MAUDE Adverse Event Report: ASAHI INTECC GLADIUS MONGO ES; GUIDE WIRE

Model Number AP14R324S

Device Problems Unraveled Material (1664); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 12/22/2021

Event Type  malfunction  

Event Description

Mongo wire coating on the tip of the wire became unraveled and dislodged into a branch of the r posterior tibial artery.

• Brand Name: GLADIUS MONGO ES
• 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: 13481830
• MDR Text Key: 287892573
• Report Number: 3004718255-2022-00249
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04547327123747
• UDI-Public: (01)04547327123747(17)240531(10)210602A011
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AP14R324S
• Device Catalogue Number: AP14R324S
• Device Lot Number: 210602A011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2022
• Distributor Facility Aware Date: 01/20/2022
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 128 KG