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

Catalog Number	AHW14R004S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Single reporter exemption #e2015028.The returned guide wire was missing its ball tip.Distal to the proximal-mid solder set at 70mm from the tip, coils were found stretched at several points.Microscopic observation revealed that the coil wire was wrenched off as coils got tightened at approximately 13mm distal to the distal-mid solder set at 20mm from the tip.Proximal to the coil wire fracture, the core was found fractured.The core, composed of the twist wire and the core wire, was exposed for microscopic observation.Both twist wire and core wire were twisted and fractured at the same point, distal to the distal solder of the inner coil wire.These findings indicated that approximately 7mm of the tip segment was missing.Coils of the inner coil wire were loosened by torsion so that the coil pitch became wider.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 quality deficiency.Based on the obtained information and investigation outcome, it was concluded that torsion exceeding the product's design limit was generated by wire manipulation possibly when the wire tip was being trapped in the severely calcified vessel.That excess stress was assumed to have contributed to the reported wire fracture.Stretching of the coil wire was assumed to be occurred by tensile stress generated along with wire removal.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; [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] separation of the guide wire.
Event or Problem Description
It was reported that the procedure was to treat a severely calcified cto of the rca.An asahi guide wire was navigated through the lad septal collaterals.The calcified, tortuous vessels caused the guide wire to shear.A perforation occurred, draining into the right sinus; however, it did seal itself before the end of the case.Crossing the cto was not accomplished, the case ended with no patient discomfort or complications.The patient was stable.
Additional Manufacturer Narrative
Asahi intecc has determined that the date recorded "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
• Common Device Name: 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: 8288032
• Report Number: 3003775027-2019-00014
• Device Sequence Number: 1953346
• Product Code: DQX
• UDI-Device Identifier: 04547327086226
• UDI-Public: (01)04547327086226(17)210531(10)180525A05A
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K122468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2019
• Report Date (Section F): 01/09/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: AHW14R004S
• Device Lot Number: 180525A05A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2019
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 65 YR