MAUDE Adverse Event Report: BOSTON SCIENTIFIC V18 GUIDEWIRE

Model Number V18

Device Problems Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 04/26/2016

Event Type  Injury  

Event Description

Pt was on the table for a complex left sfa (superficial femoral artery cto (chronic total obstruction).Access was right groin attempted to cross the cto without success.Access then attempted left posterior tibial.The v18 wire was inserted and attempted to cross the lesion approx 3 inches of the wire sheared off in the artery.Attempts to retrieve.Successfully snare and removed once procedure was complete.No wire remnants left behind.Wire to vendor and complaint filed with vendor april 28.

• Brand Name: V18 GUIDEWIRE
• Type of Device: V18 GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC; boston MA
• MDR Report Key: 5705330
• MDR Text Key: 46857334
• Report Number: MW5062715
• Device Sequence Number: 1
• Product Code: DQX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/03/2016

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
• Device Operator: Health Professional
• Device Model Number: V18
• Device Lot Number: 18401530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/03/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization