MAUDE Adverse Event Report: ASAHI INTECC GLADIUS MONGO 14; GUIDE WIRE

Model Number	AP14R023S
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) working on cx cto.Was able to get gladius mongo gw across cto.He was using a mamba flex mc first.That was unable to cross cto.He asked for corsair pro xs.Was able to advance further but not totally across cto cap.He did clockwise and counter-clockwise rotations.The cp xs was not advancing ay further.He then went to remove the cp xs.He noticed that the tip of cp xs was broken off and was stuck on wire.On angio it didn't look like there was calcium but cto cap was extremely hard.

• Brand Name: GLADIUS MONGO 14
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 10721919
• Report Number: 3004718255-2020-00165
• Device Sequence Number: 17087123
• Product Code: DQX
• UDI-Device Identifier: 04547327123686
• UDI-Public: (01)04547327123686(17)221130(10)191209A081
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/12/2020
• Report Date (Section F): 10/22/2020

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: 11/30/2022
• Device Model Number: AP14R023S
• Device Catalogue Number: AP14R023S
• Device Lot Number: 191209A081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/12/2020
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Date Report Sent to FDA: 10/22/2020