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

Catalog Number	AP14R324S
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Gladius mongo 14 es was used down posterior tibial thru pedal loop to gain access to the anterior tibial artery from the retrograde and was in the process of being snared out with a ensnare 6-10mm snare device for externalization of the wire.Snare only captured the very distal tip of the wire before physician started to pull to externalize wire.The gladius mongo 14 es started to unravel but was able to be removed safely, without injury or incidence.No fragments were left behind and a new gladius mongo 14 es was opened and replaced the damaged wire.

• 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: 17510769
• Report Number: 3004718255-2023-00302
• Device Sequence Number: 5460024
• Product Code: DQX
• UDI-Device Identifier: 04547327123747
• UDI-Public: (01)04547327123747(17)250731(10)220727A011
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2023
• Report Date (Section F): 08/11/2023

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: 07/31/2025
• Device Catalogue Number: AP14R324S
• Device Lot Number: 220727A011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/01/2023
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male
• Date Report Sent to FDA: 08/11/2023