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

Catalog Number VGT14300XSP

Device Problem Peeled/Delaminated (1454)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/31/2024

Event Type  Injury  

Event 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 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
• Type of Device: 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
• MDR Text Key: 337035814
• Report Number: 3023139607-2024-00002
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04582105830080
• UDI-Public: (01)04582105830080(17)260430(10)230523R011
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2024,03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Report Sent to FDA: 03/06/2024
• Distributor Facility Aware Date: 02/08/2024
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other