MAUDE Adverse Event Report: ACCURATE MEDICAL THERAPEUTICS LTD. SEQURE® MC, 3.0 FR, 155CM

Model Number SQ30_XLB_155

Device Problem Mechanical Problem (1384)

Patient Problems Vasoconstriction (2126); Vascular Dissection (3160)

Event Type  malfunction  

Event Description

This incident was reported by a facility in (b)(6) on (b)(6) 2022.The reporter states that the left uterine artery was the first side attempted with this sequre microcatheter with the beacon tip rbt catheter positioned in the origin of the uterine artery.The microcatheter was unable to navigated mid tortuous segment of that uterine artery.After further attempts the microcatheter buckled out of the uterine artery and after wards the left uterine artery was spasmed and dissected, rendering it no longer viable for embolization from the left side.Reporter states that there was poor trackability within tortuous segment of mid uterine artery, and that the patient was connected and procedure completed with different microcatheter.The contrast agent used in this procedure was isovue 250.

• Brand Name: SEQURE® MC, 3.0 FR, 155CM
• Type of Device: SEQURE® MC, 3.0 FR, 155CM
• Manufacturer (Section D): ACCURATE MEDICAL THERAPEUTICS LTD.; 19 eli hurvitz street; rehovot, 76088 02; IS 7608802
• Manufacturer Contact: gabriel lebovic ; 214 carnegie center, suite 300; princeton, NJ 08540 ; 2153804933
• MDR Report Key: 15614638
• MDR Text Key: 306701849
• Report Number: 3011890588-2022-00004
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SQ30_XLB_155
• Device Lot Number: 21071501
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other