MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M; 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	04/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted, explanted date: device was not explanted, occupation: interventional radiology (ir) tech.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.A 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 report with the involved product code/lot number combination from other facilities.(b)(4).
Event or Problem Description
The user facility reported that the outside coating stripped off the wire involved.The patient was not injured.There was no patient injury/medical or surgical intervention required.Additional information was received on 28 apr 2022: the procedure performed was a leg angiogram.The coating stripped off the wire after the crossover sheath exchange.The patient was in stable condition.The coating was not left in the patient's body.There was no blood loss.The procedure outcome was successful.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.Visual inspection of the actual sample obtained that the peeling of outer layer and exposure of the core wire was observed at approx.835 mm from the distal end.Some of the flaws were observed near the area where the outer layer had peeled, extending approximately 35 mm.Magnifying inspection of the area where the outer layer had peeled obtained the following results: i) elongation of outer layer was observed; ii) the outer layer was in a torn-off shape; iii) flaws were observed on the surface of exposed core wire; iv) spiral flaws were observed on the outer layer near the area where the outer layer had peeled.Magnifying inspection of the reverse side of this area found that the outer layer was in a torn-off shape.Electron microscopic inspection found that the outer layer surface around the area where the outer layer had peeled was rough, and a rough surface was observed on the reverse side.Magnifying inspection of the other area found no flaw or other anomalies.Based on the condition of the actual sample, it was inferred that the torque force and push-pull force was applied while some object was in contact with the area in question.The effective length was measured and confirmed to meet the control standards.The outer diameter was measured at the normal section and confirmed to meet the control standards.A simulation test obtained the following results: based on the condition of the actual sample, it was inferred that the torque force and push-pull force was applied to the actual sample while some object was in contact with the area in question.Therefore, a simulation test was implemented by applying torque force and push-pull force to a guidewire sample while a concurrently used device (torque device) was not sufficiently fixed to the guidewire.Metal torque device and resin torque device were used in this simulation test.Metal torque device: visual inspection of the guidewire sample obtained the following results: i) peeling of outer layer and exposure of the core wire was; ii) some flaws were observed near the area where the outer layer had peeled.Magnifying inspection of the area where the outer layer had peeled obtained the following results: i) elongation of outer layer was observed; ii) the outer layer was in a torn-off shape; iii) flaws were observed on the surface of exposed core wire; iv) spiral flaws were observed on the outer layer near the area where the outer layer had peeled.Electron microscopic inspection found that the outer layer surface around the area where the outer layer had peeled was rough and some flaws were observed.Based on the above results, it was considered that the condition of the guidewire sample tested in combination with the metal torque device was similar to that of the actual sample.However, the peeling of the outer layer and the roughness of the surface near the area where the outer layer had peeled were larger in degree than the actual sample.These differences were considered to depend on the degree of adhesion between the outer layer of guidewire and the torque device, and on the ways of manipulation.Resin torque device: visual inspection of the guidewire sample found some flaws on the outer layer surface.Magnifying inspection of the guidewire sample found that the outer layer surface was rough.Electron microscopic inspection of the guidewire sample found some spiral flaws on the outer layer surface.Based on the above, the condition of the guidewire tested in combination with the resin torque device was different from that of the actual sample; therefore, the peeling of outer layer of the actual sample was not caused by this mechanism.From the investigation results, it was inferred that the peeling of outer layer and the exposure of core wire had occurred due to the application of torque force and push-pull force to the actual sample while some object was in contact with it.From the simulation test results, it was inferred that this might have occurred when torque force and push-pull force was applied to the actual sample while a metal torque device was not sufficiently fixed to it.In the manufacturing process, the quality of the products is assured through the thorough work and inspections, including 100% visual inspection to confirm that there is no exposure of core wire or other external anomalies.Nevertheless, in light of this complaint, we will once again ensure thoroughness in our operations and inspections.The following cautions/warnings are indicated in the instructions for use (ifu) of this product: "use the enclosed radifocus torque device to handle the guide wire m.Do not use a metal torque device with the guide wire m.Use of a metal torque device may result in damage to the wire." "do not slip a tightened up torque device or y-connector over the wire, as this may result in damage to the wire.".

• Brand Name: RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M
• 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: 14461078
• Report Number: 9681834-2022-00093
• Device Sequence Number: 19992867
• Product Code: DQX
• UDI-Device Identifier: 04987350773654
• UDI-Public: 04987350773654
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 05/20/2022

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: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: GS3509
• Device Lot Number: 210902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2021
• 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 Age: 83 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White