MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. SION BLUE; PTCA GUIDE WIRE

Catalog Number	AHW14R004J
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: (b)(4), registration number: (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.No other similar product experience report was received from this lot.Based on the provided information and referring to known similar events, it was presumed that repeated bending stress had likely contributed to the reported separation of the guide wire.The tip of the guide wire was suspected to be trapped and restricted its movement likely by the existing stent or calcium at the time of ivus delivery with difficulty.Given the situation, the applied stress would localize and exceed the product design limit and therefore the guide wire became fractured.The second wire fragment was likely caused by tensile stress generated as attempts were made to retrieve the fractured guide wire.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.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 sion blue guide wire had separated during a pci to treat an in-stent restenosis in the rca.The existing stent was long and placed just distal to the ostium through just proximal to the pl.No issues getting through the calcium and tortuosity.Ivus was loaded on the guide wire to investigate rca ostium with 360 calcification.Ivus would not cross.Upon trying to advance ivus, it was noticed that the guide wire had separated into the distal pl.Various attempts were made to retrieve the wire fragments.Upon removing the wire, it was observed that a second fragment was left behind in the distal rca.The decision was made not to re-intervene due to exposure and contrast loads from day of the procedure.The patient is stable and kept for observation.Any further information was not provided by the user facility.

• Brand Name: SION BLUE
• 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: 12458168
• Report Number: 3003775027-2021-00162
• Device Sequence Number: 4067387
• Product Code: DQX
• UDI-Device Identifier: 04547327086240
• UDI-Public: (01)04547327086240(17)230731(10)200808A07A
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K191464
• 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): 09/13/2021

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: 07/31/2023
• Device Catalogue Number: AHW14R004J
• Device Lot Number: 200808A07A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 09/13/2021
• 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: Disability
• Patient Age: 79 YR