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

Catalog Number AGH146000

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Device Embedded In Tissue or Plaque (3165)

Event Date 12/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Single reporter exemption (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.Device investigation 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 pushing, tensional, and/or torsional stress generated during wire manipulation in attempts to cross the severely calcified in-stent restenosis caused the distal segment of the guide wire to become coiled up and therefore trapped in the lesion.Wire manipulation was assumed to be continuously applied while the wire movement was restricted by calcification.That excess stress was assumed to have contributed to the reported wire fracture.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 Description

It was reported that the procedure was to treat in-stent restenosis in the heavily calcified proximal left anterior descending coronary artery.An asahi guide wire was advanced with resistance noted with the patient anatomy and the guide wire separated at the junction.The proximal portion of the separated guide wire was simply withdrawn from the patient anatomy.The distal portion coiled into a ball and a balloon dilatation catheter (bdc) was used to crush the guide wire into the vessel wall.A stent was then deployed to hold the guide wire in place against the vessel wall.Another stent was placed to treat the target lesion.The patient experienced no adverse sequela and there was no reported clinically significant delay in the procedure.No additional information was provided.

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 PROWATER
• Type of Device: 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: 8182722
• MDR Text Key: 130987057
• Report Number: 3003775027-2018-00217
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04547327056120
• UDI-Public: (01)04547327056120(17)210430(10)180509A25A
• Combination Product (y/n): N
• PMA/PMN Number: K022762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2021
• Device Catalogue Number: AGH146000
• Device Lot Number: 180509A25A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/07/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 12/07/2018
• Supplement Dates FDA Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 86 YR