Coseal Spray Set 0600021Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00085412087788), received between Jun 14, 2023 and Jul 2, 2024 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FIVE DAYS PRIOR TO THE RECEIPT OF THIS REPORT, THE PATIENT UNDERWENT A THORACOTOMY (PULMONARY ARTERY BANDING) PROCEDURE WHEREIN COSEAL SPRAY SET WAS APPLIED. THREE DAYS LATER THE PATIENT DEVELOPED A TWO-STAGE PULSE ARRHYTHMIA UPON AWAKENING. ANALGESIA WAS ADDED AND THE PATIENT WAS MONITORED. CIRCULATION WAS STABLE. TWO DAYS LATER SEDATION WAS TERMINATED AND THE TWO STAGE PLUSE DID NOT REOCCUR. THE FOLLOWING DAY THE PATIENT WAS TRANSFERRED TO A GENERAL MEDICAL UNIT. AN ECHOCARDIOGRAM WAS PERFORMED, AND A SMALL AMOUNT OF PERICARDIAL FLUID WAS FOUND AROUND THE ENTIRE CIRCUMFERENCE OF THE HEART. DIASTOLIC DIMENSION IS LESS THAN 1MM. TWO DAYS AFTER THAT, A FOLLOW UP ECHOCARDIOGRAM WAS PERFORMED, AND A PERICARDIAL EFFUSION WAS OBSERVED AROUND THE ENTIRE HEART. THE DIASTOLIC DIMENSION WAS ABOUT 7 MM, WHICH HAD RAPIDLY INCREASED COMPARED TO THE DAY BEFORE YESTERDAY. EMERGENCY DRAINAGE WAS PERFORMED. A MEDIAN SUBCUTANEOUS INCISION OF ABOUT 4 CM WAS MADE TO REACH THE PERICARDIAL SAC AT THE DIAPHRAGMATIC PLANE, RESULTING IN A CLEAR RED PALE BLOODY PERICARDIAL EFFUSION. THE PERICARDIAL EFFUSION DRAINED APPROXIMATELY 35 ML. SINCE THERE WAS NO PERSISTENT BLEEDING IN THE PERICARDIAL SAC, A 15FR D

  Patient problems: Cardiac Tamponade

  MAUDE report 19657699 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A PULMONARY ARTERY BANDING WHEREIN COSEAL SURGICAL SEALANT WAS APPLIED UTILIZING EASYSPRAY AND COSEAL SPRAY SET. THE PATIENT WAS ADMITTED TO THE PEDIATRIC INTENSIVE CARE UNIT. FOUR DAYS POSTOPERATIVE (POSTOP) AN ECHOCARDIOGRAM WAS PERFORMED, AND NO ABNORMALITIES WERE NOTED. BOTH THE INTRAPERICARDIAL AND MEDIASTINAL DRAINS WERE REMOVED. THE PATIENT WAS TRANSFERRED TO A GENERAL MEDICAL PEDIATRIC UNIT IN ¿STABLE CONDITION.¿ THE FOLLOWING DAY, AT 0100 SERUM EXUDATE WAS OBSERVED ORIGINATING FROM THE WOUND. TWO HOURS LATER, AN ECHOCARDIOGRAPHY SHOWED A SMALL AMOUNT OF PERICARDIAL FLUID ALL AROUND THE WOUND. THERE WAS A ¿POSSIBILITY OF LEAKING FLUID FROM THE SUTURE GAP IN THE WOUND;¿ HOWEVER, THE WOUND EDGE WAS NOT BROKEN OPEN AND WAS TEMPORARILY PROTECTED WITH A DRESSING AND FILM.¿ PREDONINE WAS STARTED AS ¿PERICARDIAL FLUID THERAPY.¿ SEVEN HOURS LATER, AN ECHOCARDIOGRAPHY SHOWED INCREASED PERICARDIAL EFFUSION AROUND THE ENTIRE CIRCUMFERENCE (DIASTOLIC 1.5-2.0 MM, SYSTOLIC 3.5 MM [UP TO 6 MM IN SOME AREAS]). SIX AND HALF HOURS LATER THE ECHOCARDIOGRAPHY WAS REEVALUATED, AND THE DETERIORATION WAS ASSESSED. THE PATIENT WAS DIAGNOSED WITH CARDIAC TAMPONADE DUE TO PERIC

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 19071185 ↗
• InjuryApr 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A MITRAL VALVE REPAIR AND PULMONARY ARTERY BANDING FOR AN ATRIOVENTRICULAR SEPTAL DEFECT WHEREIN COSEAL SURGICAL SEALANT, EASYSPRAY, AND COSEAL SPRAY SET WERE UTILIZED. FIVE DAYS POST OPERATIVE (POST-OP) A PERICARDIAL EFFUSION WAS REPORTED (NO FURTHER INFORMATION CONVEYED). TWENTY-TWO DAYS POST-OP THE PATIENT EXPERIENCED A FEVER (NOT FURTHER SPECIFIED). DAY TWENTY-THREE POSTOP, A HEAR COMPUTED TOMOGRAPHY SCAN (CT SCAN) WAS PERFORMED AND IT REVEALED SUSPECTED UPPER MEDIASTINAL ABSCESS. THIS SAME DAY UNSPECIFIED ANTIBIOTICS WERE INITIATED. FORTY-SEVEN DAYS POST-OP THE PATIENT HAD RECOVERED FROM THE POSTOPERATIVE MEDIASTINITIS. THE ANTIBIOTIC THERAPY WAS CONTINUED AS ¿PROPHYLACTIC ADMINISTRATION¿. PERICARDIAL EFFUSION OUTCOME WAS NOT REPORTED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Abscess; Pericardial Effusion

  MAUDE report 19060174 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PEDIATRIC PATIENT UNDERWENT OPEN HEART SURGERY WHEREIN COSEAL SURGICAL SEALANT WAS APPLIED VIA AN EASYSPRAY DEVICE WITH COSEAL SPRAY SET. FIVE DAYS POST OPERATIVE (POSTOP) THE PATIENT HAD AN ECHOCARDIOGRAPH AND CONFIRMED PERICARDIAL EFFUSION. THAT SAME DAY THE PATIENT STARTED ON UNSPECIFIED MEDICATIONS FOR TREATMENT OF THE PERICARDIAL EFFUSION. THE NEXT DAY, A SECOND ECHOCARDIOGRAPH WAS PERFORMED, AND NO IMPROVEMENT WAS NOTED. THE PATIENT UNDERWENT A PERICARDIAL DRAINAGE PROCEDURE, AND A DRAINAGE DUCT WAS PLACED. THE PATIENT WAS HOSPITALIZED THE SAME DAY. EIGHT DAYS POSTOP THE PATIENT HAD RECOVERED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pericardial Effusion

  MAUDE report 18939266 ↗
• InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TETRALOGY OF FALLOT PATIENT UNDERWENT A BLALOCK-TAUSSIG SHUNTING SURGERY IN WHICH COSEAL SPRAY SET WAS USED. IT WAS REPORTED SEVEN DAYS POST-OPERATIVE THE PATIENT EXPERIENCED MEDIASTINITIS. THE PATIENT WAS TREATED WITH VANCOMYCIN. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bacterial Infection; Inflammation

  MAUDE report 17129466 ↗