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

Catalog Number AHW14R011P

Device Problem Insufficient Information (3190)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 12/19/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturing site: (b)(4), registration number: (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.Given information inferred the guide wire was used in a complex lesion.Referring to known similar events, it was presumed that patient anatomy and procedural context were most likely associated with the reported suspicious vessel damage that was thought to trigger hypotension.It was concluded that this event was not related to product quality.No capa will be taken.Instructions for use (ifu) states: 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.Use this guide wire carefully as the guide wire may penetrate the blood vessel.Otherwise, it may cause adverse events such as blood vessel perforation and coronary artery dissection.The higher torque performance, stiffer distal end, and/or higher advancement force may present a higher risk of perforation or injury than if using a more flexible guide wire.Therefore, use the most flexible guide wire that will treat the lesion (i.E., the guide wire with the smallest tip load that will treat the lesion), and take due care to minimize the risk of perforation or other damage to blood vessels.[malfunction and adverse effects].Damage to a vessel, including possible vessel perforation.

Event Description

It was reported that an asahi gaia third guide wire was used in a percutaneous coronary intervention (pci) to treat a chronic occlusion in the left anterior descending artery (lad).The operator used multiple working guide wires and gradually upgraded the hardness of the guide wire.Finally, gaia third guide wire was used to try to pass through the lesion.The patient subsequently developed transient hypotension, which was suspected to be pericardial tamponade.Hypotension was treated with application of atropine and amines.The patient's heart rate and blood pressure recovered.It was suspected that the guide wire caused coronary artery damage during the process of passing through the lesion and echocardiography was performed.No additional information was provided.

• Brand Name: GAIA THIRD
• 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: yukako homma ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 16127735
• MDR Text Key: 306982938
• Report Number: 3003775027-2023-00001
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04547327105996
• UDI-Public: (01)04547327105996(17)250531(10)220525A50A
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 01/10/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: AHW14R011P
• Device Lot Number: 220525A50A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2022
• 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
• Patient Age: 50 YR
• Patient Sex: Male