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

Model Number	RF*GA38153A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	07/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 product-release judgement record of the involved product code/lot# combination was conducted with no findings.(b)(4).Please see mdr (b)(4) for the importer report.
Event or Problem Description
The user facility reported that the doctor inserted the glidewire through his access needle and it sheared off about 30-40cm of the jacket of the wire.The doctor had to access the opposite femoral artery to retrieve the detached sleeve with a snare.The patient's condition was stable.There was no patient injury, medical/surgical intervention required.Additional information was received on 23jul2020.An angio procedure was being performed.They are not aware that any of the glidewire was left in the patient.Fluoroscopy was used to snare the jacket.There was no harm to the patient.Once jacket portion was snared, they finished getting their imaging.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.The actual samples (a guidewire and a fragment) were received for evaluation.The guidewire and the fragment are referenced as sample a and sample b.Visual inspection of sample a revealed that the urethane outer layer had been severed.It was observed approximately 18 mm - 122 mm from the distal end (approximately 104mm in length).Magnifying inspection of the urethane-severed area found that the severed surface was smooth.The core wire was exposed from approximately 32 mm from the distal end (approximately 14 mm from the distal end of the urethane-severed area) to the proximal end of the urethane-severed area.Electron microscopic inspection of the urethane-severed area revealed that the distal end had been severed straight whereas the proximal end of that area had been severed in a curve shape.Visual inspection of sample b revealed that the length of sample b was 104 mm.Both ends were called end-1 and end-2.Magnifying inspection found that the severed surface was smooth.A groove was found located in the severed surface on approximately 14mm from end-1.Electron microscopic inspection revealed that end-1 had been severed straight whereas end-2 had been severed in a curve shape.Combination check: the shape of severed surface of sample a and sample b were checked.It was confirmed that the distal end of the urethane-severed area of sample a was fit with end-1 of sample b, and the proximal end of the urethane-severed area of sample a was fit with end-2.From this, it was most likely that there was no deficient part in the urethane outer layer of the actual sample.Dimensional check: the outer diameter of sample a was measured on the undamaged area and confirmed to meet the control criteria.Prior reproductive testing based on experiences has revealed that the urethane outer layer may be severed, and the core wire may be exposed when the guidewire is used in combination with a metal needle and withdrawn from a metal needle.In such a case, the severed surface becomes smooth.Ifu states: do not manipulate or withdraw the glidewire advantage through a metal entry needle or a metal dilator.Manipulation and/or withdrawal through a metal entry needle or a metal dilator may result in destruction and/or separation of the outer polyurethane coating requiring retrieval.A plastic entry needle is recommended when using this wire for initial placement.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 guidewire was used in combination with the metal needle and came into contact with the needle point when pulled, resulting in the severed urethane outer layer.It was conceivable that there was no deficient part in the urethane outer layer since the shape of the severed surfaces of sample a and b were fit to each other.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• 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: 10355829
• Report Number: 9681834-2020-00157
• Device Sequence Number: 14243657
• Product Code: DQX
• UDI-Device Identifier: 04987350773357
• UDI-Public: 04987350773357
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2020

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: 02/28/2021
• Device Model Number: RF*GA38153A
• Device Catalogue Number: GR3806
• Device Lot Number: 190314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 09/16/2020
• 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: Required Intervention