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

Model Number	RF*PA35183A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6: implanted date: device was not implanted d7: explanted date: device was not explanted h6: patient code 3191 - sheared coating retrieved during procedure.The involved device was not returned for evaluation.Therefore, the investigation was based on user facility information and evaluation of a current guidewire product.Based on the investigation, it is likely that the actual device was subjected to a withdrawal manipulation in the state where its urethane outher layer had contact with a hard object.As a result, the urethane outer layer got sheared off the actual device.However from the available information with no return of the acutal device for evaluation, the exact cause of the reported event cannot be definitively determined based on the available information.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: [mw5082281.Pdf].
Event or Problem Description
This report is being submitted in response to fda mw5082281.The user facility reported that the coating over the guidewire appeared to be sheared off during the procedure.This was retrieved during an interventional radiology (ir) intervention.On the package there is a cautionary statement: "do not use with metal entry needle." request of manufacturer to highlight and enlarge the cautionary statement on the package.
Event or Problem Description
Additional information was received on january 29, 2019.The procedure being performed was a porta cath insertion.The issue was resolved with the retrieval of the coating.No surgical intervention required.The patient was reported to be in stable condition with no further complications.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.

• Brand Name: RADIFOCUS GLIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 8289601
• Report Number: 9681834-2019-00005
• Device Sequence Number: 2540743
• Product Code: DQX
• UDI-Device Identifier: 04987350773630
• UDI-Public: 04987350773630
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K863138
• 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): 01/30/2019

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 Model Number: RF*PA35183A
• Device Catalogue Number: GS3508
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 02/05/2019
• 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: Required Intervention
• Patient Age: 48 YR