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

Lot Number 21485795

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2018

Event Type  malfunction  

Event Description

Second case/second report: luge wire was not shaping appropriately.Three wires out of four wouldn't work.After the first wire wouldn't work, a second one was used and worked for a pci.For the second pci on the same patient, the third wire would not shape either.Another wire was pulled, but that one seemed to have the same issue.All of these wires are from lot # 21485795.The fourth wire that was used was a floppy wire and worked fine.Pt was not affected.

• 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: 7302291
• MDR Text Key: 101139956
• Report Number: 7302291
• 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: 02/01/2018,02/09/2018

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 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: 02/01/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR