MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. GAIA SECOND; PTCA GUIDE WIRE

Catalog Number	AHW14R008P
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip of an asahi gaia second had broken off at hinge point in the subintimal layer of the right coronary artery (rca) during a percutaneous coronary intervention (pci) to treat a chronic total occlusion (cto) with mild calcification in the rca.The rest of the wire was removed cleanly from the coronary.No attempt was made to retrieve the wire fragment and it was left in the subintimal layer.Procedure was ended.The procedure was not successful.He decided to end the procedure and he took the patient off the table very shortly after the wire fracture.At that point, the patient was stable and there was no impact to the patient.Physician stated it was because he "over manipulated the wire" and he "did not remove it when it was beginning to fatigue.".
Additional Manufacturer Narrative
Manufacturing site: (b)(4).Device evaluation could not be performed because the affected device was discarded by the user facility.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received from this lot.Based on the provided information and investigation outcome, it was presumed that torsion and/or bending stress generated with torquing and pushing wire manipulation in attempts to cross had likely contributed to the reported wire fracture.The applied stress would localize and therefore exceed the product design limit when the tip was being caught and restricted its movement in the subintimal layer.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.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 degrees) in the same direction.[malfunction and adverse effects] separation of the guide wire.

• Brand Name: GAIA SECOND
• Common Device Name: 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: yukako homma ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 15867187
• Report Number: 3003775027-2022-00155
• Device Sequence Number: 5126562
• Product Code: DQX
• UDI-Device Identifier: 04547327094702
• UDI-Public: (01)04547327094702(17)250531(10)220615A501
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K171933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/28/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Catalogue Number: AHW14R008P
• Device Lot Number: 220615A501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 11/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• 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: Disability
• Patient Age: 55 YR
• Patient Sex: Male