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

Catalog Number VGW1430NS3

Device Problem Peeled/Delaminated (1454)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/16/2021

Event Type  Injury  

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:(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 (vgw1423ns1,vgw1430ns1,vgw1423ns3,vgw1430ns3) 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] the coil was deformed at approximately 22 mm from the tip of the product and the polymer jacket was damaged at approximately 90 mm from the tip.In addition, polymer jacket was damaged at approximately 345 mm from the tip.Based on the condition of the product and information obtained, it was presumed that the damage and peeling of the polymer jacket of the product were caused by the edge of the metal tip of the combined penetration catheter,etc.Coming into strong contact with the surface of the product when the penetration catheter,etc.With the metal tip were advanced along the product and excessive load was applied, resulting in damage to the polymer jacket and the peeling.The deformation of the coil at approximately 22 mm from the tip was presumed to have been caused by loading in the process of passing through the lesion with moderate calcification and 100% occlusion.As a result of above investigation, although it was concluded that this event was not attributable to 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]: ~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.~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).

Event Description

It was reported that vassallo gt.014 ns3 (the product) was used in a case of a lesion in the superficial femoral artery to below-knee area with moderate tortuosity and severe calcification, and occlusion rate of 100%.When a penetration catheter and micro catheter, etc.(details unknown) were used along the product, the polymer jacket of the product peeled off within a range of approximately 15 cm to 30 cm from the tip.There were no health hazard on the patient.

• 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: 18108614
• MDR Text Key: 327868661
• Report Number: 3012223769-2023-00008
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04562102690023
• UDI-Public: (01)04562102690023(17)240331(10)210419R021
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K203529NA
• 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: 03/31/2024
• Device Catalogue Number: VGW1430NS3
• Device Lot Number: 210419R021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2021
• 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