MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. GAIA PV; PERIPHERAL GUIDE WIRE

Catalog Number	PHW18R302P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site: asahi intecc (thailand) co., ltd.The reported gaia pv guide wire was returned for evaluation.Elongation of the outer coil and fracture of the core were confirmed on the returned guide wire.The outer coil was elongated for approximately 51cm from the mid solder that was originally located at 55mm from the tip.The ball tip on the very distal end of the elongated outer coil was found intact.The outer coil remained in one piece.The core wire was fractured at approximately 50mm distal to the mid solder.Twisting caused by accumulated torsion and bending were observed proximal to the fracture end of the core wire.On the distal side of the returned guide wire, a bend was also observed.The core fracture end was located at approximately 5mm from the tip.Distal to the fracture end, twisting and bending as seen on the proximal side of the fracture were confirmed.At approximately 11mm proximal to the tip, the end of the inner coil was exposed.Soldering material was attached at the exposed end of the inner coil, indicating that the inner coil remained in one piece.As fracture of the coil was not confirmed and measurement of the core length was in accordance with the product specification, it was concluded that the entire guide wire was returned.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 torquing wire manipulation in attempts to cross had most likely contributed to the observed core fracture.The applied stress would localize and therefore exceed the product design limit when the tip was being caught and restricted its movement by the lesion and thus it made the core to fracture.Tensile stress generated with removal then made the outer coil to elongate and the inner coil to detach from the solder jointed onto the core.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 effect]: breakage of the guide wire.
Event or Problem Description
It was reported that an asahi gaia pv guide wire was used for a percutaneous peripheral intervention to treat a moderately tortuous, moderately calcified, 75-90% stenosis in the unspecified limb artery.During the procedure, the wire seemed "trapped." when attempting to remove and release the trapped wire, the wire began to unravel.The wire was able to be removed without any pieces being lost.There was no adverse reaction to the patient.The patient was fine after the procedure.

• Brand Name: GAIA PV
• Common Device Name: PERIPHERAL 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: 15841180
• Report Number: 3003775027-2022-00154
• Device Sequence Number: 5994263
• Product Code: DQX
• UDI-Device Identifier: 04547327106917
• UDI-Public: (01)04547327106917(17)221231(10)200118A461
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K163426
• 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): 11/22/2022

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: 12/31/2022
• Device Catalogue Number: PHW18R302P
• Device Lot Number: 200118A461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2020
• 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
• Patient Sex: Unknown