MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number	SXR07100R
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: supplies tech.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Review of the manufacturing record and the shipping inspection record of the involved product/lot# combination confirmed that there were not any indications of anomaly in them.In the deployment handle assembly process of the involved product, when each material (thumbwheel, spring [mechanism for unlocking the thumbwheel], release wire and anti-kinking sleeve) is assembled with each other, it is confirmed with the image device if each material is properly installed, and the image records are kept in storage.Review of all image record of the involved product/lot# combination confirmed that there were not any indications of anomaly in them.In the shipping inspection of involved product, it is confirmed that the thumbwheel of deployment handle can be unlocked.Review of the inspection record of the involved product/lot# combination confirmed that there were not any indications of anomaly in them.A search of the complaint file found no other similar report with the involved product/lot# combination from other facilities.Based on reviewing records, no anomaly was found in the manufacturing record and the shipping inspection record.Since the actual sample was not returned, the event described in this complaint could not be confirmed, and the cause of occurrence could not be clarified.Ashitaka factory is continuing diligence in maintaining the product quality by performing thorough operations and inspections, for example as follows.In the deployment handle assembly process of the involved product, when each material (thumbwheel, spring [mechanism for unlocking the thumbwheel], release wire and anti-kinking sleeve) is assembled with each other, it is confirmed with the image device if each material is properly installed, and the image records are kept in storage.In addition, the ifu has the following description.Grasp the deployment handle firmly and depress the thumbwheel until it clicks.(b)(4).
Event or Problem Description
The user facility reported that the misago thumb wheel was jammed on the device.Since the device was contaminated the device was discarded.This occurred pre-treatment.The device never went into the patient's body.There were no issues.The case was successful.Patient condition was fine.The procedure outcome was excellent.Misago specific information: the artery of the lower extremity was not previously treated.Location was the sfa (superficial femoral artery).Diseased limb, right sfa.There were no calcifications or tortuosity.Other equipment or devices were used with the involved product.Additional information was received on 09november2021: they used another stent, second same device, with no issues (to complete stenting as described).Patient was stable, case successful.The thumbwheel lock could not be pushed in to create the mechanism to be released.The thumbwheel was unable to be clicked, rotated.Nothing was jammed in the gap between the handle and the thumbwheel.The only issue was the thumbwheel would not unlock.

• Brand Name: R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: 12879751
• Report Number: 9681834-2021-00192
• Device Sequence Number: 11999347
• Product Code: NIP
• UDI-Device Identifier: 04987350727626
• UDI-Public: 04987350727626
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P140002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2021

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: 10/31/2021
• Device Catalogue Number: SXR07100R
• Device Lot Number: 181127
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 11/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2018
• 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: Male