MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. NON-ASAHI GUIDE WIRE; PTCA GUIDE WIRE

Catalog Number	AGH146000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: (b)(4).Device evaluation could not be performed because the affected device was not returned.Lot history review revealed no anomaly relating to the reported event from either lot.No other similar product experience report was received from either lot.Based on the obtained information and referring to known similar events, it was presumed that bending or torsional stress generated with repeated wire manipulation in attempts to cross the cto had likely caused the reported separation of the tip of the prowater guide wire.The applied stress would accumulate and therefore exceed the product design limit likely when the tip was being trapped in the lesion, fracturing the tip.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.[malfunction and adverse effects] separation of the guide wire.
Event or Problem Description
It was reported that the tip of an asahi prowater guide wire dislodged and remained in vasculature during a percutaneous coronary intervention to treat a chronic total occlusion in the left anterior descending artery (lad).The guide wire was used in attempts to cross the cto when its tip was lodged in the lesion and came unraveled at the tip.A tulip snare was used to retrieve the tip but the attempt was ended unsuccessfully.A stent was placed to compress the tip against the vessel wall to keep it from moving distally.There was no complication with the patient or procedure associated with this event.
Event or Problem Description
It was reported that the tip of an asahi prowater guide wire dislodged and remained in vasculature during a percutaneous coronary intervention to treat a chronic total occlusion in the left anterior descending artery (lad).The guide wire was used in attempts to cross the cto when its tip was lodged in the lesion and came unraveled at the tip.A tulip snare was used to retrieve the tip but the attempt was ended unsuccessfully.A stent was placed to compress the tip against the vessel wall to keep it from moving distally.There was no complication with the patient or procedure associated with this event.On august 2, additional information was obtained: the user facility confirmed that there was no other impacted wire for this case other than the returned guide wire which was non-asahi product.
Additional Manufacturer Narrative
Tip separation was confirmed on the returned guide wire.The proximal end of the returned guide wire was undulated unlike prowater or any of asahi products.The user facility confirmed that there was no other guide wire that had broken off during the procedure other than the returned non-asahi guide wire.It was concluded that the reported prowater had no involvement in this event.

• Brand Name: NON-ASAHI GUIDE WIRE
• 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: 12171656
• Report Number: 3003775027-2021-00131
• Device Sequence Number: 1631960
• Product Code: DQX
• UDI-Device Identifier: 04547327056120
• UDI-Public: (01)04547327056120(17)231231(10)210127A10A
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

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: 12/31/2023
• Device Catalogue Number: AGH146000
• Device Lot Number: 210127A10A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/12/2021
• 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: Required Intervention; Disability
• Patient Weight: 83