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

Catalog Number VGW1430FL0

Device Problem Peeled/Delaminated (1454)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/22/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturing site: asahi intecc (thailand) co., ltd., pathum thani, thailand, registration number: 3003780911 since the product was already discarded in the user facility, the product is not available for investigation.Lot history review revealed no abnormities relating to the reported event.No other similar product experience report was received from this lot.Also, reviewing complaint trends of same structure products( vgw1423fl0, vgw1430fl0) in last 3 years, it is confirmed that number of "damage of coating" is small and no increasing trend is shown.Based on provided information, it is presumed that the distal part of the product (approximately 5cm from tip) was heavily touched with the lesion or the tip of microcathter while using the product with the microcathter(asahi caravel mc) at the btk lesion, middle-calcified, tortuous, resulting in polymer jacket and/ or hydrophilic coating was peeled.However, specific causes of incident is not determined at this moment because returning product is not available and we are waiting for detailed information about situation when the incident occured from distributor.As a result of above investigation, it is concluded that this event is not attributed to product quality but to procedure.However, it is unable to rule out a possibility that some fragments of polymer jacket and/ or hydrophilic coating might remain in the patient's body.Instructions for use (ifu) states: [warnings] always advance and withdraw the guide wire slowly.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, we are going to submit follow-up report about investigation result.

Event Description

It was reported that vassallo gt.014 floppy (the product) was used in a case of below-the-knee (btk) lesion and occlusion rate 70%-100%, middle-calcified.The physician mentions that the procedure took long and coating material of the product was peeled while inserting and pulling out the product and/or a microcather, asahi caravel mc(non-filmecc product) several times.He/she also mentions that he/she sensed resistance between the microcather and the product.The procedure was completed with another lot product.There are no health hazards on the patient.

Manufacturer Narrative

Manufaturing site: asahi intecc (thailand) co., ltd., pathum thani, thailand, registration number: 3003780911.It was reported that it was difficult to get any additional information from the distributor such as detailed information when peeling of coating occured since submittig the initial report.This is a follow-up report to conclude the incident.Since the product was already discarded in the user facility, the product is not available for investigation.Lot history review revealed no abnormities relating to the reported event.No other similar product experience report was received from this lot.Also, reviewing complaint trends of same structure products( (b)(4)) in last 3 years, it is confirmed that number of "damage of coating" is small and no increasing trend is shown.Based on provided information, it is presumed that the distal part of the product (approximately 5cm from tip) was heavery touched with the lesion or the tip of microcathter while using the product with the microcathter(asahi caravel mc) at the btk lesion, middle-calcified, tortuous, resulting in polymer jacket and/ or hydrophilic coating was peeled.However, specific causes of incident is not determined because returing product is not available and it is difficult to get any additional information from the distributor.As a result of above investigation, it is concluded that this event is not attributed to product quality but to procedure.However, it is unable to rule out a possibility that some fragments of polymer jacket and/ or hydrophilic coating might remain in the patient's body.Instructions for use (ifu) states: [warnings] always advance and withdraw the guide wire slowly.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 GUIDEWIRE
• Manufacturer (Section D): FILMECC CO., LTD.; 1703 wakita-cho,; moriyama-ku; nagoya-shi, aichi 463-0 024; JA 463-0024
• Manufacturer (Section G): FILMECC CO., LTD.; 1703 wakita-cho; moriyama-ku; nagoya-shi, 463-0 024; JA 463-0024
• Manufacturer Contact: daisuke tooyama ; 1703 wakita-cho; moriyama-ku; nagoya-shi, aichi 463-0-024 ; JA 463-0024
• MDR Report Key: 17787006
• MDR Text Key: 323892025
• Report Number: 3012223769-2023-00003
• Device Sequence Number: 1
• Product Code: DQX
• 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,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VGW1430FL0
• Device Lot Number: 230327R051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2023
• 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