MAUDE Adverse Event Report: BOSTON SCIENTIFIC 0.014 V-14 CONTROL GUIDEWIRE WITH A J; CATHETER, CORONARY, ATHERECTOMY

Lot Number 21606989

Device Problem Fracture (1260)

Patient Problems Occlusion (1984); Foreign Body In Patient (2687)

Event Date 03/26/2018

Event Type  Injury  

Event Description

Chronic total occlusion in left anterior tibial artery, wire buckled and when pulled back the tip of the wire remained within the subintimal space.Fragment retained in patient.

• Brand Name: 0.014 V-14 CONTROL GUIDEWIRE WITH A J
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 7388039
• MDR Text Key: 104213097
• Report Number: MW5076239
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2020
• Device Lot Number: 21606989
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR