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

Catalog Number	AHW14R008P
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: asahi intecc (b)(4) registration number: (b)(4).The gaia second guide wire was returned for evaluation without its separated tip.The spring coil of the guide wire was fractured and elongated for approximately 93cm from the proximal solder that was originally located at 150mm proximal to the tip.At approximately 125mm from the tip, the core was found fractured.Microscopic observation found that the core was severely twisted accompanied with multiple cracks.The fracture end of the elongated coil was also twisted, attributing to torsion that was generated as the coil got unwound.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 generated in attempts to cross the distal cap of the isr cto most likely had contributed to the observe fracture on the returned gaia second guide wire.The applied stress would localize and exceed the product design limit likely when the tip was being caught and restricted its movement by the lesion, making the spring coil become unraveled and entrapped the tip of the concomitant microcatheter.Further applied rotations on the guide wire then made the core wrench off.Stress associated with removal made the spring coil become elongated and fractured, eventually detaching the tip.It was conclude that this event was not attributed to product quality.Because the retrieved tip was not returned, a possibility remained that some portion of it might be left in the patient.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.If resistance is felt between this guide wire and the other interventional devices while operating this guide wire in the blood vessel, avoid applying excessive force.When abnormal resistance is felt, remove the entire system from the patient's body and determine the cause.Otherwise, the guide wire may break or be damaged and may cause injury to the blood vessel or leave fragments 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 or breakage of the guide wire.
Event or Problem Description
It was reported that the tip of an asahi gaia second guide wire detached during a percutaneous coronary intervention (pci) to treat a chronic total occlusion secondary to in-stent restenosis (isr cto) in the mid right coronary artery (rca).An asahi gaia second guide wire was used to navigate through the isr cto.When the wire reached the distal cap, the wire was torqued multiple times to advance down the distal vasculature but the tip would not respond.When retracting the wire, the core of the wire came out but the tip did not retract with the wire.Spring coil was attached to the concomitant mamba microcatheter.Catheter and wire tip were removed together.No fragments left behind.Cto intervention was not successful but patient recovered well and was discharged home later in the evening.The physician commented that with all the torqueing somehow the wire got trapped on the end of the microcatheter.

• 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
• MDR Report Key: 11336417
• Report Number: 3003775027-2021-00033
• Device Sequence Number: 19966421
• Product Code: DQX
• UDI-Device Identifier: 04547327094702
• UDI-Public: (01)04547327094702(17)230331(10)200401X021
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2021

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: 03/31/2023
• Device Catalogue Number: AHW14R008P
• Device Lot Number: 200401X021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other