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

Model Number	RF*PA35183A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was not returned to the manufacturing facility for evaluation.However, a current guidewire sample was inserted into a metal needle and withdrawn from it in the manner of the guidewire sample having contact with the metal needle.The urethane outer layer was sheared off from the guidewire sample.Magnifying inspection of the sheared section of the urethane outer layer found that its surface was in the smooth state as if it had been cut with a cutting tool with the presence of a semi-circumferential groove noted.A review of the device history record of the product code/lot# combination was conducted with no findings.Based on the investigation, it is likely that the actual sample may have been withdrawn through a metal device, including a metal needle, in the manner of it having contact with the metal device, resulting in shearing of the urethane outer layer.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.Ifu states: do not use the glidewire with devices which contain metal parts such as atherectomy catheters, laser catheter, or metal introduction devices as they may cause the glidewire plastic coating to shear and/or sever the wire.Do not manipulate or withdraw the glidewire 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.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.Exemption number e2015022.- attachment: [mw5086001.Pdf].
Event or Problem Description
Terumo medical received an fda medwatch report # mw5086001.The event description states: "during insertion of hemodialysis catheter into the right internal jugular vein, a piece of the hydrophilic coating frayed off the guide wire.The piece became attached to the wall of the internal jugular vein.Multiple attempts to remove the piece was attempted using multiple snare wires.All attempts failed".
Additional Manufacturer Narrative
It was inadvertently submitted as "other serious"; however, the correct selection is "required intervention to prevent permeant impairment/damage".Therefore, the correct selection has been made.

• Brand Name: RADIFOCUS GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 8636301
• Report Number: 9681834-2019-00078
• Device Sequence Number: 2268500
• Product Code: DQX
• UDI-Device Identifier: 04987350773630
• UDI-Public: 04987350773630
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K863138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

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: 10/31/2021
• Device Model Number: RF*PA35183A
• Device Catalogue Number: GS3508
• Device Lot Number: 190211
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 05/24/2019
• 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: Other; Required Intervention