MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA R2P MISAGO; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	SXR08040R
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that while loading the stent onto the guidewire, the stent was accidentally released due to the roller ball being depressed upon opening the package.A second misago stent was used successfully in the procedure.There was no injury to the patient and no blood loss.The procedure performed was a leg av fistula.Additional information received on 15 oct 2024: they did not depress the roller ball but were unsure of what occurred between opening the package and starting to use it.This incident did not cause any harm during the procedure or to the patient.The stent never entered the sheath or the patient.
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.History investigation of the involved product code and lot#.No anomaly was found in the manufacturing record and the product inspection record.No similar report was found in the past complaint file.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to correct section d9 and to provide the completed the completed investigation results.The actual device is not available for returned; therefore, an evaluation of the actual device was unable to be conducted.In this particular case, it can be deduced that the thumbwheel was unlocked due to some factor, e.G., by being touched with fingers, at some point between the product's removal from the package and its loading onto the guidewire.Subsequently, the thumbwheel was turned in this unlocked state, resulting in the release of the stent.However, due to the lack of specific information regarding the circumstances of this incident, the exact cause could not be determined.Ashitaka factory has been diligently working to ensure the product's quality through the implementation of the following tasks and inspections: 100% inspection to verify that the thumbwheel is in the locked position during the assembly of the deployment handle; 100% visual inspection to confirm that the thumbwheel remains in the locked position after the assembly of the deployment handle.For future use, please take note of the following precautions indicated in the instructions for use (ifu)of the misago product.Preparation of the stent system 2-1: [precautions]: confirm that the stent system is not damaged, and that the sterility has not been compromised.Preparation of the stent system 2-2: confirm that the thumbwheel on the deployment handle is in the "lock" position.

• Brand Name: R2P MISAGO
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomya 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 ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 4103927218
• MDR Report Key: 20627005
• Report Number: 9681834-2024-00197
• Device Sequence Number: 15679985
• Product Code: NIP
• UDI-Device Identifier: 04987350727640
• UDI-Public: (01)04987350727640(17)260930(10)231003
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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): 11/07/2024

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: 09/30/2026
• Device Model Number: SXR08040R
• Device Catalogue Number: SX*FMA0840RN
• Device Lot Number: 231003
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2023
• 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 Sex: Unknown