MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS INTRODUCER; INTRODUCER, CATHETER

Catalog Number RM*RF6J10PQ

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/02/2020

Event Type  Injury  

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.510(k): k062858, k082644.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and the shipping inspection record of the product code/lot# combination was conducted with no findings.(b)(4).

Event Description

The user facility reported that the radifocus introducer was used during the procedure.During the removal of the guide there was a sudden rupture with detachment of the spiral-like covering with entrapment in the radial artery.They attempted to clamp the introducer to incarcerate the guide.The introducer was removed; however, without removing the guide filament fragment.A part of the 5 cm spiral-shaped component remained inside the patient's radial artery.Evaluation of the vascular surgeon who indicated no removal.No removal procedure has been carried out.The procedure outcome was not reported.There was no harm to the patient.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in section d10, update section h3, and to provide the completed investigation results.The actual sample was received for evaluation.Visual inspection of the actual spring mini guidewire sample revealed that the coil had been unraveled with resultant exposure of the core wire.Magnifying inspection found that the exposed core wire had been curved, and there were two points slightly kinked in that curved area.Electron microscopic inspection revealed: fracture section of the coil was smooth and not having been elongated, fracture section of the core wire was deformed in a tapered shape due to having been elongated.Reproductive testing was performed with a factory-retained spring mini guidewire (guidewire) and a metal needle (needle).A kink was given to the guidewire at approximately 50mm from the distal end, the needle was punctured in pvc tube, and then the guidewire was inserted in the needle, the guidewire was pulled out of the needle at a near-perpendicular angle to the pvc tube.As a result, the distal end of the guidewire was caught by the distal opening of the needle, the coil of the guidewire was unraveled with resultant exposure of the core wire, the exposed core wire was curved, and slight kinks occurred at two points in that curved area.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that the actual spring mini guidewire sample was manipulated at an angle near perpendicular to the vessel and became bent.Subsequently, when being withdrawn, it became caught at the distal opening of the metal needle, resulting in the shearing.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: RADIFOCUS INTRODUCER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 10100366
• MDR Text Key: 195107082
• Report Number: 9681834-2020-00090
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K033681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: RM*RF6J10PQ
• Device Lot Number: 191031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Date Manufacturer Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR