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

Model Number	N/A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was scheduled for right lower extremity angio with intervention of an occluded sfa with isr.Access was the right posterior tibial artery by micropuncture and upsized to a 6 french sheath.Physician used an 035 trailblazer catheter and gladius mongo es 014 guidewire to attempt to cross cto of isr of right sfa.The mongo es and catheter made its way distal towards the ostium of the sfa where proximal cto cap was.After spining the wire and pushing within the lesion, the radiopaque segment and tip of the wire broke off.Physician noted he was spining aggressively but has used that technique for years.There was no patient harm and we continued to work on the patient with a 035 system that eventually crossed and we successfully treated the patient.The wire fragment was left in the patient, most likely tacked up with stent.Successful case with mongo es tip breakage being the incident.No investigation is necessary.Facility discarded device and was not overly concerned.Please advise if you need any other information.

• Brand Name: GLADIUS MONGO ES
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 480-0 071; JA 480-0071
• MDR Report Key: 11486118
• Report Number: 3004718255-2021-00205
• Device Sequence Number: 14439445
• Product Code: DQX
• UDI-Device Identifier: 14547327123751
• UDI-Public: (01)14547327123751(17)230331(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): 03/03/2021
• Report Date (Section F): 03/15/2021

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: 03/03/2021
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2021
• 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: 03/15/2021