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- W4377015988 abstract "The Needle's Eye Snare (Cook Medical, Bloomington, IN) is a transvenous grasping device intended for percutaneous retrieval of foreign objects, including CIED leads, broken lead fragments, indwelling catheters, and guide wires. We sought to assess the type of adverse events (AE) associated with the Needle's Eye Snare during transvenous lead extraction using the FDA Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database is a repository of industry and patient/physician-reported medical device adverse events. A MAUDE database search was conducted on November 10, 2022, for reports received between January 2012 to October 2022 to capture all adverse events Seventy events were inlcuded after the exclusion of duplications. Of this, 94.3% (n=66 events) had no identified device problem, while 5.6% (n=4) were related to device malfunction (4.3%, three events - device break, 1.4%, 1 event - device failed to grab leads). The most common complications were injury/perforation of cardiac chambers (27.1%, 19 events), followed by injury/perforation to superior vena cava or adjacent veins (14.3%, 10 events), innominate artery injury (2.9%, 2 events), hemothorax (2.9%, 2 events), intra-cardiac thrombosis (2.9%, 2 events), and pulmonary embolism (2.9%, 2 events). Thoracotomy was required in 57.1% (40 events, 39 events from pericardial effusion, 1 event from intra-cardiac thrombosis), and pericardiocentesis was required in 34.3% (24 events). Death was reported in 15.7% (11 events). This study highlights the post-FDA approval real-world safety profile of the Needle's Eye Snare used for transvenous lead extraction. Our study is limited by significant heterogeneity in event reporting, lack of accurate assessment of the total number of cases performed using this device (thus not allowing assessment of incidence), and integrity of data reported in the MAUDE database." @default.
- W4377015988 created "2023-05-19" @default.
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- W4377015988 date "2023-05-01" @default.
- W4377015988 modified "2023-09-26" @default.
- W4377015988 title "PO-02-062 ADVERSE EVENTS ASSOCIATED WITH NEEDLE’S EYE SNARE DURING TRANSVENOUS LEAD EXTRACTION: A FOOD AND DRUG ADMINISTRATION MAUDE DATABASE STUDY" @default.
- W4377015988 doi "https://doi.org/10.1016/j.hrthm.2023.03.855" @default.
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