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

Model Number	GM1811
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the tip of the wire or marker band broke off in the lesion in the peroneal artery during a peripheral vascular disease (pvd) intervention.The patient was in good condition; however, they were not able to complete the intervention due to extensive disease.Additional information was received on 22-oct-2021.The broken tip or marker band remains in the patient.The marker band/tip is in the peroneal artery, lodged where it is occluded with calcium.Fluoro was done to confirm the location.
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.For this reason, investigation conclusions code has been referenced.A review of the manufacturing record and the shipping inspection record of the involved product code/ lot # combination was conducted with no findings.Please see mdr 2243441-2021-00058 for the importer report.(b)(4).
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update sections d9 and h3, and to provide the completed investigation results.Ashitaka factory was informed on january 20, 2022 that the actual sample was not available for analysis.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, the broken ends of the core wire present some regularity depending on the mechanism of the breakage.Repeated 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 ends become tapered and curved.Based on the investigation result, it is conceivable that the actual sample was broken off due to one of the mechanisms described in the investigation result 2.However, the cause of occurrence could not be clarified since the actual sample was not available for analysis.Ifu states: "if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the guide wire m 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." terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: RADIFOCUS GLIDEWIRE
• 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: 12808691
• Report Number: 9681834-2021-00205
• Device Sequence Number: 5575603
• Product Code: DQX
• UDI-Device Identifier: 04987350774194
• UDI-Public: 04987350774194
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 11/14/2021

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: GM1811
• Device Catalogue Number: GM1811
• Device Lot Number: 210201
• 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: 10/20/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 11/14/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• 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: Other
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: White