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

Model Number	N/A
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that there was no polytetrafluoroethylene (ptfe) coating on the guidewire involved.The patient was ok.The outcome of the procedure was positive.There was no patient injury/medical or surgical intervention required.Additional information was received on 01 feb 2022: the procedure was completed using a cook roadrunner wire.
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: leah tech.A review of the device history record of the product code/lot# combination was conducted with no findings.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.(b)(4).
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to update section h3, and to provide the completed investigation results.Based upon the investigation of the unopened samples this event has been reassessed and has now been deemed not a reportable event.The inspection of the two unopened returned samples upon receipt found no abnormalities in the appearance, dimensions, or manufacturing related records of the actual sample.The cause of the problem reported could not be clarified snice the samples were verified to be of normal products; therefore, is not a reportable event.Ashitaka factory is always continuing diligence in maintaining the product quality by performing thorough work and inspections, for example, as follows: (i) the outer diameter of the product is controlled; (ii) the homogeneity of the hydrophilic coating solution is guaranteed by controlling the balance of materials and the stirring time; (iii) the uniformity of the hydrophilic coating layer is guaranteed by controlling the application conditions (coating speed and immersion time); (iv) after the application of hydrophilic coating, sliding performance is checked to ensure that the hydrophilic coating has been applied properly.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9 and to update section h3.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.

• 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
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: stephanie handy ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 13548370
• Report Number: 9681834-2022-00021
• Device Sequence Number: 5236129
• Product Code: DQX
• UDI-Device Identifier: 04987350773159
• UDI-Public: 04987350773159
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2022

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: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: GR3506
• Device Lot Number: 210604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 02/24/2022; 03/22/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 03/23/2022; 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown