CARDIOBLATERecalls & reported problems across all models

We found 7 models of CARDIOBLATE by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 65 adverse event reports in the FDA's MAUDE database, received between Dec 18, 2018 and Jun 6, 2025 — classified as 9 deaths, 52 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (2 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. 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

Most reported CARDIOBLATE problems

CARDIOBLATE models

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

• Cardioblate™ 49341

  Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue
  5 deaths35 reports
• CARDIOBLATE® 60841

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  2 deaths9 reports
• CARDIOBLATE® 60831

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  8 reports
• Cardioblate® 6800001AM

  Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue
  1 death6 reports
• CARDIOBLATE® 4920501

  Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue
  1 death4 reports
• Cardioblate™ 49321

  Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue
  2 reports
• CARDIOBLATE® 60814

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

Recent CARDIOBLATE adverse event reports

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

• MalfunctionJun 6, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE CARDIOBLATE PEN COULD NOT IRRIGATE, COULD NOT CONNECT WITH SALINE SOLUTION, IT WAS UNABLE TO CONNECT WITH THE SALINE SOLUTION OR BE PUSHED BY THE CYLINDER. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22156836 ↗
• MalfunctionJan 16, 2025Obstruction of Flow; Obstruction of Flow

  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. THE LEFT PULMONARY VEIN (LPV) AND THE RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK 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. DURING USE OF THE DEVICE SALINE WAS NOT FLOWING THROUGH THE RF LP CLAMP. AFTER PRIMING THE LESION, THREE LESIONS WERE COMPLETED WITH NO ISSUES, AFTER THAT MULIPLE NONTRANSMURAL LESIONS, IT WAS NOTICED THAT THE SALINE WAS NOT ADEQUATELY FLOWING THROUGH THE CLAMP. TROUBLESHOOTING WAS ATTEMPTED AS THE DEVICE WAS HEATING UP TOO QUICKLY SO THE LESIONS WERE NOT TRANSMURAL. THE EVENT WAS DEEMED BY THE SPONSOR AS RELATED TO THE PROCEDURE AND THE CARDIOBLATE LP CLAMP, NOT RELATED TO THE CONCOMITANT PROCEDURE, THE CRYOCONSOLE OR THE CARDIOBLATE CRYOFLEX PROBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21167236 ↗
• 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 20795184 ↗
• 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 20514119 ↗
• 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 20512760 ↗
• 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 THESTUDY DEVICES, STUDY PROCEDURE AND CONCOMITANT PROCEDURE.

  Patient problems: Arrhythmia

  MAUDE report 18739328 ↗
• 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 18684558 ↗
• 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 18396616 ↗
• 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 18131127 ↗
• 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 18129831 ↗
• 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 18129388 ↗
• 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 18091443 ↗
• 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 18072233 ↗
• 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 17779874 ↗
• 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 VASOPRESSORS, 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 CRYOFL

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17571857 ↗

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