MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M; WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- lead tech.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record and the shipping inspection record of the involved product code/lot# combinations were conducted with no findings.Based on past findings, it is recognized that the guidewire may be fractured when exposed to the loads described below.It is recognized also that there is a regularity in the shape of the fracture of the core wire depending on the mechanism leading to the fracture.Fracture due to a repeated bending load at 90-deg shows that the fracture end of the cores wire is not tapered, and dimple pattern is observed on the fracture surface.Fracture due to a one-way torque load to the product kept in a bent shape shows that the fracture end of core wire is not tapered, and radial pattern is observed on the fracture surface.Fracture due to a pulling load in one-direction shows that the outside diameter of the core wire has been diminished toward the fracture end.Fracture due to pulling load to the product kept in a loop shape shows that the fracture end of the core wire has been curved and tapered.Ifu states: if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the glidewire and/or the catheter and determine the cause by fluoroscopy.Failure to exercise proper caution may result in bending, kinking, separation of the guide wire's tip, damage to the catheter, or damage to the vessel.It is likely that actual sample might have been fractured due to having been exposed to one of the loads described in the investigation results.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.Please see mdr (b)(4) for the importer report.(b)(4).
Event or Problem Description
The user facility reported that something was noticed on the tech screen.The tip of the radifocus wire broke off in the patient.They checked the wire off the table; tip was split and the part that split broke off.There was no patient injury, medical/surgical intervention required.The patient's condition was stable.Additional information was received on 02aug2021.The procedure being performed was a left leg angiogram.The wire was located in the patients left lower leg/ sfa.The tip of the wire was not retrieved from the patient's body.There was no blood loss.Once the tip broke the procedure was perused with intentions to fix the distal occlusion, no success in getting pack the blockage; not due to the wire; due to the occlusion.

• Brand Name: RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 12306648
• Report Number: 9681834-2021-00147
• Device Sequence Number: 11958478
• Product Code: DQX
• UDI-Device Identifier: 04987350773654
• UDI-Public: 04987350773654
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K863138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2021

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: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: GS3509
• Device Lot Number: 210218
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GOLD WIRE
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 82