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

Catalog Number VGW1423FL0

Device Problem Peeled/Delaminated (1454)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/31/2021

Event Type  Injury  

Event Description

It was reported that vassallo gt.014 floppy (the product) was used in a case of a lesion in the below-knee area with moderate tortuosity and moderate calcification, and occlusion rate of 70% to less than 100%.After using the product for a long time, the polymer jacket peeled off.There were no health hazard on the patient.

Manufacturer Narrative

Filmecc is conducting a retrospective review of world-wide complaints received after 510(k) clearance but prior to commercial release in the united states.This mdr is being filed based on the outcome of that retrospective review.A capa has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.Manufacturing site: asahi intecc (thailand) co., ltd., pathum thani, thailand, registration number: 3003780911.[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 (vgw1423fl0, vgw1430fl0) over the past three years showed that the number of events of peeling of polymer jacket 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.Based on the information that the polymer jacket peeled off after prolonged use and that the combination device was not used, it was presumed that the polymer jacket of the product came into strong contact with a moderate calcification during the process of attempting to pass through the lesion, causing damage to the polymer jacket and resulting in its peeling off.As a result of above investigation, although it was concluded that this event was not attributable to the product quality but to the procedure, 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]: ~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.~do not push the guide wire more than necessary to advance the tip through the narrowed part of the vessel.(for example, do not push the guide wire when the distal tip of the guide wire is bent by the force of manipulation.) after crossing the targeted area, do not roughly twist, push or pull the guide wire.If the guide wire is moved excessively, it may be damaged or break apart, which may injure the blood vessel or leave fragments inside the vessel.[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).

• 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.; 1703 wakita-cho; moriyama-ku; nagoya, aichi 463-0 024; JA 463-0024
• Manufacturer Contact: eriko inuzuka ; 1703 wakita-cho; moriyama-ku; nagoya, aichi 463-0-024 ; JA 463-0024
• MDR Report Key: 18108815
• MDR Text Key: 327887141
• Report Number: 3012223769-2023-00011
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04562102681007
• UDI-Public: (01)04562102681007(17)230331(10)200409R011
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K203533NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: VGW1423FL0
• Device Lot Number: 200409R011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2020
• 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