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

Catalog Number SX-LMA0740LN

Device Problems Material Deformation (2976); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2020

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 the product release decision control sheet of the 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.It is likely that when the actual sample was being advanced through the lesion, the distal tip was caught in it and the sheath was deformed outward, leading to the failure in crossing over the lesion.However, with no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the misago device was used during the procedure.It was a left eia, contralateral approach.An attempt to approach with the destination failed due to its distal tip getting caught in calcified lesion.A few more attempts, after repeated dilatation were not successful, and the actual sample became stuck in the calcified lesion in the fourth trial.It was exchanged since the sliding part became deformed.The procedure was finished successfully.There was no residual in the patient's body, 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: theresa mussaw ; reg. no. 2243441; 950 elkton blvd; elkton, md ; 2837866718
• MDR Report Key: 9853168
• MDR Text Key: 227200207
• Report Number: 9681834-2020-00033
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/19/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: SX-LMA0740LN
• Device Lot Number: 190410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2019
• 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