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

Catalog Number	VGT14300HYB
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: asahi intecc (thailand) co., ltd., pathum thani, thailand, registration number: 3003780911.[manufacturing records] we have confirmed that all products are passed the test and inspection.[lot history reviews] we have not received the similar complaints as wire broke off on the same lot.Instructions for use (ifu) states: [warnings]: 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 or Problem Description
Vassallo gt hybrid.014 ("the product") was used for the lesion with 250mm 100% stenosis moderate calcification.Antegrade femoral approach was attempted first with the product, unsuccessfully.While tibial / pedal approach was then attempted with the product, the distal end broke off inside the patient.The foreign object was able to be removed from the patient by balloon catheter.The product was used with a saber.014" balloon, 3.5mm x300 mm.
Additional Manufacturer Narrative
[manufacturing records] we have confirmed that all products are passed the test and inspection.[lot history reviews] we have not received the similar complaints as wire broke off on the same lot.[complaint history review] we have also confirmed that complaint trends for same structure products, (b)(6) and (b)(6) only distributed in japan, almost last 3 years does not show increasing trend of wire broken off.[returned product investigation] the reported vassallo gt hybrid.014 guide wire ("the product") was returned for evaluation.It is confirmed that the core wire is broken off approximatelly at 21mm from the distal tip and pt-ni coil wire is also broken off near the proximal welding part.Through magnified observation of the cracked surface of core wire and pt-ni coil wire with a scanning electron microscope, it is presumed that the core wire is broken off because of clockwise rotational manipulation and that the pt-ni coil wire is twisted with core wire because of rotational manipulation and gets streching force.Confirming each dimention of the distal part and magnified pictures of each part, it is presumed that there are no missing part of core wire and coil wire.It is confirmed that some part of polymer jacket and ptfe coating are peeled and damaged.Confirming provided information and investigation results of returned product, it is presumed that when crossing the lesion, middle-calcified, occlusion rate 100%, 250mm long, the distal part of the product is trapped with the lesion and the product is sequetially rotated in same direction, which makes the core broken off.It is presumed that rotating the product further more, pt-ni coil wire is twisted with core wire and that excessive stretching force makes coil wire broken off as well.It is presumed that some part of polymer jacket and ptfe coating are peeled and damaged because a torque device could be misused and a metalic device could scratch the surface of ptfe coating.As a result of reviewing manufacturing records and complaint history, abnormality and similar incidents are not identified.Therefore, it is presumed that this incident is attributed not to product quality but to the procedure at a moment.No action is taken nor is planned to be taken as instructions for use (ifu) states: [warnings] ~when torquing this guide wire inside the blood vessel, do not torque continuously in the same direction.This may cause the guide wire to become damaged or break apart, causing injury to the blood vessel or leaving fragments inside the vessel.When torquing the guide wire, rotate it clockwise and counterclockwise alternately.Do not exceed two rotations (720�¿) in the same direction.[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) although the initial importer has informed us that the distributor is going to send additional information about how the accessory device was used to us, we have not received it yet.After receiving additional information, we are going to submit follow-up report.
Event or Problem Description
Vassallo gt hybrid.014 ("the product") was used for the lesion with 250mm 100% stenosis moderate calcification.Antegrade femoral approach was attempted first with the product, unsuccessfully.Tibial / pedal approach was then attempted with the product.The product was used with a.018" support catheter, which is cook cxi or csi vipercross.The distal end of the product broke off while attempting to cross the lesion.The foreign object was retrieved with a ballon catheter.
Additional Manufacturer Narrative
It was reported by the initial importer that "the product was used with a.018" support catheter.It cannot be confirmed if the support catheter was cook cxi or csi vipercross.No balloon was used with this wire, as the wire broke while attempting to cross the lesion.The physician inserted a balloon catheter after the wire broke to retrieve it.".Although the result of investigation and conclusion are not changed, we made this report as a final report.[manufacturing records] we have confirmed that all products are passed the test and inspection.[lot history reviews] we have not received the similar complaints as wire broke off on the same lot.[complaint history review] we have also confirmed that complaint trends for same structure products, vgw1423ns3 and vgw1430ns3 only distributed in japan, almost last 3 years does not show increasing trend of wire broken off.[returned product investigation] the reported vassallo gt hybrid.014 guide wire ("the product") was returned for evaluation.It is confirmed that the core wire is broken off approximatelly at 21mm from the distal tip and pt-ni coil wire is also broken off near the proximal welding part.Through magnified observation of the cracked surface of core wire and pt-ni coil wire with a scanning electron microscope, it is presumed that the core wire is broken off because of clockwise rotational manipulation and that the pt-ni coil wire is twisted with core wire because of rotational manipulation and gets streching force.Confirming each dimention of the distal part and magnified pictures of each part, it is presumed that there are no missing part of core wire and coil wire.It is confirmed that some part of polymer jacket and ptfe coating are peeled and damaged.Confirming provided information and investigation results of returned product, it is presumed that when crossing the lesion, middle-calcified, occlusion rate 100%, 250mm long, the distal part of the product is trapped with the lesion and the product is sequetially rotated in same direction, which makes the core broken off.It is presumed that rotating the product further more, pt-ni coil wire is twisted with core wire and that excessive stretching force makes coil wire broken off as well.It is presumed that some part of polymer jacket and ptfe coating are peeled and damaged because a torque device could be misused and a metalic device could scratch the surface of ptfe coating.As a result of reviewing manufacturing records and complaint history, abnormality and similar incidents are not identified.Therefore, it is presumed that this incident is attributed not to product quality but to the procedure at a moment.No action is taken nor is planned to be taken as instructions for use (ifu) states: [warnings] when torquing this guide wire inside the blood vessel, do not torque continuously in the same direction.This may cause the guide wire to become damaged or break apart, causing injury to the blood vessel or leaving fragments inside the vessel.When torquing the guide wire, rotate it clockwise and counterclockwise alternately.Do not exceed two rotations (720�¿) in the same direction.[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
• Common Device Name: PERIPHERAL GUIDE WIRE
• 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, aichi 463-0 024; JA 463-0024
• Manufacturer Contact: eriko inuzuka ; 1703 wakita-cho; moriyama-ku; nagoya-shi, aichi 463-0-024 ; JA 463-0024
• MDR Report Key: 17571156
• Report Number: 3012223769-2023-00001
• Device Sequence Number: 12862019
• Product Code: DQX
• UDI-Device Identifier: 04582105830103
• UDI-Public: (01)04582105830103(17)260228(10)230301R011
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203529NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: VGT14300HYB
• Device Lot Number: 230301R011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 07/24/2023; 07/24/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 09/28/2023; 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown