MAUDE Adverse Event Report: BOSTON SCIENTIFIC V18 CONTROL WIRE; GUIDE WIRE

Model Number	46-860
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/05/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Tip of boston scientific v-18 control wire broke off during femoral angioplasty.Tip had to be jailed against vessel wall with stent.

• Brand Name: V18 CONTROL WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC; global park, heredia ; CS
• MDR Report Key: 5462883
• Report Number: MW5060519
• Device Sequence Number: 274325
• Product Code: DQX
• UDI-Device Identifier: 08714729070238
• UDI-Public: 08714729070238
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/08/2017
• Device Model Number: 46-860
• Device Catalogue Number: MOO1468600
• Device Lot Number: 18610190
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2016
• 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: Required Intervention
• Patient Age: 69 YR