Quick-Cross Support Catheter 518-038Recalls & reported problems
Philips Image Guided Therapy Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813132029388), received between Jun 21, 2023 and Jun 21, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (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 Separation1
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.
InjuryJun 21, 2023Material Separation; Material Separation
A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT SEVERELY CALCIFIED LESIONS IN THE COMMON ILIAC ARTERY. THE PHYSICIAN CHOSE A SPECTRANETICS QUICK-CROSS SUPPORT CATHETER, AND ENTERING FROM A CONTRALATERAL APPROACH, MULTIPLE ATTEMPTS WERE MADE TO CROSS THE LESION, BUT WERE UNSUCCESSFUL. THE CATHETER WAS PULLED BACK FOR REMOVAL; HOWEVER, IT SEPARATED IN THE REGION OF THE PROXIMAL MARKER. ACCESS WAS GAINED ON THE SAME SIDE, AND THE SEPARATED PORTION WAS SUCCESSFULLY RETRIEVED VIA SNARE, WITH NO REPORTED PATIENT HARM. ANOTHER QUICK-CROSS WAS USED TO COMPLETE THE PROCEDURE. THIS REPORT CAPTURES THE QUICK-CROSS WHICH SEPARATED, REQUIRING INTERVENTION FOR RETRIEVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17172987 ↗
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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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