MAUDE Adverse Event Report:; GUIDEWIRE

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/30/2015

Event Type  malfunction  

Event Description

Wire placed during needle localization was in incorrect place.Wire was pulled but a small fragment broke off and remained in the patient's breast.Information was shared with the patient and included in the post procedure note.

• Type of Device: GUIDEWIRE
• MDR Report Key: 4908432
• MDR Text Key: 6541782
• Report Number: 4908432
• Device Sequence Number: 1
• Product Code: MIJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2015
• Patient Sequence Number: 1
• Patient Age: 75 YR