ENSNARE ONE SNARE®
Received Nov 17, 2022 · Event occurred Feb 2, 2022
Report 9616662-2022-00020 · MDR key 15812079
Device
Product problems
- Off-Label Use
- Adverse Event Without Identified Device or Use Problem
- Off-Label Use
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WHILE REVIEWING PMCF DATA IT WAS ALLEGED THAT A VASCULAR SNARE DEVICE WAS USED WITHIN THE CARDIOVASCULAR SYSTEM. THE DEVICE USE WAS OFF LABEL PER IFU. A PERFORATION WAS NOTED DURING A VASCULAR PROCEDURE. SURGICAL INTERVENTION AND CUT DOWN WAS REQUIRED TO REMOVE THE FOREIGN BODY FROM THE PATIENT. THE PHYSICIAN ALLEGES THAT THE EVENT HAS BEEN REPORTED TO THE MEDICAL MANUFACTURER.
Additional Manufacturer Narrative
THE SUSPECT DEVICE IDENTIFIED WITHIN THE REPORT WILL NOT BE RETURNING FOR INVESTIGATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY AND COMPLAINT DATABASE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED. SHOULD THE DEVICE BE RETURNED AT A LATER DATE, THE INVESTIGATION WILL BE RE-OPENED.