Cobra PzF 170-03-40024Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00879397000937), received between May 3, 2018 and Mar 12, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2021Unstable; Failure to Advance; Material Deformation; Unstable; Failure to Advance; Material Deformation

  DURING PLANNED PERCUTANEOUS CORONARY INTERVENTION (PCI) ATTEMPTS WERE MADE TO CROSS A LESION AT UNSPECIFIED LOCATION WITH A 4.0 X 15MM AND A 4.0 X 24MM COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEMS, BUT BOTH DEVICES WERE UNABLE TO CROSS THE TARGET LESION DUE TO A TORTUOUS AND CALCIFIED VESSEL. THERE WERE NO ADVERSE PATIENT EFFECTS. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED. THE TWO COBRA DEVICES WERE RECEIVED BY CELONOVA RETURNED GOOD LAB ON (B)(6) 2021. UPON UNPACKAGING AND INSPECTING THE RECEIVED UNITS ON (B)(6) 2021, THE COMPLAINTS SPECIALIST NOTED THE FOLLOWING DAMAGE ON BOTH DEVICES: WHILE THE BALLOON WAS TIGHTLY FOLDED AND THE STENT REMAINED CRIMPED ON THE BALLOON, THE STENT WAS DAMAGED AND HAD SHIFTED PAST DISTAL BALLOON MARKER AND DISTAL TIP FOR EACH DEVICE. REVISED: THE 4.0X15MM COBRA DEVICE IS BEING REPORTED UNDER MANUFACTURER REPORT NUMBER 3009306400-2021-00002.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11475966 ↗
• MalfunctionMar 30, 2020Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  SUBSEQUENT TO THE INITIAL FILED MEDWATCH REPORT, USER FACILITY MEDWATCH REPORT WAS RECEIVED AND STATES: DESCRIBE THE EVENT OR PROBLEM: STENT FOUND TO BE REMOVED FROM THE BALLOON WHEN REMOVING THE STENT CATHETER FROM THE PATIENT. THE STENT WAS FOUND IN THE TUOHY ATTACHED TO THE GUIDE CATHETER. STENT WAS RETRIEVED WITHOUT ANY HARM TO PATIENT. PATIENT MONITORED FOR ADVERSE EFFECTS - NO HARM TO PATIENT. WHOLE STENT WAS ABLE TO BE REMOVED FROM PATIENT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : CARDIAC CATHETERIZATION WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY): DEVICE FAILED (E.G. BROKE, COULD NOT GET IT TO WORK OR STOPPED WORKING). NO ADDITIONAL SIGNIFICANT INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9897942 ↗
• InjuryAug 27, 2018Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  ON (B)(6) 2018, A MALE PATIENT PRESENTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). AFTER PRE-DILATING THE MILDLY CALCIFIED, 50% STENOSED LESION IN THE MILDLY TORTUOUS MID RIGHT CORONARY ARTERY (RCA) WITH A 1.5MM BALLOON, A 4.0X24MM COBRA PZF NANOCOATED STENT DELIVERY SYSTEM WAS ADVANCED TOWARD THE LESION WITH RESISTANCE FELT WHEN CROSSING A TIGHT PROXIMAL RCA LESION AND CONTINUED RESISTANCE TO THE MID RCA; WHEN REACHING THE MID RCA LESION THE DEVICE WAS UNABLE TO COMPLETELY CROSS AND THE STENT DISLODGED. THE STENT WAS RETRIEVED BY ADVANCING A SMALLER 1.5MM BALLOON INTO THE STENT, INFLATING THE BALLOON (SLIGHTLY EXPANDING THE STENT), THEN RETRACTING THE STENT INTO THE SHEATH. THE TARGET LESION WAS TREATED WITH A 3.0MM NON-CELONOVA STENT. THERE WERE NO ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7819531 ↗
• MalfunctionMay 3, 2018Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  ON (B)(6) 2018, A MALE PATIENT WITH A KNOWN MEDICAL HISTORY OF BLEEDING PRESENTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED WITH A 3.0MM BALLOON. THE VESSEL WAS THEN SIZED VIA OPTICAL COHERENCE TOMOGRAPHY (OCT) INTRAVASCULAR IMAGING. A COBRA PZF (4.0X15MM) NANOCOATED STENT WAS USED AND WAS UNABLE TO ADVANCE PAST A SHARP BEND IN RCA. THE TREATING PHYSICIAN BELIEVES, THE STENT LENGTH WAS TOO LONG FOR THIS CASE AND A SMALLER SIZE WOULD HAVE BEEN A MORE APPROPRIATE SELECTION. DURING RETRACTION OF THE UNDEPLOYED COBRA SYSTEM OVER THE 014 BMW GUIDE WIRE, RESISTANCE WAS FELT AGAINST THE WIRE, RESULTING IN LOSS OF WIRE POSITIONING; BOTH THE GUIDE WIRE AND COBRA WERE WITHDRAWN FROM THE ANATOMY. THE LESION WAS SUCCESSFULLY TREATED (CONFIRMED VIA OCT) VIA DEPLOYMENT OF TWO SHORTER DRUG-ELUTING STENTS (4.0X8MM AND 4.0X12MM). AFTER THE PROCEDURE WAS CONCLUDED WITHOUT ANY COMPLICATION. IT WAS DISCOVERED THAT THE COBRA STENT WAS NOT ON ITS BALLOON. IMAGING OF THE PATIENT SHOWED NO COBRA STENT IN THE PATIENT; THE STENT WAS ALSO NOT FOUND IN CATH LAB. THEY BELIEVE THE STENT IS LOCATED INSIDE OF THE TUOHY HEMOSTATIC VALVE BUT WAS UNAB

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7483934 ↗