Rotarex

Description of Event or Problem

On (b)(6), 2026, a patient underwent a thrombectomy and atherectomy procedure using a Rotarex device for peripheral arterial disease. After approximately 10 cm of rotational atherectomy, the device was withdrawn for flushing. Upon reinsertion for further treatment and advancement of approximately 5 cm, it was discovered that the tip of the Rotarex catheter had fractured and remained lodged in the distal portion of the superficial femoral artery. The operator promptly and safely retrieved the fractured catheter tip using biopsy forceps through an 8F long sheath without causing harm to the patient. The procedure was completed using another device. There was no reported patient injury.

Additional Manufacturer Narrative

H11: The catalog number identified in Section D4 has not been cleared in the US but is similar to the Rotarex that are cleared in the US. The PRO Code and 510 K number for the Rotarex are identified in D2 and G4.As the lot number for the device was provided, a review of the Device History Records is currently being performed. The device has not been returned to the manufacturer for evaluation. However, Photo and Image were provided for review. The investigation of the reported event is currently underway.Section A through F: The information provided by BD represents all the known information at this time. Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to BD.