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

Catalog Number SX-IMA1060RN

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record and shipping inspection record of the involved product code/lot# combination was conducted with no findings.Ifu states: do not use in highly tortuous or highly calcified lesions and/or vessels proximal to the lesion which could prevent proper pre-dilatation by rolling back the thumb wheel (to spool the traction wires connected to the sliding part), the sliding part is pulled in the proximal direction and the stent starts to get self-expanded.It is likely that the sliding part (stent-mounted part) of the actual sample might have been trapped due to some factors, such as a highly stenosed or tortuous part of the lesion, and resistance was generated when the sliding part in that trapped was being pulled; therefore the thumbwheel could not rotate as in the usual way.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the involved misago was used during the procedure.During stenting in iliac, the thumbwheel could not be rotate as in the usual way.The operator felt something abnormal and stop using it.The procedure was continued with a different-sized product and completed with no problem.The procedure was completed successfully.The patient was not harmed.

• Brand Name: MISAGO
• Type of Device: 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: 11162042
• MDR Text Key: 226545096
• Report Number: 9681834-2020-00266
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: SX-IMA1060RN
• Device Lot Number: 190205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1