MAUDE Adverse Event Report: GLADIUS MONGO; GUIDE WIRE

Model Number	AP14R023S
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Physician tried to wire diagonal with support from corsair pro xs.Had difficulty wiring thru calcium and disease, tried to advance corsair pro xs, but could not.Brought mongo out of body to inspect and saw the distal portian of jacket was off wire.He then used a new mongo which took a different patch which was more luminal and successful completed case.

• Brand Name: GLADIUS MONGO
• Common Device Name: GUIDE WIRE
• MDR Report Key: 12648282
• Report Number: 3004718255-2021-00239
• Device Sequence Number: 4994672
• Product Code: DQX
• UDI-Device Identifier: 04547327123686
• UDI-Public: (01)04547327123686(17)240430(10)210505A131
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2021
• Report Date (Section F): 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: AP14R023S
• Device Catalogue Number: AP14R023S
• Device Lot Number: 210505A131
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/12/2021
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/18/2021