MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. MEISTER 16; PERIPHERAL GUIDE WIRE

Catalog Number AMS-165-1645R

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/17/2023

Event Type  Injury  

Event Description

It was reported that an asahi meister guide wire was used with a non-asahi microcatheter during a transcatheter arterial chemoembolization (tace) to treat the s4 segment of the hepatic artery.During vessel selection, the meister guide wire could not be manipulated as intended.Upon removal, the polymer jacket of the guide wire was found peeled.No additional action was taken against this event.The guide wire was then replaced to resume the procedure.The intended treatment was successfully completed.The patient was reportedly fine without problem after the procedure.

Manufacturer Narrative

Manufacturing site: asahi intecc hanoi co., ltd.Hanoi, vietnam, registration number: (b)(4).The reported meister guide wire was returned for evaluation.A relatively large curve was observed on the distal segment of the returned meister guide wire, which was likely a trace of shaping.The outermost polymer jacket was found torn at approximately 57mm from the tip.The outer coil was exposed distal to the torn end of the polymer jacket up to approximately 48mm from the tip.Proximal to the torn end of the polymer jacket, the outer coil was found loosened and the polymer jacket was found stretched and twisted due to tensile stress and accumulated torsion.Distal to the exposed outer coil, the proximal side of the torn end of the polymer jacket was found flipped over distally for approximately 30mm to form pleats as polymer jacket surface had coil grooves.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 investigation outcome, it was presumed that torsion and tensile stress generated with wire manipulation was locally accumulated on the tip of the meister guide wire likely when the movement of the wire tip was restricted by the anatomy, tearing the polymer jacket.Further applied tensile stress generated with removal then made the polymer jacket flip over distally from its torn end.It was concluded that this event was not attributed to product quality.Although no adverse patient effects occurred, it was unable to completely rule out a possibility that fragmented polymer jacket might be left in the patient because of the severity of damage.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.[malfunction and adverse effects] abrasion of the guide wire coating.

• Brand Name: MEISTER 16
• Type of Device: 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: lei sun ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 17478020
• MDR Text Key: 320586107
• Report Number: 3003775027-2023-00074
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 0454732712327
• UDI-Public: (01)0454732712327(17)250930(10)220929A23A
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/08/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AMS-165-1645R
• Device Lot Number: 220929A23A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2023
• Initial Date FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2022
• 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): Other