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

Catalog Number	AGP140002
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Single reporter exemption #e2015028.Device evaluation could not be performed because the 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 obtained information, it was concluded that the edge of the metal tuohy needle scraped the wire surface and peeled the ptfe coating.There was no indication of product deficiency.Although there were reportedly no adverse patient effects, a possibility could not be completely ruled out that some ptfe coating fragments might have entered into the vasculature.Instructions for use (ifu) states: [warnings] never use metallic needles or metallic sheaths for insertion and withdrawal of this guide wire.Otherwise, the surface of this guide wire may be damaged significantly; and, [malfunction and adverse effects] abrasion of the guide wire coating.
Event or Problem Description
It was reported that the procedure was to treat a chronic totally occluded circumflex coronary artery.The asahi guide wire was advanced to the target lesion, but during torqueing of the guide wire, there was teflon flaking on the proximal end of the guide wire next to the tuohy.The flaking of teflon was outside the patient anatomy.However, it was decided to remove the guide wire.The guide wire was removed without any issue.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.It was then decided to have the patient sent for coronary artery bypass (cabg) due to having multi-vessel disease, but not related to the guide wire used or the procedure.
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 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: 8229701
• Report Number: 3003775027-2019-00001
• Device Sequence Number: 13959841
• Product Code: DQX
• UDI-Device Identifier: 04547327072854
• UDI-Public: (01)04547327072854(17)210131(10)180208A391
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/19/2018

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: AGP140002
• Device Lot Number: 180208A391
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/19/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 12/23/2019
• 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
• Patient Age: 78 YR
• Patient Weight: 84