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

Model Number	AP14R023S
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
He was trying to get through a very calcified lesion with the mongo wire.As he was trying to advance the wire through the lesion, tip became lodged in the calcium.When he tried to remove by pulling on the wire, but it did not release from the calcium.He pulled harder and that is when the wire tip separated.That is what happened with both wires.He was more frustrated about losing wire position then with the wire tip separation.He finished he case using two more mongos with no issues.He stented over the wire tips that were in the sub-intimal space and there was no issue for the patient.He also used mongo again today in another cto with no problem.

• Brand Name: GLADIUS MONGO
• 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: 10222147
• Report Number: 3004718255-2020-00146
• Device Sequence Number: 16917342
• Product Code: DQX
• UDI-Device Identifier: 04547327123686
• UDI-Public: (01)04547327123686(17)221130(10)191204A371
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2020
• Report Date (Section F): 07/01/2020

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: No Information
• Device Expiration Date: 11/30/2022
• Device Model Number: AP14R023S
• Device Catalogue Number: AP14R023S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/24/2020
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Date Report Sent to FDA: 07/01/2020