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

Catalog Number	VGT14300XSP
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Vassallo gt.014" ("the product") was used with the auryon atherectomy catheter in the patient's body, and it was very sticky and tight when removing auryon.Green flaking appeared when wet telfa wiped the product.The procedure was completed by switching to a different wire and there was no health hazard on the patient's body.
Event or Problem Description
Vassallo gt.014" ("the product") was used with the auryon atherectomy catheter in the patient's body, and it was very sticky and tight when removing auryon.Green flaking appeared when wet telfa wiped the product.The procedure was completed by switching to a different wire and there was no health hazard on the patient's body.

• Brand Name: VASSALLO GT
• Common Device Name: PERIPHERAL 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: 18849561
• Report Number: 3023139607-2024-00002
• Device Sequence Number: 7438830
• Product Code: DQX
• UDI-Device Identifier: 04582105830080
• UDI-Public: (01)04582105830080(17)260430(10)230523R011
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Followup
• Report Date (Section B): 03/04/2024
• Report Date (Section F): 03/06/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: VGT14300XSP
• Device Lot Number: 230523R011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/08/2024
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 03/06/2024
• 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: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/06/2024