Noga-Star 120707SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835002041), received between Jun 4, 2018 and Jan 3, 2022 — classified as 1 death, 1 injury.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathJan 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN (B)(6) MALE PATIENT ((B)(6)) UNDERWENT A CLINICAL TRIAL TO INJECT A STUDY DRUG INTO A MUSCLE IN THE LEFT VENTRICLE WITH A NOGA-STAR¿ CARDIOLOGY CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION AND SUBSEQUENTLY DEATH. THE PATIENT DIED AFTER THE PROCEDURE. THE PATIENT HAD ALREADY MOVED TO THE WARD HOURS EARLIER. NO ABNORMAL OR UNUSUAL SYMPTOMS WERE OBSERVED DURING THE PROCEDURE. MAPPING WAS PERFORMED WITH A NOGA-STAR¿ CARDIOLOGY CATHETER AND DRUG INJECTIONS WITH A MYOSTAR CATHETER. THAT PATIENT WAS PART OF A MULTINATIONAL GENE THERAPY STUDY. CARDIAC TAMPONADE WAS OBSERVED IN THE PATIENT ON ULTRASOUND. AN ULTRASOUND EXAMINATION WAS PERFORMED AS THE PATIENT'S CONDITION WORSENED. THE ADVERSE EVENT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS ABOUT 1.5 HOURS AFTER THE PROCEDURE. MEDICAL INTERVENTION WAS PROVIDED AFTER FIRST SYMPTOMS, TRANSTHORACIC ECHOCARDIOGRAPHY, PERICARDIOCENTESIS, RESUSCITATION, OPEN HEART SURGERY. PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS REPORTED AS PROCEDURE RELATED, NOT BWI PRODUCT MALFUNCTION AND ALSO PATIENT CONDITION RELATED SINCE MYOCARDIUM WAS ABNORMAL; IN

  Patient problems: Cardiac Tamponade

  MAUDE report 13140764 ↗
• InjuryJun 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INTRA-MYOCARDIAL STEM CELL INJECTION PROCEDURE FOR HEART FAILURE WITH A NOGA-STAR¿ CARDIOLOGY CATHETER AND SUFFERED A MYOCARDIAL INFARCTION REQUIRING NO MEDICAL OR SURGICAL INTERVENTION. DURING LEFT HEART CATHETERIZATION, ELEVATED TROPONIN LEVELS WERE CONFIRMED VIA LAB ANALYSIS. THERE WERE NO INTERVENTIONS. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Myocardial Infarction

  MAUDE report 7567973 ↗