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

Catalog Number VGT1823FL0

Device Problem Peeled/Delaminated (1454)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/07/2023

Event Type  Injury  

Event Description

It was reported that vassallo gt.018 floppy (the product) was used in a case of a lesion in the iliac artery with moderate calcification, moderate tortuosity and occlusion rate was 100%.When the knuckle wire technique was applied, the polymer jacket of the product peeled off during the procedure.The procedure was completed using another product of the same type of the product and there were no health hazard on the patient.

Manufacturer Narrative

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 (vgt1823fl0,vgt1830fl0) over the recent years showed that the number of events of polymer jacket 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.Based on the information obtained, it was presumed that when the product was being operated with a penetration device (elitecross) in an iliac artery with moderate calcification and moderate tortuosity, and its occlusion rate was 100%, the polymer jacket of the product has been damaged and detached due to strong contact with the combined device or the hardened lesion.However, the product has not been returned, and additional information has not been received yet from the distributor regarding the details of when the peeling occurred, and the specific cause of the occurrence has not yet been identified.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] 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) after receiving additional information, filmecc is going to submit follow-up report about investigation result.

Manufacturer Narrative

After submittig the initial report, filmecc received the information on january 5th from the distributor that it was impossible to get any additional information such as detailed information when polymer jacket peeling occured.This is a follow-up report to conclude the incident.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] although one similar complaint (polymer jacket peeling) was received for the same lot, after investigation, it was determined that the event was caused by excessive loading during the procedure.[complaint history review] complaints about products of the same structure (vgt1823fl0,vgt1830fl0) over the recent years showed that the number of events of polymer jacket 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.Based on the information obtained, it was presumed that when the product was being operated with a penetration device (elitecross) in an iliac artery with moderate calcification and moderate tortuosity, and its occlusion rate was 100%, the polymer jacket of the product has been damaged and detached due to strong contact with the combined device or the hardened lesion.However, specific causes of the incident was not determined because returing product was not available and it was impossible to get any additional information from the distributor.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] 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: 18390613
• MDR Text Key: 331294914
• Report Number: 3012223769-2023-00035
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K213949NA
• 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,Followup
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: VGT1823FL0
• Device Lot Number: 220330R011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2022
• 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): Required Intervention; Other