MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. GLADIUS MONGO 14; GUIDE WIRE

Catalog Number	AP14R023S
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	02/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The physician was initiating a cto pci cross of a mid-lad lesion that had significant calcification.He is very fond of the mongo wire as it is the best 3g wire he has.As he advanced the wire through the complex anatomy, he found that the wire became stuck.He felt that it was either behind a stent strut or was wedged badly into the 100% calcific lesion.As he pulled backward, the wire came apart on the spring coil and elongated.However, he was able to retrieve the entire wire and start over with a new one.The wire was retrieved successfully back into the corsair pro and removed from the body.The wire was immediately thrown away and a new one re-introduced.Wire was successfully retrieved back into the corsair pro and then back into the guide catheter.Physician was able to get through the lesion and treat the cto.

• Brand Name: GLADIUS MONGO 14
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 9724123
• Report Number: 3004718255-2020-00133
• Device Sequence Number: 19367984
• Product Code: DQX
• UDI-Device Identifier: 14547327123683
• UDI-Public: (01)14547327123683(17)220731(10)190833A011
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2020
• Report Date (Section F): 02/18/2020

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: 07/31/2022
• Device Catalogue Number: AP14R023S
• Device Lot Number: 190822A011
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/07/2020
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 116
• Date Report Sent to FDA: 02/18/2020