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

Catalog Number	AHW14R011P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site: (b)(6).The gaia third guide wire was returned for evaluation.The coil of the returned guide wire was loosened, and detached from the tip solder.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 with wire manipulation had most likely contributed to the observed coil detachment.The applied torque would localize, and exceed the product design limit when the tip of the guide wire was caught, and restricted its movement by the complex lesion.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; warning: if any resistance is felt due to spasm or the guidewire being bent or trapped while operating the guidewire in the blood vessel or removing it, do not move or torque the guidewire.Stop the procedure.Determine the cause of resistance under fluoroscopy and take appropriate remedial action.If the guidewire is moved excessively, it may break or become damaged, which may cause blood vessel injury or result in fragments being left inside the vessel; warning: when torquing the guidewire inside the blood vessel, do not torque continuously in the same direction.This may cause the guidewire to become damaged or break apart, causing injury to the blood vessel or leaving fragments inside the vessel.When torquing the guidewire, rotate it clockwise and counterclockwise alternately.Do not exceed two rotations (720°) in the same direction; and, 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 third guide wire broke during a pci to treat a heavily calcified cto at the saphenous vein graft to the lad.The guide wire was being used to cross the lesion when the tip broke.All the wire came out of the vessel as it was felt like the spring coil held the tip of the wire during removal.The procedure was continued with several other non-asahi products;,however, none of them was able to cross the blockage.The patient was stable without known adverse effects associated with this event.

• Brand Name: GAIA THIRD
• 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: 10551859
• Report Number: 3003775027-2020-00145
• Device Sequence Number: 19637367
• Product Code: DQX
• UDI-Device Identifier: 04547327094788
• UDI-Public: (01)04547327094788(17)230131(10)200221A051
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: AHW14R011P
• Device Lot Number: 200221A051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR