HTO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/04/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: GR3806
• Device Catalogue Number: GR3806
• Device Lot Number: 430106
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2014
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR