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

Model Number AP14R023S

Device Problems Break (1069); Fracture (1260); Difficult to Remove (1528); Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Date 02/10/2022

Event Type  malfunction  

Event Description

During cardiac catheterization, guide wire was fractured and unable to be retrieved from the small branch of the distal obtuse marginal (om) chronic total occlusion (cto).What was the original intended procedure?: impella cp percutaneous lvad insertion and removal.What problem did the user have (check all that apply): device failed (e.G.Broke, couldn't get it to work or stopped working).

• Brand Name: GLADIUS MONGO
• 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: 13983750
• MDR Text Key: 294146646
• Report Number: 3004718255-2022-00252
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04547327123686
• UDI-Public: (01)04547327123686(17)240731(10)210816A361
• 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: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AP14R023S
• Device Catalogue Number: AP14R023S
• Device Lot Number: 210816A361
• 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: 04/01/2022
• Distributor Facility Aware Date: 03/21/2022
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male