Quick-Cross Support Catheter 518-037 (UDI 00813132029371)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813132029371), received between Oct 23, 2023 and Feb 2, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATHERECTOMY PROCEDURE COMMENCED TO TREAT A CALCIFIED LESION. A PHILIPS QUICK-CROSS SUPPORT CATHETER WAS USED TO TREAT THE PATIENT. DURING REMOVAL OF THE QUICK-CROSS FROM THE PATIENT, THE PROXIMAL MARKER BAND WAS DISCOVERED TO BE OVERLAPPING WITH THE MIDDLE MARKER BAND. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION, WHICH CAPTURES THE QUICK-CROSS MARKER BANDS THAT DETACHED BUT REMAINED ON DEVICE, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636893 ↗
• InjuryOct 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE DISTAL COMMON FEMORAL ARTERY (CFA). A PHILIPS QUICK-CROSS SUPPORT CATHETER WAS ADVANCED SUBINTIMALLY (WITHIN THE SUBINTIMAL LAYER OF THE ARTERY) AND BECAME STUCK. THE CATHETER WAS PULLED AND THE TWO MOST DISTAL MARKER BANDS DETACHED FROM THE SHAFT, RESULTING IN EMBOLISM. THE MARKER BANDS COULD NOT BE RETRIEVED; THEREFORE, A STENT WAS USED TO TACK THE MARKER BANDS WITHIN THE VESSEL WALL. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE QUICK-CROSS MARKER BANDS WHICH DETACHED WITHIN THE PATIENT REQUIRING INTERVENTION, BUT UNABLE TO BE RETRIEVED.

  Patient problems: Foreign Body Embolism

  MAUDE report 17987701 ↗