MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. FIELDER XT; PTCA GUIDE WIRE

Catalog Number AGP140002

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/20/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturing site: manufacturing site could not be identified because the product lot number information was not available.Device evaluation could not be performed because the affected device was not returned.Lot history records review could not be conducted because lot information was unavailable.All the shipped products were inspected in the production process and satisfied the product specifications and release criteria; therefore, it was concluded that there was no anomaly in product quality.Based on the obtained information and referring to known similar event, it was presumed that tensile stress exceeding the product design limit might have been applied on the tip of the fielder xt guide wire during wire removal while the wire tip was trapped between the deployed stent and the vessel wall.Consequently, the wire tip was detached.It was concluded that this event was not attributed to product quality.No capa will be taken.Instructions for use (ifu) states: [warnings] observe movement of this guide wire in the vessels.Before this guide wire is moved or torqued, the tip movement should be examined and monitored under fluoroscopy.Do not move or torque the guide wire without observing corresponding movement of the tip; otherwise, the guide wire may be damaged and/or trauma may occur.In addition, ensure that the distal tip of this guide wire and its location in the vessel are visible during manipulations of the guide wire.Never push, auger, withdraw, or torque this guide wire that meets resistance.Torquing or pushing this guide wire against resistance may cause damage and/or tip separation of this guide wire or direct damage to a vessel.Resistance may be felt and/or observed under fluoroscopy by noting any buckling of the guide wire.If the prolapse of the guide wire tip 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.If resistance is felt due to spasm, bending of the guide wire, or due to trap while operating this guide wire in the blood vessel or removing it, do not torque and/or pull the guide wire itself.Stop the procedure.Determine the cause of resistance under fluoroscopy and take appropriate remedial action.If the guide wire is moved excessively, it may break or become damaged, which may cause blood vessel injury or result in fragments being left inside the vessel.Do not perform stent placement using more than one guide wire or wire operation through stent strut.Otherwise, the stent may be damaged or the guide wire may break or break apart.[malfunction and adverse effects] separation of the guide wire.

Event Description

It was reported that a percutaneous coronary intervention (pci) was performed to treat a heavily calcified lesion in the left main trunk (lmt), left anterior descending artery (lad) and the left circumflex artery (lcx).After stent deployment in the lmt, the physician attempted to rewire the lcx to complete bifurcation stenting.An asahi fielder xt guide wire was delivered, but went behind the stent.During removal of the fielder xt guide wire, the distal segment uncoiled and was stuck under the stent in the lmt.The wire tip was detached.Several attempts were made to remove the wire fragment, but were unsuccessful.It was informed that the patient was good after the procedure.No further information was available.

Event Description

It was reported that a percutaneous coronary intervention (pci) was performed to treat a heavily calcified bifurcation lesion between the left main trunk (lmt) and the left circumflex artery (lcx).After stent deployment in the lmt, the physician attempted to rewire the lcx to complete bifurcation stenting.An asahi fielder xt guide wire was delivered, but went behind the stent.During removal of the fielder xt guide wire, the distal segment uncoiled and was stuck under the stent in the lmt.The wire tip was detached.Several attempts were made to remove the wire fragment, but were unsuccessful.A stent was then deployed to embed the fragment.The procedure was completed.It was informed that the patient was good after the procedure.No further information was available.

• Brand Name: FIELDER XT
• Type of Device: PTCA GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer (Section G): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer Contact: lei sun ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 19122970
• MDR Text Key: 340339916
• Report Number: 3003775027-2024-00047
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AGP140002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: No
• 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; Disability
• Patient Sex: Female