MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M; WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.Review of the manufacturing record and the shipping inspection record of the involved product code/lot# combination confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot# combination from other facilities.The actual device has not been received yet for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.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 wire broke off in the patient.The device was implanted in the patient and then removed.A snare was used to get broken wire out.The broken wire was removed and another gs3509 was used.The estimated blood loss was less than 250cc.The patient was fine.There were no other devices or equipment used with the reported product.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to update section d9, update section h3, and to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Based on our past knowledge, we have been aware that the guidewire was fractured when the following force was applied.We have also been aware that there was regularity in the shape of fractured section of the core depending on the mechanism leading to the fracture.When continuous torque force was applied in the same direction while the guidewire was bent, and the guidewire was fractured.No taper was found on the side surface of core at the fractured section, and it was flat.Radial patterns were found on the fracture surface of core.When continuous torque force was applied in the same direction while the guidewire was straight, and the guidewire was fractured.A spiral pattern starting from the center was found on the fracture surface of core.When repeated 90° bending force was applied, and the guidewire was fractured.No taper was found on the side surface of core at the fractured section and it was flat.Dimple patterns (hole-shaped patterns) were found on the fracture surface of core.When pulling force was applied, and the guidewire was fractured.Taper was found on the side surface of core at the fractured section.When pulling force was applied to a guidewire in a looped state, and the guidewire was fractured.Taper and curve were found on the side surface of core at the fractured section.According to the investigation results, no anomaly was found in the manufacturing record and the shipping inspection record.It was inferred that the actual sample was fractured due to having experienced one of the situations.However, since the actual sample was not returned and investigation could not be performed, it was not possible to identify the cause of occurrence.Ashitaka factory assures the quality of this product by performing following inspections and control.Through eddy current flaw detection*, it is confirmed that there is no crack in the core over the entire length.The outer diameter of core is controlled to assure the strength of core.Before the packaging process, 100% visual inspection is performed to confirm that there is no anomaly such as a kink or scratch.(eddy current flaw detection: when an alternating current is passed through a coil, a magnetic field is generated in the direction perpendicular to the current.When the coil is brought close to the conductor (core), an eddy current is generated on the surface of the conductor.If any anomaly including a crack is generated in the conductor, the eddy current avoids the crack and flows around the conductor, so that the flow changes as compared with the case where there is no crack.The method of detecting changes in the flow of eddy currents and searching for cracks is called eddy current flaw detection).The 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 and/or the catheter and determine the cause by fluoroscopy.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.".
Additional Manufacturer Narrative
A4: patient weight: 60.5kg.
Event or Problem Description
Additional information was received on 16nov2023: the procedure performed was femoral tibial bypass.The patient was stable.

• Brand Name: RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M
• 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 ; 6402040886
• MDR Report Key: 16821080
• Report Number: 9681834-2023-00092
• Device Sequence Number: 6709069
• Product Code: DQX
• UDI-Device Identifier: 04987350773210
• UDI-Public: 04987350773210
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2023

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: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: GS3509
• Device Lot Number: 210921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 05/23/2023; 11/16/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 06/19/2023; 12/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White