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

Model Number	N/A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Review of the manufacturing record and the shipping inspection record found no anomaly.No other similar report from other facilities was found.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Event or Problem Description
The user facility reported that the coating of the advantage wire was stripped off in one area.They did use wire on the patient and then it was noticed.There was no known harm to the patient; however, it was unknown what happened to that portion of wire coating.No blood loss was reported.There was no patient injury/medial or surgical intervention required.There is not a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.The event occurred intra-operative.Additional information was received on 06 feb 2024: the procedure was an exchange of a nephrostomy tube to a nephroureteral placement.The size was three different spots.The first was a very short segment less than a millimeter (mm).The second was approximately 6mm and the third was 3-4mm.There was some difficulty when exchanging one catheter to the next, where it was not a smooth transition over the wire.No testing was done, and pieces were not found.No intervention was needed.The patient had no complications, patient was good.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, add a report number to section h10, and to provide the completed investigation results.Only a glidewire advantage main body was received.Magnifying inspection showed that the outer layer had been notched at approximately 250mm from the distal end.The ptfe coating had been peeled off at multiple sections (at approximately 280mm - 320mm from the distal end [between approximately 40mm], at approximately 461mm from the distal end, at approximately 534mm - 622mm from the distal end [between approximately.88mm], and at the rear end).Optionally, only the section at approximately 534mm - 622mm from the distal end was confirmed.Only half of the circumference had been peeled off.Confirmation of dimensions: outer diameters of the hydrophilic coating section and the ptfe coating section met the factory's specifications.No anomaly was found.No anomaly was found in the manufacturing record and the shipping inspection record.No other similar report was found in the past.Simulation test: test method: the removal operation was performed with glidewire advantage curved and in strong contact with the metal device.Test result: the ptfe coating was peeled off.Based on the investigation result, as a possible cause of this case, it was likely that glidewire advantage was curved and removed while in strong contact with some hard object (e.G., metal).However, since the details of procedure were unknown, it was not possible to clarify exactly what the hard object was.Ashitaka factory has been making efforts in maintaining the quality of the product by performing following controls.In the product assembling process, 100% visual inspection is performed to confirm that there is no anomaly in the appearance.Instructions for use (ifu) of this product includes the following warning: "if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the glidewire advantage and/or the catheter and determine the cause by fluoroscopy.Continuing to manipulate or rotate the glidewire advantage or failure to exercise proper caution may result in bending, kinking, separation of the guide wire's tip, damage to the catheter, or damage to the vessel.".

• Brand Name: RADIFOCUS GLIDEWIRE ADVANTAGE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 4103927218
• MDR Report Key: 18659475
• Report Number: 9681834-2024-00015
• Device Sequence Number: 17924517
• Product Code: DQX
• UDI-Device Identifier: 04987350703620
• UDI-Public: 04987350703620
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K063372
• 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
• Report Date (Section B): 02/07/2024

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: 06/30/2025
• Device Model Number: N/A
• Device Catalogue Number: GA3501
• Device Lot Number: 230710
• 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: 01/22/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2023
• 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