Quick-Cross Extreme Support Catheter 518-086Recalls & reported problems
Spectranetics Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813132021726), received between May 11, 2022 and May 11, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).
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
Device problems
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2022Material Puncture/Hole; Material Puncture/Hole
A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SLIGHTLY CALCIFIED, FIBROUS LESION IN THE PATIENT''S MID POSTERIOR TIBIAL (PT) ARTERY. A SPECTRANETICS QUICK-CROSS SUPPORT CATHETER WAS USED TO CROSS THE LESION. IT WAS REPORTED THAT A PEDAL APPROACH WAS USED. BOTH THE ANTERIOR TIBIAL (AT) AND THE PT ARTERIES WERE SEVERELY TORTUOUS. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE QUICK-CROSS DEVELOPED A HOLE. THE PHYSICIAN DISCONTINUED USE OF THE QUICK-CROSS, ADDITIONAL CATHETERS WERE OPENED, AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE QUICK-CROSS IN WHICH A HOLE WAS OBSERVED DURING USE, POTENTIAL FOR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14366003 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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