MAUDE Adverse Event Report: FILMECC CO., LTD. VASSALLO GT; GUIDE WIRE

Catalog Number	VGT14300HYB
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Vassallo gt hybrid.014 ("the product") was used for the lesion with 250mm 100% stenosis moderate calcification.Antegrade femoral approach was attempted first with the product, unsuccessfully.While tibial / pedal approach was then attempted with the product, the distal end broke off inside the patient.The foreign object was able to be removed from the patient by balloon catheter.The product was used with a saber.014" balloon, 3.5mm x300 mm.

• Brand Name: VASSALLO GT
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): FILMECC CO., LTD.; 1703 wakita-cho; moriyama-ku; nagoya-shi, aichi 463-0 024; JA 463-0024
• MDR Report Key: 17565025
• Report Number: 3023139607-2023-00001
• Device Sequence Number: 20497437
• Product Code: DQX
• UDI-Device Identifier: 04582105830103
• UDI-Public: (01)04582105830103(17)260228(10)230301R011
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/08/2023
• Report Date (Section F): 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: VGT14300HYB
• Device Lot Number: 230301R011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/24/2023
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2023
• 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: Unknown
• Date Report Sent to FDA: 08/17/2023