MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE

Catalog Number	PAGH18M371
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing this complaint, attempts were made to obtain complete event information.The device analysis could not be conducted as the device was unavailable.Lot history review revealed no anomaly relating to the reported event and no other similar product experience report was received.Based on the obtained information, it was presumed that rotational force was continuously applied during wire manipulation with the guidewire controller while the distal segment of the guidewire was being trapped by the lesion.And when the force exceeded the product's design limit, the guidewire broke; however, details could not be identified.The result of lot history review showed there was no indication of product deficiency.Ifu states: [warnings] never push, auger, withdraw, or torque a guidewire that meets the resistance.Torquing or pushing a guidewire against resistance may cause guidewire damage and/or guidewire tip separation or direct damage to a vessel.Resistance may be felt and/or observed under fluoroscopy by noting any bucking of the guidewire tip.If guidewire tip prolapse is observed, do not allow the tip to remain in a prolapsed position; otherwise damage to the guidewire may occur.Determine the cause of resistance under fluoroscopy and take any necessary remedial action; [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] when torquing the guidewire inside the blood vessel, do not torque continuously in the same direction.This may cause the guidewire to become damaged or break apart, causing injury to the blood vessel or leaving fragments inside the vessel.When torquing the guidewire, rotate it clockwise and counterclockwise alternately.Do not exceed two rotations (720 degrees) in the same direction; and, [malfunction and adverse effects] separation or breakage of the guide wire.
Event or Problem Description
It was reported that during a percutaneous peripheral intervention to treat a mildly tortuous lesion in the proximal-mid superficial femoral artery, an asahi guidewire was used with a non-asahi guidewire controller and broke in the vasculature.The guidewire was successfully removed.No health impact on the patient was reported.

• Brand Name: ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE
• Common Device Name: PERIPHERAL GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, 489-0 071; JA 489-0071
• MDR Report Key: 6589929
• Report Number: 3003775027-2017-00083
• Device Sequence Number: 19058876
• Product Code: DQX
• UDI-Device Identifier: 04547327088299
• UDI-Public: (01)04547327088299(17)191031(10)161111A121
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K071721
• 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): 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: PAGH18M371
• Device Lot Number: 161111A121
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2017
• Initial Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR