Cobra PzF 170-03-40015Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00879397000913), received between Apr 13, 2018 and Mar 12, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (3 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.

• 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 25-FEB-2021. UPON UNPACKAGING AND INSPECTING THE RECEIVED UNITS ON 01-MAR-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. THE 4.0X24MM COBRA DEVICE IS BEING REPORTED UNDER MANUFACTURER REPORT NUMBER 3009306400-2021-00001.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11476307 ↗
• MalfunctionMay 24, 2018Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  ON (B)(6) 2018, AN (B)(6)-YEAR-OLD FEMALE PRESENTED WITH ANGINA AND NON-ST-ELEVATED MYOCARDIAL INFARCTION AND DIAGNOSED WITH SINGLE-VESSEL DISEASE IN THE DISTAL RIGHT CORONARY ARTERY (RCA). DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE TO TREAT THE 80% STENOSED, MILDLY CALCIFIED LESION IN THE DISTAL RCA VIA RIGHT FEMORAL ACCESS, AN ATTEMPT WAS MADE TO CROSS THE LESION USING A 4.0X15MM COBRA PZF NANOCOATED CORONARY STENT SYSTEM, WITHOUT PRE-DILATATION, BUT IT WAS UNABLE TO CROSS THE LESION. THE COBRA WAS WITHDRAWN AND THE LESION WAS THEN DILATED USING A 3.0X12MM BALLOON. THE 4.0X15MM COBRA WAS THEN RE-INSERTED, BUT WAS STILL UNABLE TO REACH THE LESION. UPON WITHDRAWAL, IT WAS DISCOVERED THAT THE STENT WAS NOT ON ITS DELIVERY SYSTEM. THE DISLODGED STENT WAS FOUND IN A MILDLY CALCIFIED LESION IN THE PROXIMAL RCA; THOUGH NO TREATMENT WAS PLANNED FOR THIS PROXIMAL RCA LESION, THE COBRA BALLOON WAS RE-ADVANCED TO DEPLOY THE DISLODGED STENT IN THE PROXIMAL RCA, FOLLOWED BY POST-DILATATION WITH THIS SAME BALLOON. THE DISTAL RCA LESION WAS THEN PRE-DILATED AGAIN. A 5.5FR GUIDELINER WAS THEN ADVANCED TO THE PROXIMAL PORTION OF THE DISTAL RCA LESION TO ASSIST WITH CROSSING, FOLLOW

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7542418 ↗
• InjuryApr 13, 2018Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  ON (B)(6) 2018, (B)(6)-YEAR-OLD FEMALE PRESENTED WITH ANGINA AND NON-ST-ELEVATED MYOCARDIAL INFARCTION AND DIAGNOSED WITH SINGLE-VESSEL DISEASE IN THE DISTAL RIGHT CORONARY ARTERY (RCA). DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE TO TREAT THE 80% STENOSED, MILDLY CALCIFIED LESION IN THE DISTAL RCA VIA RIGHT FEMORAL ACCESS, AN ATTEMPT WAS MADE TO CROSS THE LESION USING A 4.0X15MM COBRA PZF NANOCOATED CORONARY STENT SYSTEM, WITHOUT PRE-DILATATION, BUT IT WAS UNABLE TO CROSS THE LESION. THE COBRA WAS WITHDRAWN AND THE LESION WAS THEN DILATED USING A 3.0X12MM BALLOON. THE 4.0X15MM COBRA WAS THEN RE-INSERTED, BUT WAS STILL UNABLE TO REACH THE LESION. UPON WITHDRAWAL, IT WAS DISCOVERED THAT THE STENT WAS NOT ON ITS DELIVERY SYSTEM. THE DISLODGED STENT WAS FOUND IN A MILDLY CALCIFIED LESION IN THE PROXIMAL RCA; THOUGH NO TREATMENT WAS PLANNED FOR THIS PROXIMAL RCA LESION, THE COBRA BALLOON WAS RE-ADVANCED TO DEPLOY THE DISLODGED STENT IN THE PROXIMAL RCA, FOLLOWED BY POST-DILATATION WITH THIS SAME BALLOON. THE DISTAL RCA LESION WAS THEN PRE-DILATED AGAIN. A 5.5FR GUIDELINER WAS THEN ADVANCED TO THE PROXIMAL PORTION OF THE DISTAL RCA LESION TO ASSIST WITH CROSSING, FOLLOWED

  Patient problems: Foreign Body In Patient

  MAUDE report 7429868 ↗