MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. ASAHI CONFIANZA PRO 12; PTCA GUIDE WIRE

Catalog Number	AGH143391
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	11/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: asahi intecc (b)(4).The received information was too scares to identify the user facility and no further information could be obtained.It was concluded that the reported guide wire was highly likely separated in the lesion.Although it was reported that there were no apparent harm to the patient, a possibility could not be completely ruled out that some wire fragment might be left in the anatomy as no information regarding remedial actions was obtained and the guide wire was not returned.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.Device evaluation of the subject guide wire could not be performed because the device was discarded by the user facility.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 presumed that torsional and/or 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.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; [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; and, [malfunction and adverse effects] separation or breakage of the guide wire.
Event or Problem Description
Sus voluntary event report (report number: mw5081406) was received from the importer.It was reported as follows: patient underwent angiography of both legs during procedure a small fragment of the chronic total occlusion wire was broken in the right sfa.No apparent harm.
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 date of report to reflect the date the initial reporter provided the information about the event to the company.

• Brand Name: ASAHI CONFIANZA PRO 12
• 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: 8158515
• Report Number: 3003775027-2018-00215
• Device Sequence Number: 1664881
• Product Code: DQX
• UDI-Device Identifier: 04547327058162
• UDI-Public: (01)04547327058162(17)210430(10)180512A051
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2018
• Report Date (Section F): 12/01/2018

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: 04/30/2021
• Device Catalogue Number: AGH143391
• Device Lot Number: 180512A051
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2018
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 12/12/2018
• 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