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

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: inventory control coordinator.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Review of the manufacturing record and the product release judgement record of the involved product/lot number combination confirmed there was no problem in them.A search of the complaint file found no other similar reports with the involved product code/lot number combination from other facilities.According to the investigation results, no anomaly was found in the relevant records.From the description of the complaint, it was inferred that the actual sample might have come into strong contact with the concurrently used device.However, since the actual sample was not available for analysis, the cause of occurrence could not be clarified.Ashitaka factory assures the quality of this product by implementing the following inspections and control.The core wire is checked for its integrity over the entire length through the eddy current flaw detection.The outside diameter of the core wire is strictly controlled to assure the strength of the core wire.100% visual inspection is performed before the packing process to assure there is no anomaly in the appearance such as a kink.The following warning is indicated on the ifu: the glidewire is designed to direct a catheter to the desired anatomical location during diagnostic or interventional procedures.(b)(4).
Event or Problem Description
The user facility reported that the guidewire involved was used in the attempt to retrieve an inferior vena cava (ivc) filter.The wire flawed when it was being removed from the catheter.The patient had no issues.The outcome of the procedure was completed.There was no patient injury/medical or surgical intervention required.Additional information was received on 24 feb 2022: the patient was in stable condition.There were no complications with the procedure being completed.

• 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: 13695526
• Report Number: 9681834-2022-00031
• Device Sequence Number: 19228659
• Product Code: DQX
• UDI-Device Identifier: 04987350773197
• UDI-Public: 04987350773197
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2022

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: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: GR3508
• Device Lot Number: 210512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2022
• Initial Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2021
• 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