MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GLIDEWIRE ADVANTAGE; 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	10/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A maude database search conducted on 14december2021 found a maude report number mw5105119.The event description states: "patient had a cholangiogram with placement of biliary drains.About 6 inches of the glidewire sheared off during the procedure.".
Additional Manufacturer Narrative
Patient identifier - unknown.Age & date of birth - unknown.Patient sex - unknown.Weight -unknown.Ethnicity - unknown.Race - unknown.Lot number: unknown.Expiration date - unknown due to unknown lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Contact - unknown.Address - unknown.Telephone number - unknown.Health professional - unknown.Occupation - unknown.Device manufacturer date - unknown due to unknown lot number.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.It is known from our past experiments that the guidewire may get broken off when it has been subjected to one of the loads described below.In addition, as for the core wire, the state of the broken ends presents some regularity depending on the mechanism of the breakage.Repetitive bending load at a 90-degree angle.The broken ends are not deformed in a tapered shape and dimple pattern is observed on the broken surface.Continuous one-way torque load to a bent wire.The broken ends are not deformed in a tapered shape and radial pattern is observed on the broken surface.One-way pulling load.The broken ends become tapered.Pulling load to a loop-shaped wire.The broken end become tapered and curved.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record and shipping inspection record.Ifu states: "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." since the actual product was not returned, the analysis of it could not be performed.In addition, review of the manufacturing records could not be performed due to unknown lot.It was considered that the breakage of the present product occurred by one of the mechanisms described in the investigation result.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.Please see mdr (b)(4) for the importer report.(b)(4).
Event or Problem Description
Terumo medical received an fda medwatch report # mw5105119.The event description states: "patient had a cholangiogram with placement of biliary drains.About 6 inches of the glidewire sheared off during the procedure.".
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the attached medwatch that was received.

• 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: mary o'neill ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 13195360
• Report Number: 9681834-2021-00257
• Device Sequence Number: 6046725
• Product Code: DQX
• UDI-Device Identifier: 04987350717924
• UDI-Public: 04987350717924
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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 Model Number: N/A
• Device Catalogue Number: GA1430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown