MAUDE Adverse Event Report: ASAHI INTECC FIELDER XT; GUIDE WIRE

Catalog Number AGP140002

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/20/2024

Event Type  Injury  

Event Description

After stent deployment into the left main, attempted to rewire the lcx to complete a bifurcating stent process.The fielder xt crossed but was substent.While removing the fielder xt, the distal hydrophilic part uncoiled and was stuck under the lm stent.The tip became unattached.Several attempts were made to remove it but it was unsuccessful.

• Brand Name: FIELDER XT
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 19106150
• MDR Text Key: 340222331
• Report Number: 3004718255-2024-00327
• 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: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: AGP140002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2024
• Distributor Facility Aware Date: 03/25/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female