Noga-Star 120708SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10846835002058), received between Apr 25, 2018 and Feb 22, 2023 — classified as 1 death, 5 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ELECTROMECHANICAL MAPPING ABLATION PROCEDURE WITH A NOGA-STAR¿ CARDIOLOGY CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT A PERICARDIAL EFFUSION WAS NOTED DURING THE CASE AND BEDSIDE ECO WAS DONE TO CONFIRM IT. THEY STATED THAT A PERICARDIOCENTESIS WAS COMPLETED AND THE INITIAL FLUID REMOVAL WAS 350ML. THE PATIENT IS STILL SUFFERING FROM CHEST DISCOMFORT AND IS STILL UNDER OBSERVATION WITH AN OUTPUT OF 5-10ML PER HOUR THE BP IS 103/62 AND HR 103. PROCEDURE: ELECTROMECHANICAL MAPPING AND TRANSENDOCARDIO INJECTION WITH STEM CELLS. HECTOR STUDY. ADDITIONALLY, PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THE PROCEDURE RELATED. NO SURGICAL INTERVENTION REQUIRED. ONLY PERICARDIOCENTESIS AND MEDICAL MANAGEMENT WAS DONE. PATIENT HAS FULLY RECOVERED (NO RESIDUAL EFFECTS). PATIENT WAS ADMITTED ON (B)(6) 2023 AND DISCHARGED ON (B)(6) 2023. THERE WAS NO CARDIAC ABLATION PROVIDED DURING THIS PROCEDURE. NO CONFIRMATION THAT THE STAY WAS CONSIDERED EXTENDED. THEREFORE, ASSESSED AS NO PROLONGED HOSPITALIZATION.

  Patient problems: Cardiac Tamponade

  MAUDE report 16419024 ↗
• InjuryOct 29, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT ((B)(6)) UNDERWENT A 3D NOGA MAPPING AND DURING THE MAPPING PROCEDURE WITH A NOGA-STAR CATHETER, THE PATIENT SUFFERED AORTIC DISSECTION REQUIRING VASCULAR CONSULTATION AND MULTIPLE TESTS. DURING A CLINICAL TRIAL FOR STEM CELL THERAPY, DCMII, AN ADVERSE EVENT OCCURRED. IT WAS REPORTED THAT THIS WAS A TWO-PART PROCEDURE. THE FIRST PART IS A 3D NOGA MAPPING AND DURING THE MAPPING PROCEDURE, THE PATIENT EXPERIENCED A GRADE THREE SEVERE ADVERSE EVENT. THE PATIENT HAD A RETROGRADE DISTAL AORTIC DISSECTION. THE CATHETER WAS ADVANCED AND THE PATIENT STARTED EXPERIENCING PAIN. VASCULAR SURGERY WAS CALLED AND THEY DID AN AORTIC ANGIOGRAM. BASED ON THE ANGIOGRAM, THERE WAS NO COMPROMISE TO THE RENAL PERFUSION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THEIR CONCLUSION WAS THAT THERE WAS A RETROGRADE AORTIC DISSECTION. THE SHEATH WAS WITHDRAWN FROM THE CATHETER AND IT WAS RECOMMENDED THAT THEY CAREFULLY ADVANCE A 5 FR OMNI FLUSH CATHETER (WITH THE PIGTAIL) INTO THE TRUE LUMEN OF THE AORTA USING CINEANGIOGRAPHY. MULTIPLE ANGIOGRAMS WERE TAKEN AND IT WAS CONCLUDED THAT THERE WAS NO COMPROMISE OF RENAL PERFUSION, NONE OF THE CINEANGIOGRAMS SHOWED A

  Patient problems: Vascular Dissection

  MAUDE report 12724623 ↗
• InjuryOct 15, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) / ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) ABLATION PROCEDURE WITH A NOGA-STAR¿ CARDIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE (CT) REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT DURING A PVC/VENTRICULAR TACHYCARDIA ISCHEMIC CASE, A PERICARDIAL EFFUSION WAS NOTICED. THE PERICARDIAL EFFUSION WAS DISCOVERED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE). IT WAS CONFIRMED BY ICE WITH THE SOUNDSTAR ECO CATHETER. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS (IN PROGRESS AT THE TIME OF THE CALL) AND IT WAS UNKNOWN HOW MUCH FLUID WAS REMOVED. THE PATIENT WENT BACK TO THE RECOVERY UNIT. THEY BROUGHT HIM BACK LATER TO PERFORM ANOTHER PERICARDIOCENTESIS BECAUSE THE EFFUSION RE-ACCUMULATED. THERE WERE NO DETAILS ABOUT PATIENT REQUIRING EXTENDED HOSPITALIZATION. IT WAS REPORTED THAT THE PATIENT WENT TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. IT WAS UNKNOWN WHAT CAUSED THE PERICARDIAL EFFUSION. IT WAS REPORTED THAT THE ABLATION CATHETER NEVER ENTERED THE PATIENT¿S BODY. THIS ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN

  Patient problems: Cardiac Tamponade

  MAUDE report 12637972 ↗
• InjuryDec 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INITIALLY THE PATIENT EVENT WAS ONLY REPORTED UNDER THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AS THE NOGA-STAR¿ CARDIOLOGY CATHETER WAS ASSESSED AS A CONCOMITANT PRODUCT. AFTER ADDITIONAL REVIEW ON NOVEMBER 22, 2019, SINCE THE EVENT WAS DISCOVERED DURING USE OF THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND AFTER THE USE OF THE NOGA-STAR¿ CARDIOLOGY CATHETER, THE EVENT WILL BE CONSERVATIVELY REPORTED UNDER BOTH DEVICES. THE RE-ASSESSMENT AWARENESS DATE FOR THE NOGA-STAR¿ CARDIOLOGY CATHETER REPORTABLE DETERMINATION WAS NOVEMBER 22, 2019. IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A NOGA-STAR¿ CARDIOLOGY CATHETER AND DEVELOPED VESSEL PERFORATION. DURING THE PROCEDURE, DURING USE OF THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND AFTER USE OF THE NOGA-STAR¿ CARDIOLOGY CATHETER, AN AORTIC DISSECTION WAS NOTICED. FIRST RETROGRADE ACCESS WAS SUCCESSFUL WITH THE NOGA-STAR¿ CARDIOLOGY CATHETER. NO NEEDLE WAS DEPLOYED. THE PHYSICIAN WAS NOT ABLE TO GAIN ACCESS THE SECOND TIME WITH THE THERMOCO

  Patient problems: Perforation of Vessels

  MAUDE report 9470317 ↗
• InjuryJun 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WITH A NOGA-STAR¿ CARDIOLOGY CATHETER AND SUFFERED VENTRICULAR TACHYCARDIA REQUIRING MEDICATION. DURING THE PROCEDURE, THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA. LIDOCAINE WAS ADMINISTERED, THE CATHETER WAS REPOSITIONED, AND THE CATHETER WAS REMOVED. REMAINDER OF THE PROCEDURE WAS ABORTED. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. SHOULD MORE INFORMATION BECOME AVAILABLE, THE COMPLAINT WILL BE REASSESSED AND NOTES WILL BE UPDATED.

  Patient problems: Ventricular Tachycardia

  MAUDE report 7620659 ↗
• DeathApr 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINALLY, IT WAS REPORTED THAT THE BIOSENSE WEBSTER, INC. DEVICE USED IN THE PROCEDURE WAS THE MYOSTAR. THIS DEVICE HAS NOT BEEN APPROVED BY THE US FDA AND IS NOT MARKETED IN THE U.S, THEREFORE, THIS EVENT WAS ASSESSED AS NOT MDR REPORTABLE UNDER THIS DEVICE. HOWEVER, ON MARCH 28, 2018 ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE NOGA-STAR¿ CARDIOLOGY CATHETER WAS ALSO USED IN THE PROCEDURE. THEREFORE, THIS EVENT IS BEING ASSESSED AS MDR REPORTABLE UNDER THE NOGA-STAR¿ CARDIOLOGY CATHETER WITH THE AWARENESS DATE OF MARCH 28, 2018. IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A NOGA XP-GUIDED INTRA-MYOCARDIAL STEM CELL INJECTION PROCEDURE FOR HEART FAILURE WITH A MYOSTAR INJECTION CATHETER AND A NOGA-STAR¿ CARDIOLOGY CATHETER AND SUFFERED A CARDIAC TAMPONADE (REQUIRING SURGICAL INTERVENTION) AND DEATH. PATIENT WAS PREVIOUSLY ASSIGNED TO THE PLACEBO GROUP OF THE RELATED CLINICAL TRIAL. AFTER OBSERVING THE SIGNIFICANT THERAPEUTIC BENEFITS RECEIVED BY THE TREATMENT GROUP, THE PHYSICIAN CONTACTED THE PATIENT AND OFFERED COMPASSIONATE TREATMENT. PRE-PROCEDURE, ECHOCARDIOGRAPHIC IMAGES WERE OF POOR QUALITY, BUT COMPUTED TOMOGRAPHY (CT) CONFIRMED THE ABSENCE OF A PERICARDIAL

  Patient problems: Cardiac Tamponade; Death; No Code Available

  MAUDE report 7463326 ↗