Quick-Cross Support Catheter 518-036 (UDI 00813132020675)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00813132020675), received between Oct 10, 2019 and Jun 12, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2023Material Separation; Material Separation

  PHILIPS BECAME AWARE ON 18MAY2023 VIA A USER FACILITY REPORT (B)(4)) OF A PERIPHERAL ATHERECTOMY PROCEDURE WHICH COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE PATIENT''S COMMON FEMORAL ARTERY (CFA). A SPECTRANETICS QUICK-CROSS SUPPORT CATHETER WAS USED TO CROSS THE LESION. DURING USE, THE QUICK-CROSS BROKE WITHIN THE ARTERY. THE BROKEN PORTION WAS RETRIEVED WITH A SNARE, REMOVING THE DEVICE IN ITS ENTIRETY. A STENT WAS PLACED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THE PHYSICIAN BELIEVED THAT SEVERE ARTERY STENOSIS CAUSED THE QUICK-CROSS TO SEPARATE. THIS REPORT CAPTURES THE QUICK-CROSS WHICH SEPARATED, REQUIRING INTERVENTION FOR RETRIEVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17111423 ↗
• InjuryOct 14, 2022Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A LESION IN THE PATIENT''S LEFT ANTERIOR TIBIAL (AT) ARTERY. THE PHYSICIAN CHOSE A SPECTRANETICS QUICK-CROSS SUPPORT CATHETER TO TREAT THE PATIENT. DURING USE, THE QUICK-CROSS DEVICE SEPARATED IN THE AREA OF THE LESION. THE PHYSICIAN USED A SNARE TO SUCCESSFULLY RETRIEVE THE SEPARATED PORTION FROM THE AT REGION. THE PROCEDURE WAS COMPLETED WITH A NEW QUICK-CROSS CATHETER WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE QUICK-CROSS FOR SHAFT SEPARATION, REQUIRING INTERVENTION FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15609424 ↗
• InjurySep 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE PATIENT'S PROXIMAL ILIAC ARTERY. A SPECTRANETICS QUICK-CROSS SUPPORT CATHETER WAS USED TO TREAT THE PATIENT. DURING THE PROCEDURE, THE DISTAL PORTION OF THE CATHETER BROKE OFF INSIDE THE PATIENT AND WAS UNABLE TO BE RETRIEVED. THE DISTAL PORTION WAS STENTED TO THE VESSEL WALL TO PREVENT MOVEMENT WITHIN THE VASCULATURE. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE QUICK-CROSS CATHETER WHICH SEPARATED INSIDE THE PATIENT, REQUIRING INTERVENTION BUT UNABLE TO BE RETRIEVED.

  Patient problems: Foreign Body Embolism

  MAUDE report 15495753 ↗
• InjuryJun 22, 2022Break; Break

  THE INTENDED PROCEDURE WAS AN ATHERECTOMY, WITH BILATERAL PELVIC AND LEFT LOWER EXTREMITY RUNOFF VIA ANGIOGRAPHY. DURING THE PROCEDURE, THE PHYSICIAN CHOSE A QUICK-CROSS SUPPORT CATHETER TO TREAT THE PATIENT. UPON MOVING THE QUICK-CROSS WITHIN THE PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA), IT WAS NOTED THAT A PORTION OF THE CATHETER HAD BROKEN OFF (APPROXIMATELY 10 CM LONG). IN ORDER TO REMOVE FROM THE PATIENT, THE INTRODUCER SHEATH WAS UPSIZED FROM A 5F TO A 6F, THE GUIDE WIRE WAS REMOVED, AND A 10 MM SNARE WAS INSERTED INTO THE LEFT ILIAC ARTERY. THE CATHETER PORTION WAS SUCCESSFULLY SNARED AND REMOVED. THE PATIENT DID NOT FEEL DISCOMFORT AND THERE WAS NO REPORTED PATIENT HARM. FURTHER ATTEMPTS FOR ATHERECTOMY WERE ABORTED. THIS REPORT CAPTURES THE QUICK-CROSS FOR SHAFT SEPARATION, REQUIRING INTERVENTION FOR REMOVAL.

  Patient problems: Foreign Body Embolism

  MAUDE report 14783650 ↗
• InjuryOct 28, 2020Break; Break

  A PHILIPS REPRESENTATIVE REPORTED THAT A PERIPHERAL VASCULAR PROCEDURE COMMENCED AND PHYSICIAN WAS REPORTEDLY USING A SPECTRANETICS QUICK-CROSS SUPPORT CATHETER TO TREAT THE PATIENT. THE REPRESENTATIVE WAS NOT PRESENT DURING THE PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE'S TIP REPORTEDLY BROKE OFF. IT WAS ALSO REPORTED THAT THE PATIENT WAS SCHEDULED TO HAVE SUBSEQUENT SURGERY TO REMOVE THE DEVICE'S TIP. THE PATIENT REPORTEDLY SURVIVED THE PROCEDURE. IT IS UNKNOWN WHETHER THE DEVICE IS BEING RETURNED TO THE MANUFACTURER FOR EVALUATION. MULTIPLE ATTEMPTS HAVE BEEN MADE FROM A PHILIPS REPRESENTATIVE TO THE PHYSICIAN IN ORDER TO OBTAIN MORE INFORMATION ABOUT THE PROCEDURE AND DETAILS OF THE ALLEGED MALFUNCTION; NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10748173 ↗
• InjuryOct 10, 2019Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  A PHILIPS REPRESENTATIVE REPORTED DURING A PERIPHERAL ATHERECTOMY PROCEDURE, THE CATHETER SNAPPED IN TWO WITHIN THE PATIENT. PATIENT HAD PREVIOUS BILATERAL ILIAC ARTERY STENTS AND THE RIGHT SIDE EXTENDED INTO THE AORTA. THE QUICK CROSS CATHETER BECAME "HUNG" ON THE RIGHT SIDE STENT EDGE (NOT IN THE STENT STRUCTURE) WHEN PHYSICIAN WAS REMOVING IT. WITH LEFT SIDE COMMON FEMORAL ARTERY (CFA) ACCESS, THE PHYSICIAN WAS ABLE TO SNARE THE WIRE FROM RIGHT SIDE INTO LEFT SHEATH, PLACED 5FR 90 CM DILATOR ONTO WIRE, AND PUSHED REMAINING QUICK CROSS CATHETER OUT OF LEFT SIDE CFA SHEATH. THE PHYSICIAN WAS ABLE TO REMOVE ALL PARTS WITHOUT ANY ISSUE AND ANOTHER SPECTRANETICS QUICK CROSS SUPPORT CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9175103 ↗