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

Model Number	RF*GA18153A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6: implanted date: device was not implanted d7: explanted date: device was not explanted the actual device was not returned to the manufacturing facility for evaluation.Reproductive testing was performed on a current guidewire sample.The product sample was inserted into a metal needle and withdrawn from it in the manner of the guidewire sample having contact with the metal needle.The urethane outer layer was s semi-circumferentially sheared off from the guidewire sample.The surface of the shear cross-section of the urethane outer layer was found to be in the smooth state.A review of the device history record and shipping inspection record of the involved product code/lot# combination was conducted with no findings.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely that the actual sample was subjected to a withdrawal manipulation in the state where its urethane outer layer had contact with a hard object, including a metal needle, used in combination with the actual sample.As the result, the urethane outer layer got sheared off the actual sample.However, with no return of the actual sample, 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.
Event or Problem Description
The user facility reported that during the radiology insertion of ccip line, it was discovered that the outer mantle of the glidewire was removed from the guide in the patient's arm.Additional information was received on january 28, 2019.The procedure was a picc line.The mantle is the black cover part.The mantle of the guidewire was stuck in the patients arm.The outer mantle of the guidewire was able to be pulled out.The patient was reported to be doing well.The procedure was stopped.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1.It was initially deemed that the event was other serious.However, it has been deemed as; required intervention to prevent permanent impairment/damage (devices), not other serious; therefore this section has been corrected.

• Brand Name: RADIFOCUS GUIDEWIRE M
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city
• MDR Report Key: 8290365
• Report Number: 9681834-2019-00006
• Device Sequence Number: 11298076
• Product Code: DQX
• UDI-Device Identifier: 04987350772855
• UDI-Public: 04987350772855
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K863138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2019

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: 03/31/2020
• Device Model Number: RF*GA18153A
• Device Catalogue Number: GR1805
• Device Lot Number: 180412
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 02/01/2019
• 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