(A103) Adverse Events Associated with the Cook-Swartz Doppler for Free Flap Monitoring - A MAUDE Review

Introduction: Implantable Doppler probes, most commonly Cook Medical's Cook-Swartz probe, are used to monitor blood flow to microvascular free flaps. This study queried the United States Food and Drug Administration’s Manufacturer and User Device Facility Experience (MAUDE) database for reports of adverse events associated with its use.

Methods: The MAUDE database was queried for product code “ITX”, which refers to “Transducer, Ultrasonic, Diagnostic”, and “JOP”, which refers to “Transducer, Ultrasonic.” Additional searches were performed for brand names “Cook-Swartz” and “Doppler probe,” and manufacturer “Cook.” Data was extracted from matching reports including date of event, event type, reporter occupation, device operator, device problem, patient problem due to device, and interventions required.

Results: 58 adverse event (AE) reports filed with MAUDE were identified. After removing reports with insufficient data, 56 reports were analyzed detailing events between August 2015 and March, 2024. The most common AE was loss of Doppler signal requiring return to the operating room (n=22). The second most common AE was fragmentation leading to unintended retention of a portion of the device (n=18), 5 (28%) of which required operative removal. Vascular complications occurred 9 times, most commonly damage to the arterial anastomosis (n=7) during removal of the device requiring revision of the anastomosis. Venous occlusion by the cuff was reported once, as was injury to the venous pedicle. Damaged devices after package opening were reported 4 times. One report details an electric shock sensation which ceased once the device was removed. 32 (65%) of reported AEs required reoperation. Reporter occupation was included in 45 reports with most reporters being either physicians (44%) or other healthcare professionals (22%).

Conclusions: Implantable Doppler probes may aid in monitoring of free flaps, however, this database review demonstrates that they are not without risk with adverse events including vascular compromise, retained foreign body, and loss of signal that may require reoperative intervention.