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

Catalog Number	PP18R304S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Mongo 18 wire was used to knuckle & cross sfa cto approximately 100cm long.Knuckled wire was pushed with 90cm angled navicross & tip sustained moderate damage and became misshapen.Mongo was exchanged for grand slam and lesion was treated with directional atherectomy and self-expanding stent.Stent struts were damaged when spider filter wire became tangled in struts upon capture and removal.Mongo was used later in procedure to deliver.018 diameter shaft balloons through damaged stent struts.While trying to remove mongo, the damaged tip became tangled in the damaged stent struts and approximately 1cm was separated from rest of core wire in the body.The tip fragment was then removed using a goose-neck snare through a 6fr guide catheter and long 6fr sheath.

• 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: 19473194
• Report Number: 3004718255-2024-00330
• Device Sequence Number: 3981722
• Product Code: DQX
• UDI-Device Identifier: 04547327143219
• UDI-Public: (01)04547327143219(17)260731(10)230807A202
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/05/2024
• Report Date (Section F): 06/05/2024

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: 07/31/2026
• Device Catalogue Number: PP18R304S
• Device Lot Number: 230807A202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/13/2024
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 06/05/2024