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

Catalog Number AH14R104S

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The guide wire was returned for evaluation.The returned guide wire had its coil wire elongated from the proximal-mid solder set at 70mm from the tip.Under the elongated coil wire, the inner coil wire was exposed.The inner coil wire was found stretched.The core, composed of a straight wire and a twist wire, was found fractured distal to the inner coil wire.Microscopic observation of the fracture ends revealed that each fracture end was necked; the finding indicated that core fracture was due to tensile stress.The coil wire remained in one piece as a ball tip remained attached on the very distal end of the elongated coil wire.Coils were removed to observe the distal side of the core fracture.The core was found fractured at approximately 8mm proximal to the tip.Both straight wire and twist wire showed necking of the fracture ends due to excess tensile stress.Measurement of the core length suggested the entire guide wire was 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 and investigation outcome, it was concluded that tensile stress exceeding the product's design limit was inadvertently applied while the wire tip was being trapped by the severely calcified cto.There was no indication of product deficiency.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] breakage of the guide wire.

Event Description

It was reported that and asahi guide wire became trapped during a pci to treat a heavily calcified cto in the lad #8.The guide wire was used in attempts to cross the lesion when its tip was caught by the lesion.During wire removal from the patient anatomy, the core was found fractured with coil elongation.A new guide wire was replaced to cross the lesion.The procedure was successfully completed with reestablished blood flow with stenting.The physician commented that he advanced the guide wire too far.The patient was fine without problem after the procedure.

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 SION BLUE
• 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: 8182760
• MDR Text Key: 131800675
• Report Number: 3003775027-2018-00222
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04547327095907
• UDI-Public: (01)04547327095907(17)210630(30)1(10)180723A68A
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: AH14R104S
• Device Lot Number: 180723A68A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Date Manufacturer Received: 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1