Cardioblate® CryoFlex® 60SF3 (UDI 00763000114626)Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00763000114626), received between Feb 12, 2019 and Nov 27, 2024 — classified as 7 deaths, 33 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 FDA recall record name this device's identifier.

4 other recalls cover devices cleared under the same FDA submission (K123733); they may or may not involve this specific model.

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.

Recalls naming this device

1. Oct 12, 2020Class IITerminated

   There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

   Z-0494-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF MITRAL VALVE REPAIR THROUGH A MINIMALLY INVASIVE PROCEDURE/ THORACOTOMY. DURING THE SAME PROCEDURE ON ((B)(6) 2024) A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY A VALLEYLAB FT-10 GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY CLOSED. LEFT PULMONARY VEIN (LPV) WAS NOT PERFORMED AS IT WAS UNABLE TO BE DONE DUE TO THE THORACOTOMY SURGICAL APPROACH AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WAS SUCCESSFULLY ACHIEVED. ON ((B)(6) 2024) THE PATIENT EXPERIENCED A RIGHT HEMIDIAPHRAGM ELEVATION WHICH WAS NOTED ON THE X-RAY. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CONCOMITANT PROCEDURE BUT UNLIKELY RELATED TO THE STUDY DEVICES AND STUDY PROCEDURE. THE PATIENT'S OUTCOME STATUS WAS RECOVERING/RESOLVING. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE RATIONALE FOR POSSIBLY RELATING THE ADVERSE EVENT TO THE CONCOMITANT PROCEDURE IS DUE TO THE OPENING OF THE RIGHT PERICARDIUM FOR ACCESS TO THE MITRAL VALVE. IT IS UNLIKELY RELATED TO THE STUDY PROCEDURE AS THE SAME APPROACH WAS USED FOR MV. THE RATIONAL FOR THE ADVERSE EVENT BEING UNLIKELY RELATED TO THE CRYO

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 20795172 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF MITRAL VALVE REPAIR. THROUGH A MINIMALLY INVASIVE /THORACOTOMY APPROACH. DURING THE SAME PROCEDURE ON (ON (B)(6) 2024), A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE AND A CARDIOBLATE LP CLAMP POWERED BY A VALLEYLAB FT10 GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY CLOSED. LEFT PULMONARY VEIN CONDUCTION BLOCK (LPV) WAS NOT PERFORMED, DUE TO THORACOTOMY SURGICAL APPROACH AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WAS SUCCESSFULLY ACHIEVED. ON THE ((B)(6) 2024), THE PATIENT EXPERIENCED JUNCTIONAL RHYTHM. THE PATIENT WITH NEW JUNCTIONAL RHYTHM WAS IN THE INTENSIVE CARE UNIT (ICU) AFTER THE INDEX PROCEDURE. ANTIARRHYTHMIC MEDICATIONS WAS BEING HELD, DUE TO IT BEING CONTRAINDICATED WITH JUNCTIONAL RHYTHM. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS NOT RELATED TO THE CONCOMITANT PROCEDURE OR THE STUDY DEVICES AND RELATED TO THE STUDY PROCEDURE. MEDTRONIC RECEIVED, ADDITIONAL INFORMATION, THAT THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CRYOFLEX PROBE, THE STUDY PROCEDURE AND THE CONCOMITANT PROCEDURE. IT WAS STATED, THAT THE ADVERSE EVENT WAS POSSIBLY RELATED TO THE STUDY PROCEDURE, DUE TO

  Patient problems: Arrhythmia

  MAUDE report 20556962 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF MITRAL VALVE REPAIR THROUGH MINIMALLY INVASIVE THORACOTOMY. DURING THE SAME PROCEDURE ON THE (B)(6) 2024) A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY A CARDIOBLATE GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS CLOSED. THE LEFT PULMONARY VEIN (LPV) WAS NOT PERFORMED DUE TO THE THORACOTOMY SURGICAL APPROACH. THE RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WAS SUCCESSFULLY ACHIEVED. ON THE (B)(6) 2024) THE PATIENT EXPERIENCED SINUS NODE DYSFUNCTION. SINUS NODE DYSFUNCTION (BRADYCARDIA) WITH AV BLOCK VS BLOCKED PREMATURE ATRIAL CONTRACTIONS (PACS) WAS NOTED ON TELEMETRY WHILE ADMITTED FROM THE INDEX PROCEDURE. ANTIARRHYTHMIC MEDICATIONS BEING HELD DUE TO CONTRAINDICATION WITH RHYTHM. A PACEMAKER WAS INSERTED. THE PATIENTS OUTCOME STATUS WAS RECOVERING/RESOLVING. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CARDIOBLATE LP CLAMP, THE CRYOFLEX PROBE, THE CONCOMITANT PROCEDURE, THE STUDY PROCEDURE AND THE STUDY DEVICE. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS POSSIBLY RELATED TO THE CARDIOBLATE LP CLAMP, THE CRYOFLEX PROBE AND THE CARDIOBLATE CRYOFLEX CONSOLE AND RELAT

  Patient problems: Arrhythmia

  MAUDE report 20512731 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF AORTIC VALVE REPLACEMENT, CORONARY ARTERY BYPASS GRAFT SURGERY (CABG) THROUGH STERNOTOMY. DURING THE SAME PROCEDURE ON THE (B)(6) 2023) A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY A CARDIOBLATE GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS CLOSED. THE LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE NOT PERFORMED AS THE PATIENT WAS IN ATRIAL FIBRILLATION. ON THE (B)(6) 2024) THE PATIENT EXPERIENCED NON-SUSTAINED VENTRICULAR TACHYCARDIA. ON THE (B)(6) 2024 THE PATIENT OUTCOME STATUS WAS RECOVERED/RESOLVED. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CARDIOBLATE BP2 CLAMP, THE CRYOFLEX PROBE, THE STUDY PROCEDURE, THE CONCOMITANT PROCEDURE AND THE STUDY DEVICE. THE RATIONALE FOR RELATING TO THE CONCOMITANT PROCEDURE: MYOCARDIAL ABLATION DISTURBANCE AND CARDIAC MANIPULATION. THE RATIONALE FOR RELATING THE ADVERSE EVENT TO THE DEVICE: MYOCARDIAL ABLATION INJURY POSSIBLE.

  Patient problems: Tachycardia

  MAUDE report 19631213 ↗
• InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF AORTIC VALVE REPLACEMENT, CORONARY ARTERY BYPASS GRAFT (CABG) THROUGH STERNOTOMY. DURING THE SAME PROCEDURE ON THE ((B)(6) 2023) A CRYOFLEX PROBE AND A CARDIOBLATE LP CLAMP WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY CLOSED. THE LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE NOT PERFORMED AS THE PATIENT WAS IN ATRIAL FIBRILLATION. ON ((B)(6) 2023) THE PATIENT EXPERIENCED COMPLETE HEART BLOCK. THE PATIENT WAS TREATED WITH AN IMPLANTABLE CARDIAC RHYTHM DEVICE. THE PACEMAKER WAS IMPLANTED TO TREAT THE COMPLETE HEART BLOCK THAT THE PATIENT DEVELOPED POST-SURGERY. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS UNLIKELY RELATED TO THE CRYOFLEX PROBE AND THE CARDIOBLATE LP CLAMP, POSSIBLY RELATED TO THE CONCOMITANT PROCEDURE AND THE STUDY PROCEDURE. THE RATIONALE FOR RELATING TO THE CONCOMITANT PROCEDURE IS THAT THE HEART BLOCK IS POSSIBLY RELATED TO ABLATION. THE RATIONALE FOR RELATING TO THE ADVERSE EVENT IS THAT IT IS UNLIKELY RELATED. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS NOT RELATED TO THE CRYOFLEX PROBE, THE CARDIOBLATE CLAMP OR THE STUDY PROCEDURE AND RELATED TO THE CONCOMITANT PROCE

  Patient problems: Heart Block

  MAUDE report 19481094 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF MITRAL VALVE REPAIR AND TRICUSPID VALVE REPAIR THROUGH STERNOTOMY. DURING THE SAME PROCEDURE ON (B)(6) 2023 A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY A CARDIOBLATE GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS AMPUTATED/EXCISED AND OVERSEWN. LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WAS NOT PERFORMED. THE SURGEON ATTEMPTED TO PERFORM CONDUCTION BLOCK TESTING BUT WAS NOT ABLE TO DO SO AS THE PATIENT WAS STILL IN ATRIAL FIBRILLATION.  ON (B)(6) 2023 THE PATIENT EXPERIENCED ATRIAL FLUTTER ON ONE MONTH ELECTROCARDIOGRAM (ECG) STUDY. THE PATIENT STATUS WAS RECOVERING/RESOLVING. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS UNLIKELY RELATED TO THESTUDY DEVICES, STUDY PROCEDURE AND CONCOMITANT PROCEDURE.

  Patient problems: Arrhythmia

  MAUDE report 18739185 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF MITRAL VALVE REPAIR THROUGH A MINIMALLY INVASIVE THORACOTOMY. DURING THE SAME PROCEDURE ON (B)(6) 2022) A CRYOFLEX PROBE POWERED BY A CRYO-CONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY A VALLEY LAB FT-10 GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY SUTURED CLOSED. LEFT PULMONARY VEIN (LPV) CONDUCTION BLOCK WAS NOT PERFORMED (D/T MINIMALLY INVASIVE PORT ACCESS APPROACH) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WAS SUCCESSFULLY ACHIEVED. APPROXIMATELY 15 DAYS POST PROCEDURE (B)(6) 2022) THE PATIENT EXPERIENCED ACUTE INFARCT OF RIGHT PARIETOOCCIPITAL. PATIENT C/O DIZZINESS AND EAR FULLNESS X4 DAYS. SENT TO HOSPITAL BY PCP FOR HEAD CT, IN WHICH RESULTS INDICATED ACUTE INFARCT OF RIGHT PARIETO-OCCIPITAL LOBE. INR THERAPEUTIC. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS NOT RELATED TO THE STUDY DEVICES OR STUDY PROCEDURE, BUT POSSIBLY RELATED TO THE CONCOMITANT PROCEDURE. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR NOT RELATED TO THE STUDY DEVICES, BUT RELATED TO THE STUDY PROCEDURE AND CONCOMITANT PROCEDURE. THE ADVERSE EVENT WAS DEEMED BY THE CEC AS POSSIBLE RELATED TO THE CRYOFLEX PROBE, CARDIOBLATE CLAMP,

  Patient problems: Stroke/CVA

  MAUDE report 18684549 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF MITRAL VALVE REPAIR AND TRICUSPID VALVE REPAIR THROUGH STERNOTOMY. DURING THE PROCEDURE A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY A CARDIOBLATE GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS AMPUTATED/EXCISED AND OVERSEWN. THE LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE NOT SUCCESSFULLY ACHIEVED. THE SURGEON ATTEMPTED TO PREFORM CONDUCTION BLOCK TESTING BUT WAS NOT ABLE TO DO SO AS THE PATIENT WAS STILL IN ATRIAL FIBRILLATION. THE PATIENT EXPERIENCED EDEMA AND A 17 POUND WEIGHT INCREASE FROM BASELINE, ADDITIONAL FUROSEMIDE GIVEN. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS UNLIKELY RELATED TO THE STUDY PROCEDURE, THE CONCOMITANT PROCEDURE AND THE STUDY DEVICES. THE RATIONALE FOR RELATING THE CONCOMITANT PROCEDURE WAS LIKELY DUE TO THE LONGER OPERATION BECAUSE OF TWO HALVES. THE RATIONALE FOR RELATING TO THE STUDY DEVICES WAS DUE TO A LONGER RUN CARDIOPULMONARY BYPASS DUE TO THE TWO HALVES SURGERY. THE PATIENT OUTCOME STATUS IS RECOVERING/RESOLVING.

  Patient problems: Swelling/ Edema

  MAUDE report 18131064 ↗
• MalfunctionNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF MITRAL VALVE REPAIR AND TRICUSPID VALVE REPAIR THROUGH STERNOTOMY. DURING THE PROCEDURE A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY A CARDIOBLATE GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS AMPUTATED/EXCISED AND OVERSEWN. THE LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE NOT ACHIEVED. THE SURGEON ATTEMPTED TO PREFORM CONDUCTION BLOCK TESTING BUT WAS NOT ABLE TO DO SO AS THE PATIENT WAS STILL IN ATRIAL FIBRILLATION. THE PATIENT EXPERIENCED NEW COMPLETE HEART BLOCK AFTER INDEX PROCEDURE. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS UNLIKELY RELATED TO THE STUDY PROCEDURE, THE CONCOMITANT PROCEDURE AND THE STUDY DEVICES. THE RATIONALE FOR UNLIKELY RELATING TO THE STUDY DEVICE AND CONCOMITANT PROCEDURE WAS BECAUSE THE LESIONS WERE NOT IN THE PROXIMITY OF THE AV NODE. THE OUTCOME STATUS OF THE PATIENT IS RECOVERING/RESOLVING.

  Patient problems: Heart Block

  MAUDE report 18129591 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF MITRAL VALVE REPAIR AND TRICUSPID VALVE REPAIR THROUGH STERNOTOMY. DURING THE SAME PROCEDURE A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY A CARDIOBLATE GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS AMPUTATED/EXCISED AND OVERSEWN. THE LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCKS WERE NOT PERFORMED. THE SURGEON ATTEMPTED TO PREFORM CONDUCTION BLOCK TESTING BUT WAS NOT ABLE TO DO SO AS THE PATIENT WAS STILL IN ATRIAL FIBRILLATION. THE PATIENT EXPERIENCED NEW JUNCTIONAL RHYTHM AFTER INDEX PROCEDURE. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS UNLIKELY RELATED TO THE CARDIOBLATE LP CLAMP AND THE STUDY DEVICES AND POSSIBLY RELATED TO THE CRYOFLEX PROBE, THE STUDY PROCEDURE AND THE CONCOMITANT PROCEDURE. THE RATIONALE FOR POSSIBLY RELATING THE ADVERSE EVENT TO THE CONCOMITANT PROCEDURE WAS DUE TO THE MYOCARDIAL EDEMA FROM LESIONS AND DUE TO MYOCARDIAL EDEMA FROM ANNULAR SUTURES. THE RATIONALE FOR UNLIKELY RELATING THE ADVERSE EVENT TO THE STUDY DEVICE WAS DUE TO MYOCARDIAL EDEMA FROM FREEZE LESION. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS RELATED TO THE CRYOFLEX

  Patient problems: Arrhythmia

  MAUDE report 18129377 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF MAZE, LEFT ATRIAL APPENDAGE CLOSURE THROUGH STERNOTOMY. DURING THE SAME PROCEDURE A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY A CARDIOBLATE GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS CLOSED. LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE BOTH SUCCESSFULLY ACHIEVED. THE PATIENT EXPERIENCED FREQUENT PREMATURE VENTRICULAR CONTRACTIONS (PVCS). THE PATIENTS 6 MONTH HOLTER MONITOR SHOWED FREQUENT PVCS. NO INTERVENTION WAS REQUIRED. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE STUDY PROCEDURE, CONCOMITANT PROCEDURE AND THE STUDY DEVICES. THE RATIONALE FOR POSSIBLY RELATING THE ADVERSE EVENT TO THE CONCOMITANT PROCEDURE AND STUDY DEVICES WAS BECAUSE THE POSSIBLE RHYTHM RESIDUAL EFFECT OF ABLATION WAS POSSIBLY RELATED TO THE VALVE RECONSTRUCTION HELIX.

  Patient problems: Arrhythmia

  MAUDE report 18091418 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF AORTIC VALVE REPLACEMENT AND CABG THROUGH STERNOTOMY. ON THE DAY OF THE PROCEDURE A CYROFLEX PROBE AND A CARDIOBLATE BP2 CLAMP WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY CLOSED. LEFT PULMONARY VEIN (LPV) BLOCK WAS NOT PERFORMED. RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WAS NOT PERFORMED. AS PATIENT WAS IN AFIB ON THE SAME DAY, THE PATIENT EXPERIENCED JUNCTIONAL RHYTHM. THE PATIENT WAS TREATED WITH AN IMPLANTABLE JUNCTIONAL RHYTHM DEVICE- PACE MAKER. THIS WAS IMPLANTED DUE TO A COMPLETE HEART BLOCK. THE PATIENT STATUS WAS RECOVERED/RESOLVED. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS RELATED TO THE CONCOMITANT PROCEDURE AND THE STUDY PROCEDURE AND NOT RELATED TO THE STUDY DEVICES. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS POSSIBLY RELATED TO THE CONCOMITANT PROCEDURE, THE STUDY PROCEDURE AND THE STUDY DEVICES. THE RATIONALE FOR RELATING TO THE CONCOMITANT PROCEDURE IS AVR RELATED JUNCTIONAL RHYTHM. THE RATIONALE FOR RELATING TO THE STUDY DEVICE IS ABLATION RELATED TO EDEMA.

  Patient problems: Arrhythmia

  MAUDE report 18072251 ↗
• DeathSep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF AORTIC VALVE REPLACEMENT AND CABG (NUMBER OF ANASTOMOSES: 3) THROUGH STERNOTOMY. THE PATIENT ALSO HAD AN AORTIC ENDARTERECTOMY. DURING THE SAME PROCEDURE A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY A VALLEYLAB FT-10 GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY CLOSED. LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WAS SUCCESSFULLY ACHIEVED. ONE DAY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED MULTISYSTEM ORGAN FAILURE, WHICH WAS TREATED WITH AN IMPLANTABLE PACEMAKER, ADDITIONAL MEDICATION, A RIGHT VENTRICULAR DEVICE, RENAL REPLACEMENT THERAPY, AND A SURGICAL INTERVENTION. THE PATIENT DIED FOUR DAYS LATER. IT WAS REPORTED THAT THE PATIENT CONTINUED TO HAVE INCREASED LACTATE LEVELS POST SURGERY. ON POST-OP DAY 1, A RIGHT VENTRICULAR DEVICE WAS INSERTED. URINE OUTPUT DECREASED OVER NEXT 24 HOURS. POST-OP DAY 2, THEY RECEIVED RENAL REPLACEMENT THERAPY. POST-OP DAY 3, THEY HAD AN EXTERNAL PACEMAKER IMPLANTED FOR LOSS OF UNDERLYING RHYTHM. THE PATIENT CONTINUED TO HAVE INCREASED LACTATE, HYPOTENSION, AND SEVERE PULMONARY EDEMA. THEY HAD WORSENING METABOLI

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Lactate Dehydrogenase Increased; Low Blood Pressure/ Hypotension; Pulmonary Edema

  MAUDE report 17779837 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF MITRAL VALVE REPLACEMENT, TRICUSPID VALVE REPAIR. ON THE DAY OF THE PROCEDURE A CYROFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY AN FT-10 GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY CLOSED. LEFT PULMONARY VEIN (LPV) BLOCK WAS ACHIEVED. RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WAS ACHIEVED. ONE DAY POST PROCEDURE THE PATIENT EXPERIENCED BLEEDING. A CONCOMITANT/ADDITIONAL MEDICATION WAS GIVEN. THE PATIENT WAS TREATED WITH BLOOD TRANSFUSION, SUBJECT WAS OOZY AT END OF CASE, NO ACTIVE BLEEDING, NO NEED FOR VASSOPRESSORS, BLEEDING FROM MOUTH AND TRIALYSIS CATHETER, HEPARIN HELD. H<(>&<)>H REPORTED AS STABLE AT DISCHARGE, NO SIGNS OF ACTIVE BLEEDING. THESE CAUSED PROLONGED HOSPITALIZATION. THE PATIENT STATUS WAS RECOVERED/RESOLVED APPROXIMATELY ONE MONTH LATER AND DISCHARGED FROM HOSPITAL. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS PROBABLY RELATED TO THE CONCOMITANT PROCEDURE, AND NOT RELATED TO THE STUDY PROCEDURE AND NOT RELATED TO THE STUDY DEVICES. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS RELATED TO THE STUDY PROCEDURE AND THE CONCOMITANT PROCEDURE, POSSIBLY RELATED TO THE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17571799 ↗
• InjuryMay 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF AORTIC VALVE REPLACEMENT AND MAZE PROCEDURE THROUGH STERNOTOMY. DURING THE SAME PROCEDURE ON ((B)(6)2022) A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY A VALLEYLAB FT-10 GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY CLOSED AND STAPLED. LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE SUCCESSFULLY ACHIEVED. ON ((B)(6)2023) THE PATIENT WAS FOUND TO HAVE MILD TACHYCARDIA AT THE 3-MONTH VISIT. THE PATIENT WAS PRESCRIBED LOPRESSOR FROM 12.5MG TO 25MG. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CONCOMITANT PROCEDURE, THE STUDY PROCEDURE AND TO THE CRYOFLEX PROBE AND CARDIOBLATE LP CLAMP STUDY DEVICES.

  Patient problems: Tachycardia

  MAUDE report 17016518 ↗
• InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF AORTIC VALVE REPLACEMENT, CORONARY ARTERY BYPASS GRAFTING (CABG), (NUMBER OF ANA STOMOSES: 1) THROUGH STERNOTOMY ON THE (B)(6) 2023. ON THE DAY OF THE PROCEDURE A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY A FT-10 GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE (LAA) CLOSURE WAS AMPUTATED/ EXCISED AND OVER-SEWN. LEFT PULMONARY VEIN (LPV) BLOCK WAS NOT PERFORMED AS THE PRE-PROCEDURE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) COULD NOT RULE OUT THROMBUS IN THE LAA, PATIENT WAS IN ARTERIAL FIBRILLATION AND CARDIOVERSION WAS CONTRAINDICATED DUE TO THIS, IT WAS STATED THAT THEREFORE BLOCK DID NOT NEED TO BE DONE AS SPECIFIED BY CLINICAL REPRESENTATIVE. THE RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WAS ACHIEVED. ON (B)(6) 2023 THE PATIENT EXPERIENCED NEW JUNCTIONAL RHYTHM AFTER THE INDEX PROCEDURE. ANTIARRHYTHMICS WERE STOPPED DUE TO THE JUNCTIONAL RHYTHM. THE PATIENT STATUS IS RECOVERING/RESOLVING THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CONCOMITANT PROCEDURE, UNLIKELY RELATED TO THE STUDY DEVICES AND PROBABLY RELATED TO THE STUDY PROCEDURE. THE SITE PROVIDED THE FOLLOWING RAT

  Patient problems: Arrhythmia

  MAUDE report 16793824 ↗
• DeathMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF MITRAL VALVE REPLACEMENT THROUGH STERNOTOMY ON (B)(6) 2022. ON THE DAY OF THE PROCEDURE A CYROFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP AND CARDIOBLATE ABLATION PEN POWERED BY A CARDIOBLATE GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY CLOSED. LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE ACHIEVED. ON (B)(6) 2022, THE PATIENT EXPERIENCED SEVERE ANEMIA DUE TO CHRONIC AND ACUTE BLOOD LOSS FROM AN UPPER GI BLEED. THE PATIENT WAS HOSPITALIZED ON SAME DATE, AND WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2022. LABS PERFORMED DAILY SHOWED LOW HEMOGLOBIN AND HEMATOCRIT. EGD WAS PERFORMED, 5 UNITS OF PACKED RED BLOOD CELLS WAS TRANSFUSED, AND COUMADIN WAS HELD. THE PATIENT WAS DISCHARGED HOME AND GIVEN PROTONIX. THE PATIENT SUBSEQUENTLY DIED ON (B)(6) 2022. THE DEATH WAS CATEGORIZED AS A NON-CARDIAC DEATH. THE ADVERSE EVENT WAS ASSESSED BY THE SITE AS NOT RELATED TO THE CONCOMITANT PROCEDURE OR THE STUDY PROCEDURE AND NOT RELATED TO THE STUDY DEVICES. THE CLINICAL EVENTS COMMITTEE (CEC) ASSESSED THE ADVERSE EVENT AS NOT RELATED TO THE CONCOMITANT PROCEDURE OR THE STUDY PR

  Patient problems: Anemia

  MAUDE report 16654065 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF AORTIC VALVE REPLACEMENT THROUGH STERNOTOMY ON (B)(6) 2022. ON THE DAY OF THE PROCEDURE A CYROFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY AN FT-10 GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY CLOSED. LEFT PULMONARY VEIN (LPV) BLOCK WAS NOT PERFORMED. RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WAS ACHIEVED. ON (B)(6) 2022 THE PATIENT EXPERIENCED A HEART ATTACK WHICH LED TO PATIENT DEATH ON THE SAME DATE. DEATH CERTIFICATE NOT YET RECEIVED, NO ADDITIONAL INFORMATION. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS UNLIKELY RELATED TO THE CONCOMITANT PROCEDURE AND THE STUDY PROCEDURE AND POSSIBLY RELATED TO THE STUDY DEVICES.

  Patient problems: Cardiac Arrest; Myocardial Infarction

  MAUDE report 16196170 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF AORTIC VALVE REPLACEMENT THROUGH STERNOTOMY ON THE (B)(6) 2022. ON THE DAY OF THE PROCEDURE A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY AN FT-10 GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY STAPLED. LEFT PULMONARY VEIN (LPV) BLOCK AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE ACHIEVED. ON (B)(6) 2022 THE PATIENT EXPERIENCED JUNCTIONAL RHYTHM. PATIENT HAD A NORMAL SINUS RHYTHM (NSR) WHEN THEY LEFT THE OPERATING ROOM AND WAS FOUND TO HAVE JUNCTIONAL RHYTHM THE NEXT TIME THEIR ELECTROCARDIOGRAM (ECG) WAS TAKEN. THE PATIENT WAS TREATED WITH PERCUTANEOUS INTERVENTION AND THEY REQUIRED A TRANSVENOUS PACING WIRE. THE PATIENT STATUS WAS RECOVERED/RESOLVED ON (B)(6) 2022. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CONCOMITANT PROCEDURE, THE STUDY PROCEDURE AND THE CRYOFLEX PROBE AND CARDIOBLATE LP CLAMP STUDY DEVICES. THE ADVERSE EVENT IS NOT RELATED TO THE CRYOCONSOLE STUDY DEVICE. THE FOLLOWING RATIONALE WAS PROVIDED BY THE SITE FOR RELATING THE ADVERSE EVENT TO THE CONCOMITANT AND STUDY PROCEDURES, ABLATION/ CONDUCTION DELAY.

  Patient problems: Arrhythmia

  MAUDE report 16093598 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF MITRAL VALVE REPAIR THROUGH STERNOTOMY. DURING THE SAME PROCEDURE A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE BP2 CLAMP POWERED BY A FT-10 GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY AMPUTATED/EXCISED AND OVERSEWN. LEFT PULMONARY VEIN (LPV) BLOCK WAS ACHIEVED. RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WAS ACHIEVED. ON THE SAME DAY THE PATIENT EXPERIENCED JUNCTIONAL RHYTHM AFTER THE INDEX PROCEDURE. THE PATIENT IS RECOVERING. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CONCOMITANT PROCEDURE, STUDY DEVICES AND STUDY PROCEDURE. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR POSSIBLY RELATED TO THE CONCOMITANT PROCEDURE AND STUDY PROCEDURE BUT NOT RELATED TO THE STUDY DEVICES.

  Patient problems: Arrhythmia

  MAUDE report 15844120 ↗
• InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF CORONARY ARTERY BYPASS GRAFTING THROUGH STERNOTOMY. DURING THE SAME PROCEDURE, A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY AN FT-10 GENERATOR WERE USED. ONE DAY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED JUNCTIONAL BRADYCARDIA REQUIRING TRANSVENOUS PACING. THE PATIENT STATUS WAS RECOVERED/RESOLVED APPROXIMATELY THREE DAYS LATER. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS RELATED TO STUDY PROCEDURE AND CONCOMITANT PROCEDURE BUT NOT RELATED TO STUDY DEVICES. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE STUDY AND CONCOMITANT PROCEDURE AND ALL OF THE STUDY DEVICES.

  Patient problems: Bradycardia

  MAUDE report 15758397 ↗
• DeathOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF MITRAL VALVE REPLACEMENT AND CORONARY ARTERY BYPASS GRAFTING (CABG) WITH 4 ANASTOMOSES THROUGH STERNOTOMY. DURING THE SAME PROCEDURE ON (B)(6) 2022 A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY AN FT-10 GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUTURED CLOSED. LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE ACHIEVED. ON (B)(6) 2022 THE PATIENT EXPERIENCED CARDIAC ARREST AND SUDDEN CARDIAC DEATH. THE PATIENT HAD PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED AND PROPER PROTOCOL WAS FOLLOWED. RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS ACHIEVED BUT ONLY FOR A SHORT PERIOD OF TIME. THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (VFIB) ARREST. THE PATIENT REMAINED PULSELESS. THE TIME OF DEATH OF PATIENT WAS THEN CALLED. THE ADVERSE EVENT WAS DEEMED BY THE SITE CAUSALLY RELATED TO CONCOMITANT PROCEDURE AND STUDY PROCEDURE BUT NOT RELATED TO THE STUDY DEVICES. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS RELATED TO CONCOMITANT PROCEDURE, STUDY PROCEDURE AND CRYOCONSOLE, CARDIOBLATE LP CLAMP AND FT-10 GENERATOR STU

  Patient problems: Atrial Fibrillation; Cardiac Arrest; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 15586132 ↗
• DeathSep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF SEPTAL MYECTOMY AND PAPILLARY MUSCLE RESECTION THROUGH STERNOTOMY. DURING THE SAME PROCEDURE ON ((B)(6) 2022) A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP FT CLAMP POWERED BY A FT-10 GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS CLOSED. LEFT PULMONARY VEIN (LPV) WAS CONDUCTION BLOCK WAS NOT PERFORMED AS THE PATIENT WAS IN CONGENITAL HEART BLOCK (CHB) WITH PACEMAKER. IT WAS STATED THAT IT WAS VERY DIFFICULT TO SEE EXIT BLOCK. RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WAS ACHIEVED. ON THE (B)(6) 2022 THE PATIENT EXPERIENCED SHOCK. THE PATIENT WAS TREATED WITH A TREATED WITH BLOOD TRANSFUSION AND CONCOMITANT/ADDITIONAL MEDICATION WAS GIVEN. THE PATIENT HAD INCREASING VASOPRESSOR REQUIREMENTS AFTER EXTUBATION. THE PATIENT¿S CARDIAC INDEX WAS AT 1.1. WORSENING ACIDOSIS. THE PATIENT HAD ACUTE KIDNEY INJURY WITH ELEVATED CREATININE AND URINARY OUTPUT (UOP) LESS THAN 5 CC/HR. THE PATIENT HAD ACUTE LIVER INJURY WITH ELEVATED BILIRUBIN, ALANINE TRANSAMINASE (ALT), ASPARTATE AMINOTRANSFERASE (AST) AND DECREASED LEVEL OF CONSCIOUS (LOC). THE PATIENT WAS REINTUBATED. BICARB AND FLUIDS WERE GIVEN. TRANSESOPHAGEAL ECHOC

  Patient problems: Shock

  MAUDE report 15402650 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF AORTIC VALVE REPLACEMENT, MITRAL VALVE REPLACEMENT, TRICUSPID VALVE REPAIR THROUGH STERNOTOMY. DURING THE SAME PROCEDURE A CRYOFLEX PROBE POWERED BY A CRYOFLEX CONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY A VALLEYLAB FT-10 GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY CLOSED. LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE ACHIEVED. ON THE SAME DAY AS THE PROCEDURE THE PATIENT EXPERIENCED AN INCREASED BLOOD OUTPUT FROM THE CHEST TUBES (300 ML IN 1 HOUR). IT WAS REPORTED THAT NO PRBCS (PACKED RED BLOOD CELLS) WERE GIVEN AND THE PATIENT WAS SENT TO THE OPERATING ROOM FOR RE-EXPLORATION. NO ACTIVE BLEEDING WAS FOUND AND 200 ML OF BLOOD WAS EVACUATED. 1 UNIT OF PRBC WAS GIVEN SIX DAYS POST PROCEDURE FOR HEMOGLOBIN OF 7.2. THERE WERE NO SIGNS OF ACTIVE BLEEDING. TWO DAYS POST PROCEDURE, THE CHEST TUBES WERE REMOVED AND THERE WERE NO SIGNS OF BLEEDING. THE PATIENT RECOVERED. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS NOT RELATED TO THE STUDY DEVICES OR STUDY PROCEDURE BUT PROBABLY RELATED TO THE CONCOMITANT PROCEDURE. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS RELATED TO THE STUDY

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15346842 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF TRICUSPID VALVE REPAIR THROUGH A MINIMALLY INVASIVE THORACOTOMY. DURING THE SAME PROCEDURE ON ((B)(6) 2022) A CRYOFLEX PROBE AND A CARDIOBLATE LP FT CLAMP POWERED BY A FT-10 GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS CLOSED. LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE NOT PERFORMED. IT WAS STATED THAT THERE WERE MULTIPLE FAILED CARDIOVERSIONS. ON ((B)(6) 2022) THE PATIENT EXPERIENCED PLEURAL EFFUSION. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH INCREASED SHORTNESS OF BREATH FOR TWO DAYS WITH RIGHT UPPER CHEST TIGHTNESS AND INTERMITTENT RIGHT ARM PAIN. THE PATIENT¿S BREATHING WAS WORSE WHEN LYING FLAT. THE PATIENT WAS TREATED WITH CONCOMITANT/ADDITIONAL MEDICATION, THORACENTESIS AND HOSPITALIZATION. THE PATIENT'S STATUS WAS RECOVERED/RESOLVED ON THE (B)(6) 2022. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS NOT RELATED TO THE STUDY DEVICES OR STUDY PROCEDURE AND CAUSALLY RELATED TO THE CONCOMITANT PROCEDURE. THE SITE¿S RATIONALE FOR RELATING TO THE CONCOMITANT PROCEDURE IT THAT IT IS A POST-SURGICAL PROCEDURE COMPLICATION. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS RELATED TO

  Patient problems: Pleural Effusion

  MAUDE report 15165226 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123733. One submission often covers many models, so check the product and lot details in each record.

• Z-0273-2022 · Sep 27, 2021 · Open, Classified
  Cardioblate CryoFlex Surgical Ablation Console
• Z-0495-2021 · Oct 12, 2020 · Terminated
  Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex S
• Z-0496-2021 · Oct 12, 2020 · Terminated
  Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex
• Z-0493-2021 · Oct 12, 2020 · Terminated
  Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposable cryoprobe that is designed for use wit