Quick-Cross Support Catheter 518-034Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813132020651), received between Nov 9, 2018 and Mar 6, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2019 A PHILIPS POST MARKET SURVEILLANCE EMPLOYEE RECEIVED THE FOLLOWING USER FACILITY MEDWATCH FROM THE FDA, MEDWATCH MW5083367. DISTAL TIP OF CATHETER BROKE OFF DURING ATTEMPT TO ADVANCE IT. TIP RETRIEVED WITH OUT INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8395001 ↗
• InjuryNov 12, 2018Material Separation; Material Separation

  A PHILIPS REPRESENTATIVE REPORTED THAT DURING A PERIPHERAL ATHERECTOMY PROCEDURE FOR CHRONIC TOTAL OCCLUSION OF THE ANTERIOR TIBIAL ARTERY ABOUT 9CM OF THE QUICKCROSS SUPPORT CATHETER (B)(4) DEVICE BROKE OFF INSIDE THE PATIENT WHEN ATTEMPTING TO CROSS THE LESION. THEY WERE NOT ABLE TO REMOVE THE REMAINING PIECE FROM THE PATIENT. FRAGMENT IS STILL INSIDE THE PATIENT'S VESSEL. NO FURTHER INTERVENTION OR TREATMENT IS PLANNED.

  Patient problems: Device Embedded In Tissue or Plaque; Iatrogenic Source

  MAUDE report 8062418 ↗
• MalfunctionNov 9, 2018Material Separation; Material Separation

  A (B)(6) REPRESENTATIVE REPORTED THAT WHEN PREPPING THE SPECTRANETICS QUICK-CROSS SUPPORT CATHETER 518-034 FOR USE IN A PERIPHERAL ATHERECTOMY PROCEDURE THE PHYSICIAN WANTED TO EXCHANGE A CORDIS SV-5 .018 GUIDEWIRE DOWN TO A .014 WIRE. THE QUICK-CROSS WAS HANDED OFF, FLUSHED BY THE SCRUB NURSE, AND PUT ON THE WIRE. HE ADVANCED THE QUICK-CROSS UP THE WIRE SO THE PHYSICIAN COULD REACH IT AND THEN THE PHYSICIAN TOOK CONTROL OF ADVANCING THE CATHETER. AFTER A FEW CENTIMETERS THE CATHETER GOT STUCK ON THE WIRE. THEN THE PHYSICIAN TOLD THE SCRUB NURSE TO REMOVE THE CATHETER OFF THE WIRE. AS THE NURSE WAS TAKING IT OFF IT SNAPPED LEAVING A SHORT SEGMENT OF THE DISTAL TIP ON THE WIRE. THE BROKEN PIECE WAS THEN REMOVED OFF THE WIRE WITHOUT ANY PROBLEMS. A DIFFERENT TYPE OF CATHETER WAS USED TO COMPLETE THE EXCHANGE. ALL THIS HAPPENED WITHIN 100CM OF THE BACK END OF THE 300CM WIRE. IT NEVER ENTERED THE PATIENT AND IT DIDN¿T CAUSE LOSS OF GUIDEWIRE POSITION. NO HARM TO PATIENT. PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8057655 ↗