Cobra PzF 170-03-40012Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00879397000906), received between Nov 15, 2017 and Nov 15, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2017Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2017, AFTER PRE-DILATING THE A MODERATELY CALCIFIED LESION IN THE PROXIMAL CIRCUMFLEX CORONARY ARTERY, A 4.0 X 12 MM COBRA PZF STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION. THE COBRA SDS WAS WITHDRAWN, AND ADDITIONAL PRE-DILATATION WAS PERFORMED. THE SAME COBRA SDS WAS RE-INSERTED, BUT UPON EXITING THE GUIDE CATHETER (EBU 3.5), IT WAS NOTED THAT THE STENT WAS NO LONGER ON THE BALLOON. ALL DEVICES WERE WITHDRAWN AS A SINGLE UNIT AND THE STENT CAME OUT ALONG WITH THE DEVICES; THE STENT HAD DISLODGED AT SOME POINT WHILE ENTERING PATIENT VASCULATURE. NO FORCE WAS APPLIED AT ANY TIME WHILE USING THE COBRA SDS. A 3.5 MM COBRA PZF SUCCESSFULLY CROSSED AND THE STENT WAS DEPLOYED. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7035450 ↗