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 Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturing site: asahi intecc.(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 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.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 target lesion might be inadvertently applied while the distal segment of the guide wire was being trapped in the lesion.When the applied stress exceeded the product's design limit, it likely led the wire to become separated.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 during a procedure to treat the mid lcx an asahi guide wire tip separated and was snared out of the superficial femoral artery.The final patient outcome was good and no adverse patient effects were reported.There was no 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: 8188526
• MDR Text Key: 131138153
• Report Number: 3003775027-2018-00224
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04547327056120
• UDI-Public: (01)04547327056120(17)210331(10)180418A20A
• 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: 12/06/2018

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: 03/31/2021
• Device Catalogue Number: AGH146000
• Device Lot Number: 180418A20A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/06/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 12/06/2018
• Supplement Dates FDA Received: 12/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention