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
Additional Manufacturer Narrative
Manufacturing site: asahi intecc (thailand) co., ltd., pathum thani, thailand, registration number: (b)(4).[manufacturing records] all products were confirmed to have passed inspection.[lot history review] no other similar product experience report was received from this lot.[complaint history review] complaints about products of the same structure (vgw1419sp0,vgw1430sp0) distributed in japan, over the past three years showed that the number of events of coating peeling was small and did not show an increasing trend.[returned product investigation] since the product was already discarded in the user facility, the product was not available for the investigation.The ifu warnings for this product states "do not use the guide wire in combination with catheters (atherectomy catheter, metallic dilator etc.) which may result in unintended adverse events requiring additional intervention.]" but we have received information that the product was used in combination with an atherectomy catheter which has metal tip, and therefore, we conclude that the event was occurred when metal part of the atherectomy catheter, which is a contraindicated device, came into contact with the coating of the product, causing resistance and resulting in coating peeling of the product.Since there are no problems in the manufacturing/inspection records, and since there is no trend indicating an increase in the number of similar events, it was concluded that this event was not attributable to product quality but to the procedure.However, we cannot completely rule out the possibility that detached pieces were left behind in the patient's body.Instructions for use (ifu) states below and no capa will be taken.[warnings]: do not use the guide wire in combination with catheters (atherectomy catheter, metallic dilator etc.) which metallic part may contact surface of this guide wire.[manipulation, advancement, and/or withdrawal through a metal device may result in destruction and/or separation of the outer coating, resulting in coating material remaining in the vasculature, which may result in unintended adverse events requiring additional intervention.] never push, auger, withdraw, or torque a guide wire that meets resistance.Torquing or pushing a guide wire against resistance may cause guide wire damage and/or guide wire tip separation or direct damage to a vessel.Resistance may be felt and/or observed under fluoroscopy by noting any buckling of the guide wire tip.If guide wire tip prolapse is observed, do not allow the tip to remain in a prolapsed position.[otherwise damage to the guide wire may occur.] determine the cause of resistance under fluoroscopy and take any necessary remedial action.[malfunction and adverse effects]: possible complications and adverse events of guide wire use include, but are not limited to: damage of guidewire (separation, breakage, damage of coating).
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, aichi 463-0 024; JA 463-0024
• Manufacturer (Section G): FILMECC CO., LTD.; 1730 wakita-cho; moriyama-ku; nagoya, aichi 463-0 024; JA 463-0024
• Manufacturer Contact: eriko inuzuka ; 1730 wakita-cho; moriyama-ku; nagoya, aichi 463-0-024 ; JA 463-0024
• MDR Report Key: 18813446
• Report Number: 3012223769-2024-00003
• Device Sequence Number: 18185108
• 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
• PMA/510(K) Number: K203533NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2024
• Initial Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown