MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LUGE¿; WIRE, GUIDE, CATHETER

Model Number H74912130010

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2018

Event Type  malfunction  

Event Description

Dr attempted to shape the tip of the luge wire for use during a pci.But the wire would not shape.Dr used a different kind of wire to finish the intervention and worked fine.

• Brand Name: LUGE¿
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7317056
• MDR Text Key: 101629091
• Report Number: 7317056
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/14/2018,02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/07/2019
• Device Model Number: H74912130010
• Device Lot Number: 21485795
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 70 YR