MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. ASAHI FIELDER XT; PTCA GUIDE WIRE

Catalog Number	AGP140302
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Single reporter exemption #e2015028.The importer report number used for this report was generated from the importer registration number, current year, and sequential number that match the manufacturer report number.The guide wire was returned for evaluation.The distal segment of the returned guide wire was helically deformed originating approximately 130mm distal to the proximal solder.Elongation of the coil wire and the polymer jacket was observed on the deformed segment.The core wire was exposed and found fractured at approximately 155mm distal to the proximal solder.Microscopic observation of the fracture ends revealed that the core wire was necked.This indicated the core wire fracture was due to tensile stress.The coil wire had a flat fracture surface that suggested twisting stress was generated as coils got straightened.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received from this lot.Reviewing of production records found no indication of product deficiency.It was concluded that tensile stress exceeding the product's design limit was inadvertently applied while the wire was being trapped possibly by the lesion.That excess stress was assumed to have contributed to the reported wire breakage.Although it was reported there were no adverse patient effects, the separated segment was not returned and damage of the polymer jacket was severe; therefore, it was concluded that a possibility that some fragments might be left in the anatomy could not be completely ruled out.Instructions for use (ifu) states: [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 or breakage of the guide wire.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the superficial femoral artery.The guide wire was advanced to the target lesion but failed to cross due to the patient anatomy.When the guide wire was removed, and it was noted that the coils appears separated and unraveled at the tip of the wire but were still in one piece.A new guide wire was used to complete the procedure.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.The final patient outcome was good.No additional information can be provided as the physician and procedure log have no additional information on what occurred to the guide wire.
Additional Manufacturer Narrative
Asahi intecc has determined that the date recorded in date of this report was erroneously reported as the date the report was submitted rather than the date the initial reporter provided the information about the event to the company.Corrective action has been taken to clarify which date should be provided in the report.This supplemental report is intended only to correct the date provided in to reflect the date the initial reporter provided the information about the event to the company.

• Brand Name: ASAHI FIELDER XT
• 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: 8182744
• Report Number: 3003775027-2018-00216
• Device Sequence Number: 11241648
• Product Code: DQX
• UDI-Device Identifier: 04547327072861
• UDI-Public: (01)04547327072861(17)210131(0)180203A211
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K072431
• 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,Followup
• Report Date (Section B): 12/05/2018

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: 01/31/2021
• Device Catalogue Number: AGP140302
• Device Lot Number: 180203A211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/05/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 12/20/2019
• 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: Other