MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. ASAHI REGALIA XS 1.0; PERIPHERAL GUIDE WIRE

Catalog Number PAGP140000

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturing site: asahi intecc hanoi co., ltd.(b)(4), registration number: (b)(4).The guide wire and its fragment were returned for evaluation.The returned guide wire had its coil wire elongated for approximately 150mm originating from the proximal solder set at 120mm from the wire tip.Torn fragments of the polymer jacket were remaining on the elongated coil wire.At approximately 95mm distal to the proximal solder, the core wire was found fractured.The wire fragment was approximately 100mm long and deformed into a hook on the distal segment.Microscopic observation was performed.The fracture end of the core wire was necked that indicated tensile stress had contributed to the core wire fracture.The fracture surface of the coil wire was flat due to torsional stress generated as coil structure got straightened.A ball tip was found attached on the distal end of the wire fragment.Distal to the fracture end, coils and the polymer jacket were found stretched.The surface of the polymer jacket was scratched possibly by contacting relatively hard object.To observe the fracture end on the distal side, the polymer jacket was removed.Coils were found stretched for approximately 3mm.The coil wire on the distal side also had a flat fracture surface as seen on the proximal side.Coils were removed to observe the distal fracture end of the core wire.The core wire was found fractured proximal to the middle solder set at 25mm from the wire tip.Necking of the fracture end was confirmed as seen on the proximal side of the core wire fracture.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received for 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 concomitant stent delivery system.That stress led the distal wire to be pulled and eventually torn off.There was no indication of product deficiency.Although there were reportedly no adverse patient effects, damage of the guide wire was too severe to completely rule out a possibility that some fragment(s) might be left in the patient anatomy.The instructions for use (ifu) states: warnings- if resistance is felt between this guide wire and the other interventional devices while operating this guide wire in the blood vessel, avoid applying excessive force.When abnormal resistance is felt, remove the entire system from the patient's body and determine the cause.Otherwise, the guide wire may break or be damaged and may cause injury to the blood vessel or leave fragments inside the vessel; and, malfunction and adverse effects- separation or breakage of the guide wire.

Event Description

It was reported that an asahi guide wire became separated during a ppi to treat a cto in the right eia and 99% stenosis in the right sfa-pop.A 0.035 inch guide wire was advanced towards the eia lesion with difficulty in delivering a stent.The asahi 0.014 inch guide wire was replaced with another non-asahi 0.014 inch buddy wire in order to deliver the stent.During removal of the asahi guide wire, strong resistance was felt and wire fracture occurred.The guide wire and the stent delivery system were removed together in order to retrieve the wire fragment.The procedure was resumed and successfully completed with reestablished blood flow of both eia and sfa-pop.There were no adverse patient effects or sequelae secondary to wire fracture.

Manufacturer Narrative

Asahi intecc has determined that the "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 REGALIA XS 1.0
• Type of Device: PERIPHERAL GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 8182759
• MDR Text Key: 130999053
• Report Number: 3003775027-2018-00221
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04547327058186
• UDI-Public: (01)04547327058186(17)210731(30)1(10)180821A07A
• Combination Product (y/n): N
• PMA/PMN Number: K083146
• 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

• Date FDA Received: 12/19/2018
• 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: PAGP140000
• Device Lot Number: 180821A07A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Date Manufacturer Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 48