ONE SNARE®
Received Jul 27, 2022 · Event occurred Jun 1, 2022
Report 9616662-2022-00015 · MDR key 15114710
Device
Generic name
Device, Percutaneous Retrieval
Manufacturer
Merit Medical System IrelandModel number
00884450094877Catalog number
ONE1001
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Female
- Stroke/CVA
- Myocardial Infarction
- Great Vessel Perforation
- Stroke/CVA
- Myocardial Infarction
- Great Vessel Perforation
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
ACCORDING TO PMCF DATA, AN ACCOUNT ALLEGES THAT WHILE RETRIEVING A STENT, FROM THE PERIPHERAL VASCULATURE, OF AN ADULT FEMALE, THE PATIENT EXPERIENCED - STROKE, MYOCARDIAL INFARCTION, AND VESSEL PERFORATION; HOWEVER, NO ADDITIONAL TREATMENT WERE REQUIRED. NO ADDITIONAL DETAILS AVAILABLE.
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE IDENTIFIED. SHOULD THE DEVICE BE RETURNED LATER, THE INVESTIGATION WILL BE RE-OPENED.