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	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the tip of wire broke off inside the patient.The tip was snared, and the patient was not injured.The patient was stable, and the procedure was successful.Additional information was received on 16-sept-2021.Fluoro was used to confirm that there were no remaining particles left in the patient.The procedure performed was an aortoiliac procedure.The patient has eccentric plaque & heavily calcified occlusion.
Additional Manufacturer Narrative
Patient height - 170.2cm, implanted date: device was not implanted, explanted date: device was not explanted.Occupation- rt.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.For this reason, investigation conclusions code has been referenced.A review of the device history record and the shipping inspection record of the involved product code/ lot # combinations were conducted with no findings.Please see mdr 2243441-2021-00048 for the importer report.(b)(4).
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, and to provide the completed investigation results.The analysis of the actual sample was returned for evaluation.Visual inspection of the actual sample upon receipt obtained the following results.It had been fractured at approx.45mm from the distal end and was divided into a fractured piece and a main body.The total length of fractured piece was approx.45mm.The total length of main body was approx.1755mm.From investigation result 1, it was confirmed that the total length of actual sample was approx.1800mm (fractured piece [approx.45mm] + main body [approx.1755mm]).Since the total length of normal product was approx.1800mm, it was inferred that there is no missing part in the actual sample.The following investigation was performed for each of the fractured piece and the main body.Evaluation of the fractured piece was performed.Visual inspection obtained following results.It had been kinked at approx.30mm and 42mm from the distal end.The wire had been exposed.X-ray fluoroscopic inspection obtained following results.The wire had been kinked inside the section at approx.30mm from the distal end.The wire had been fractured at approx.42mm from the distal end and had been connected by the outer layer.Magnifying inspection found that the outer layer had been elongated in any part from approx.42mm to approx.45mm from the distal end.Electron microscopic inspection obtained following results.The outer layer had been wrinkled in any part from approx.30mm to approx.45mm from the distal end.The fractured wire had been exposed at approx.42mm from the distal end.A torn shape was observed in the outer layer at approx.45mm from the distal end.Evaluation of the main body was performed.Visual inspection did not find any exposure of the wire.Magnifying inspection obtained following results.The outer layer of fractured section had been elongated.No anomaly was found in other sections.Electron microscopic inspection obtained following results.The outer layer of fractured section had been wrinkled.No anomaly was found in other sections.Evaluation of both the fractured piece and main body was performed.The outer layer of actual sample was removed, and electron microscopic inspection of the wire was performed.There was no tapering on the side surface of fractured wire, which was approx.42mm and 45mm from the distal end, and a radial pattern was observed on the fractured surface.The outer diameter was measured and confirmed to meet the specifications.The record inspection results are described in the preliminary report.Simulation testing was performed.We recognize that applying the following force to the guidewire m leads to fracture.There is regularity in the shape of the fractured section of wire depending on the mechanism leading to the fracture.It was fractured by applying continuous torque force in the same direction in a curved state.As a result, a radial pattern was observed on the fractured surface.Since a radial pattern was observed on the fractured surface, it was inferred to be similar to the mechanism of occurrence of the actual sample.It was fractured by applying continuous bending force (90-degree folded bending force).As a result, a dimple pattern (a hole-shaped pattern) was observed on the fractured surface.Since a dimple pattern (a hole-shaped pattern) was observed on the fractured surface, it was inferred to be different from the mechanism of occurrence of the actual sample.It was fractured by applying pulling force in the looped state.As a result, curvature was observed at the fractured section.Since the side surface of fractured section was curved and the fractured surface was rough, it was inferred to be different from the mechanism of occurrence of the actual sample.It was fractured by applying pulling force.As a result, tapering was observed at the fractured section.Since the side surface of fractured section was tapered, it was inferred to be different from the mechanism of occurrence of the actual sample.Ifu states: "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." based on the investigation result, it was likely that since the actual sample was subjected to continuous torque operation in a curved state, the wire was initially fractured at a position of approx.42mm from the distal end due to metal fatigue.In that state, similar force was applied, and the wire was fractured again at a position approx.45mm from the distal end.After that, when the actual sample was operated in the removal direction, the outer layer of the section approx.45mm from the distal end was torn and separated in the patient's body.However, the exact cause of the reported event cannot be definitively determined based on the available information.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

• 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: mary o'neill ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12602640
• Report Number: 9681834-2021-00178
• Device Sequence Number: 4038575
• Product Code: DQX
• UDI-Device Identifier: 04987350773630
• UDI-Public: 04987350773630
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2021

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: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: GS3508
• Device Lot Number: 210223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 10/10/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OMNI FLUSH CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Race: White