Embryo transfer catheter devices: a review of adverse event reports to the food and drug administration

With nearly 150,000 embryo transfers performed per year, surveillance of the safety, performance, and quality of embryo transfer catheters (ETCs) is critical. Our objective was to examine and describe adverse events (AEs) associated with ETC devices. We queried the Manufacturer and User Facility Device Experience (MAUDE) database, a voluntary reporting system published by the Food and Drug Administration (FDA) for AEs, which limits data reporting to the past 10 years. ETC devices were identified under product class “Catheter, Assisted Reproduction”. For each AE, information related to the device brand name and manufacturer, the nature of the event, and the nature of the reporter were all tabulated. Each event description was then categorized according to the device problem and subsequent consequence at the patient level. In the interest of presenting data on safety profiles but not generating undue ill will towards a specific product or manufacturer, we have elected to withhold the device and manufacturer name from the specific AE identified. There were 105 AEs identified for ETC in the MAUDE database. Four of these AEs were misclassified as ETC devices and were excluded. All events occurred between 2014 and the present. There were four manufacturers represented by five different products. AEs were reported by the manufacturer in 87% of cases. Device problems were categorized in this study as contamination, packaging problems, malfunction, mechanical problems and material separation. Patient harm was categorized as retained foreign body, malfunction, trauma or failed transfer. Further analysis revealed contamination as the most reported ETC device problem, comprising 68 out of the 101 AEs, which was most often due to oil residue (25 of 68). Other types of contamination were due to the following (n): hair (8), other liquids (11), plastic (2), and dust (2). While one brand of ETC had only 16 total reported AEs, discrepantly 13 of these 16 AEs were due to inappropriate material separations. In contrast, only 3 inappropriate material separation AEs were reported among all other remaining ETCs. Notably, harm to patients occurred in 21.7% of the total reported AEs. Foreign body retention was the most reported patient harm AE (12 of 22), followed by 4 AEs related to tissue trauma (e.g. bleeding, cervical injury). Only 2 AEs were explicitly described to be associated with a failed embryo transfer (e.g. loss or degradation of embryo). Over 10 years, 101 AEs associated with ETCs were voluntarily reported to the FDA, the majority of which were submitted by manufacturers. This likely represents an underestimate of AEs, as reporting rarely occurred by end-users (e.g. physicians, lab staff). Most AEs were related to contamination, and notably 21.7% of AEs led to overt patient harm.