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

Catalog Number AH14R104S

Device Problem Difficult to Remove (1528)

Patient Problem Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

Manufacturing site: asahi intecc hanoi co., ltd.(b)(4).The sion blue guide wire was inserted in the concomitant corsair pro catheter when it was returned.The distal segment of the guide wire approximately 140mm was out of the catheter tip.The catheter tip was found undulated.Under the x-ray, coils of the guide wire in the catheter tip were found unraveled due to accumulated torsion.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received for this lot.Reported stalemate of the sion blue and corsair pro was most likely due to unraveled coils that caused by accumulation of torsion that was possibly applied when the guide wire was being trapped between the deployed stent and the vessel wall.There was no indication of product deficiency.When and how the sion blue contributed to hematoma formation could not be identified; however, possible involvement of the sion blue could not be completely denied.Instructions for use (ifu) states: [warnings] observe movement of this guide wire in the vessels.Before this guide wire is moved or torqued, the tip movement should be examined and monitored under fluoroscopy.Do not move or torque the guide wire without observing corresponding movement of the tip; otherwise, the guide wire may be damaged and/or trauma may occur.In addition, ensure that the distal tip of this guide wire and its location in the vessel are visible during manipulations of the guide wire; [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] removal difficulty of guide wire, vessel dissection.

Event Description

It was reported that the procedure was to treat an in-stent restenosis (75-90% occlusion, stent originally embedded in (b)(6) 2014) in the rca#3 to #4pd.The sion blue guide wire was advanced with a caravel microcatheter in an attempt to cross the lesion but failed.A new guide wire (xt-r) was replaced and reached the peripheral 4pd.A scoring balloon was inflated at the 4pd.The sion blue was delivered to the 4av to perform poba.Kissing balloon technique with scoring balloon and balloon was performed in both 4pd and 4av.After drug coated balloon was inflated in the 4av, balloon dilatation in the proximal #3 was performed with a scoring balloon.Then ivus showed a hematoma-like image at the ostium of #1 through the proximal #3.Xt-r in the 4pd was used to deliver a stent to reestablish the blood flow and to compress the hematoma in the #1 through #3.After stent deployment it was noted that the sion blue was stuck between the stent and the vessel wall.A corsair pro catheter was advanced distal to the stuck sion blue to successfully pull out the guide wire from the anatomy.Final angiograph showed good stent expansion and reestablished blood flow at the end of the procedure.The patient was discharged as previously planned without problem.The physician returned the sion blue to have the manufacturer evaluate whether it had any damage.

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 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: 8182724
• MDR Text Key: 131135766
• Report Number: 3003775027-2018-00218
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04547327095907
• UDI-Public: (01)04547327095907(17)210731(30)1(10)180824A35A
• 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: 11/28/2018

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: 07/31/2021
• Device Catalogue Number: AH14R104S
• Device Lot Number: 180824A35A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 11/28/2018
• Supplement Dates FDA Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 58