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

Catalog Number	AHW14R008P
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device investigation could not be performed because the device was not returned.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received for this lot.Based on the provided information and findings on records review, it was presumed that tensile stress generated with wire removal had most likely contributed to the reported wire separation.The generated stress would exceed the product design limit when the wire tip was being caught and restricted its movement by the existing stent.It was concluded that this event was not attributed to product quality.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; [warnings] 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; and, [malfunction and adverse effects] separation of the guide wire.
Event or Problem Description
It was reported that the tip of an asahi gaia second guide wire separated during a pci to treat a cto (in-stent restenosis) in the mid rca.While the physician was attempting to wire the vessel, the wire appeared to get stuck behind an existing stent.He pulled the wire back, but the distal portion of the wire broke up and remained stuck in the stent and in the body.The remainder of the wire was removed and several attempts to snare the remainder of the wire were unsuccessful.The procedure was aborted after multiple failed snare attempts.The patient was released from the hospital doing well and planned for bypass surgery.

• Brand Name: ASAHI 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: 9851808
• Report Number: 3003775027-2020-00057
• Device Sequence Number: 16977278
• Product Code: DQX
• UDI-Device Identifier: 04547327094702
• UDI-Public: (01)04547327094702(17)220131(10)190211A211
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/06/2020

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: 01/31/2022
• Device Catalogue Number: AHW14R008P
• Device Lot Number: 190211A211
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 03/19/2020
• 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: Required Intervention; Disability