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  

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 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, 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
• MDR Text Key: 336617373
• Report Number: 3012223769-2024-00003
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203533NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• 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
• Date Manufacturer Received: 02/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other