Crosser iQ Ultrasonic
Received Jul 27, 2026 · Event occurred Jul 3, 2026
Report 2020394-2026-01915 · MDR key 50021307
Device
Generic name
Recanalization Catheter
Manufacturer
Bard Peripheral Vascular, Inc.Catalog number
XCTO146
Lot number
GFKW1467
Product problems
- Detachment of Device or Device Component
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
On (b)(6) 2026, a patient underwent a recanalization procedure using the Crosser IQ catheter. During the procedure, the catheter tip was allegedly detached rendering the device inoperable. The current status of the patient is unknown.
Additional Manufacturer Narrative
H11: This report was impacted by eMDR scheduled maintenance occurring July 22, 2026 to July 27, 2026. As the lot number for the device was provided, a review of the Device History Records was performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (IFU) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow up report will be submitted as applicable. Section A through F: The information provide 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.