Cardioblate CryoFlexRecalls & reported problems across all models

We found 8 models of Cardioblate CryoFlex by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 77 adverse event reports in the FDA's MAUDE database, received between Dec 18, 2018 and Jul 15, 2025 — classified as 9 deaths, 61 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

5 FDA recall records name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Cardioblate CryoFlex recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 27, 2021Open, Classified

   There is potential for intermittent electrical connectivity between the console and probe.

   Z-0273-2022 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

2. Oct 12, 2020Terminated

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

   Z-0496-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Oct 12, 2020Terminated

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

   Z-0495-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Oct 12, 2020Terminated

   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 ↗

5. Oct 12, 2020Terminated

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

   Z-0493-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Cardioblate CryoFlex problems

Cardioblate CryoFlex models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Cardioblate® CryoFlex® 60SF3

  Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue
  1 recall7 deaths41 reports
• Cardioblate® CryoFlex® 60SF2

  Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue
  1 recall13 reports
• Cardioblate® CryoFlex® 65CS1

  Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue
  1 recall1 death11 reports
• Cardioblate® CryoFlex® 65CS1

  Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue
  1 recall1 death6 reports
• Cardioblate® CryoFlex® 60SF7

  Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue
  1 recall1 report
• Cardioblate® CryoFlex® 60CM1

  Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue
  1 recall0 reports
• Cardioblate® CryoFlex® 60SF2

  Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue
  4 reports
• Cardioblate® CryoFlex® 60SF3

  Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue
  1 report

Recent Cardioblate CryoFlex adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING MANUAL BENDING PRIOR TO USE, THE COILED WIRE OF THE CRYOFLEX PROBE BECAME DAMAGED AND DETACHED WHILE SHAPING THE TIP OF THE DEVICE TO MATCH THE LESION. THE ISSUE WAS IDENTIFIED IMMEDIATELY AS A DEVICE DEFECT BEFORE PATIENT USE, AND THE PRODUCT WAS REMOVED FROM THE STERILE FIELD. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505452 ↗
• 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 ON THE (B)(6) 2024. ON THE DAY OF THE PROCEDURE A CYROFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BYAN 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) 2024, THE PATIENT EXPERIENCED PROLONGED QTC. PROLONGED QTC INTERVAL NOTED ON ECG DURING INDEX PROCEDURE HOSPITALIZATION. THE PATIENT STATUS IS DOWN AS RECOVERING/ RESOLVING THE ADVERSE EVENT WAS DEEMED BY THE SITE AS UNLIKELY RELATED TO THE CONCOMITANT PROCEDURE, STUDY PROCEDURE OR THE STUDY DEVICES. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS RELATED TO THE CONCOMITANT PROCEDURE AND THE STUDY PROCEDURE, BUT POSSIBLY RELATED TO THE STUDY DEVICES.

  Patient problems: Arrhythmia

  MAUDE report 20514027 ↗
• 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 REL

  Patient problems: Arrhythmia

  MAUDE report 20512744 ↗
• 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 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 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 THE (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 THE STUDY DEVICES, STUDY PROCEDURE AND CONCOMITANT PROCEDURE.

  Patient problems: Arrhythmia

  MAUDE report 18739263 ↗
• 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 ↗
• MalfunctionDec 27, 2023Adverse 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 GRAFT (CABG) THROUGH STERNOTOMY. DURING THE SAME PROCEDURE ON THE (B)(6) 2023) A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, A CARDIOBLATE MAPS MODEL 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 THERIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE SUCCESSFULLY ACHIEVED. ON THE (B)(6) 2023) THE PATIENT EXPERIENCED VENTRICULAR PREMATURE CONTRACTIONS (VPCS). THE ERT HOLTER REPORT SHOWED FREQUENT VPCS, MORE THAN THIRTY IN ONE HOUR. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS UNLIKELY RELATED TO THE CONCOMITANT PROCEDURE, THE STUDY PROCEDURE AND THE STUDY DEVICES. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS NOT RELATED TO THE CONCOMITANT PROCEDURE, THE STUDY PROCEDURE AND THE STUDY DEVICES.

  Patient problems: Arrhythmia

  MAUDE report 18396634 ↗
• MalfunctionDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE EVENT WAS DELETED FROM THE DATABASE WITH FOLLOWING COMMENT: "THIS IS A PRE-EXISTING CONDITION AND NOT WORSENING."

  Patient problems: Arrhythmia

  MAUDE report 18396626 ↗
• 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 18131080 ↗
• 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 ↗

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