MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GLIDEWIRE ADVANTAGE; WIRE, GUIDE, CATHETER

Model Number	RA*CA35265C
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.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 or Problem Description
The user facility reported that the involved radifocus glidewire advantage was used.After initial angio was taken without the wire in the guide, the md inserted the gwa back into the copilot to advanced down the superficial femoral artery (sfa).It was noticed that the wire was not advancing smoothly, and the md pulled the gwa out and noticed the glide coating had been separated.The wire was placed to the side.A versacore wire was used the rest of the case.No harm was noted to the patient; the patient's condition was stable.The procedure was successful.Additional information was received on 14jan2020.The procedure for the patient was an angiography and intervention for sfa.The wire coating separated; however, did not break off.The coating was still attached to the wire.
Additional 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 revealed that the urethane coating had been inverted in the distal direction.Visual inspection with unaided eye and ccd obtained revealed that the distal 183mm was intact; the proximal section of the urethane coating of approximately 30mm in length, which had been peeled off the core wire, had been overlapped on the original urethane coating; the core wire was exposed 34mm in length due to the peeled off urethane coating; the urethane coating of proximal 2mm in length had remained in its original place.Visual inspection of the inverted urethane coating with ccd and sem found some scratches and stretched part on the visible surface.Reproductive testing was performed, a factory-retained guide wire sample of the involved product code was once inserted in a factory-retained catheter, the proximal end of the urethane coating was scratched, and then the guide wire was pulled.As a result, the scratched area got caught at the opening of the catheter, and further pulling force caused the urethane coating to be peeled off the core wire and invert in the distal direction.The state of inversion was confirmed to be similar to that observed on the actual sample.Ifu states:if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the glidewire advantage and/or the catheter and determine the cause by fluoroscopy.Continuing to manipulate or rotate the glidewire advantage or 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.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 a hard object came into contact with the proximal end of the urethane coating causing damage on that area, which made the urethane coating easily turn up.Subsequently, when the actual sample was pulled through the catheter in the proximal direction, the proximal end of the urethane coat got inverted.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: RADIFOCUS GLIDEWIRE ADVANTAGE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9646376
• Report Number: 9681834-2020-00009
• Device Sequence Number: 11484004
• Product Code: DQX
• UDI-Device Identifier: 04987350703644
• UDI-Public: 04987350703644
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K063372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: RA*CA35265C
• Device Catalogue Number: GA3502
• Device Lot Number: 191107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 03/24/2020
• 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: 6FRENCH 55CM LIMA GUIDE.; 6FRENCH PINNACLE, CO.
• Patient Age: 84 YR