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

Model Number	N/A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) had two more gladius mongo es pre-shape wires detached and come apart at the distal end of the wire.Two separate cases.Both sfa interventions.Low to moderate calcium and subtotaled lesions.Access was both pedal and cfa respectively.This is the third pre-shape mongo es this user has had a breakage within a two week timeframe all the same lot#.Physician managed to remove both wires intact, held together somehow and finished case intervention without a problem.Patient is ok and case completed successfully.No other information given and product not saved.

• Brand Name: GLADIUS MONGO ES
• 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: 11564165
• Report Number: 3004718255-2021-00206
• Device Sequence Number: 4206581
• Product Code: DQX
• UDI-Device Identifier: 14547327123751
• UDI-Public: (01)14547327123751(17)0230331(10)200428A031
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/18/2021
• Report Date (Section F): 03/24/2021

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: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: AP14R324P
• Device Lot Number: 200428A031
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/18/2021
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/24/2021