Cardioblate™ 49341Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00643169998018), received between Oct 23, 2020 and Jan 16, 2025 — classified as 5 deaths, 28 injuries, 2 malfunctions.

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

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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

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

  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 PATIENT STATUS IS RECOVERING/RESOLVING. 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 AND NOT RELATED TO THE CRYOCONSOLE AND VALLEYLAB FT-10 GENERATOR.

  Patient problems: Tachycardia

  MAUDE report 17016523 ↗
• 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 16793857 ↗
• 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: Myocardial Infarction

  MAUDE report 16196278 ↗
• InjuryJan 16, 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 THROUGH STERNOTOMY ON (B)(6) 2022. ON THE DAY OF THE PROCEDURE A CYROFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE BP2 CLAMP POWERED BY AN 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 (B)(6) 2022 THE PATIENT EXPERIENCED PAUSES. THE PATIENT HAD 2 BACK TO BACK PAUSES TOTALING 6.8 SECONDS, NOTED ON THE NON-MEDTRONIC PATCH PROVIDER PRESCRIBED. THE ON CALL PHYSICIAN WAS ALERTED TO THIS AND CALLED THE SUBJECT. THE SUBJECT WAS ASYMPTOMATIC AND SLEEPING AT TIME OF EVENT. SUBJECT WAS ADVISED TO GO BACK AND RESUME WHAT THEY WERE DOING PRIOR. THE PATIENT STATUS WAS RECOVERING/ RESOLVING. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CONCOMITANT PROCEDURE AND THE STUDY PROCEDURE AND POSSIBLY RELATED TO THE CARDIOBLATE BP2 CLAMP. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS CAUSALLY RELATED TO THE CONCOMITANT PROCEDURE AND THE STUDY PROCEDURE AND NOT RELATED TO THE STUDY DEVICES.

  Patient problems: Arrhythmia

  MAUDE report 16173953 ↗
• InjuryJan 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, ASCENDING AORTA REPLACEMENT, MAZE, LEFT ATRIAL APPENDAGE (LAA) LIGATION 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 STAPLED. LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE ACHIEVED. 21 DAYS LATER, ON (B)(6) 2022 THE PATIENT EXPERIENCED ATRIAL FLUTTER. THE PATIENT CAME IN DURING THEIR 1 MONTH VISIT AND WAS FOUND TO BE IN ATRIAL FLUTTER. THE ADVERSE EVENT WAS TREATED WITH MEDICATION, PERCUTANEOUS INTERVENTION AND EXTERNAL CARDIOVERSION. THREE DAYS LATER, THE PATIENT RECOVERED. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS RELATED TO THE CONCOMITANT PROCEDURE, STUDY PROCEDURE AND THE CRYOCONSOLE BUT NOT REL ATED TO THE CRYOFLEX PROBE, CARDIOBLATE LP CLAMP OR THE FT-10 GENERATOR. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CONCOMITANT PROCEDURE, STUDY PROCEDURE AND THE CRYOFLEX PROBE, C ARDIOBLATE LP CLAMP BUT NOT RELATED TO THE CRYOCONSOLE OR THE FT-10 GENERATOR.

  Patient problems: Atrial Flutter

  MAUDE report 16112640 ↗
• 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 16093614 ↗
• InjuryDec 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 AORTIC VALVE REPLACEMENT, ASCENDING AORTA REPLACEMENT, MAZE AND LEFT ATRIAL APPENDAGE (LAA) LIGATION PROCEDURE THROUGH STERNOTOMY. DURING THE SAME PROCEDURE ON (B)(6) 2022 A CRYOFLEX PROBE POWERED BY A CRYO-CONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY AN FT-10 GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS STAPLED. LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE ACHIEVED. PATIENT HAD BEEN IN JUNCTIONAL RHYTHM DURING THE PROCEDURE AND SWITCHED TO VENTRICULAR PACED RHYTHM, THE NEXT DAY ON (B)(6) 2022. PATIENT SWITCHED BACK TO JUNCTIONAL RHYTHM AND STAYED THAT WAY FOR 5 DAYS UNTIL (B)(6) 2022.  EVENT WAS TREATED WITH MEDICATION AND PERCUTANEOUS INTERVENTION. THE PATIENT RECOVERED. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS NOT RELATED TO THE CRYOFLEX PROBE, CARDIOBLATE LP CLAMP OR FT-10 GENERATOR AND RELATED TO THE STUDY PROCEDURE, CONCOMITANT PROCEDURE AND CRYO-CONSOLE INSTRUMENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO CONCOMITANT PROCEDURE, STUDY PROCEDURE, CRYOFLEX PROBE, AND THE CARDIOBLATE LP CLAMP.

  Patient problems: Arrhythmia

  MAUDE report 16033041 ↗
• InjuryNov 29, 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 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. THE LEFT ATRIAL APPENDAGE WAS STAPLED. LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE ACHIEVED. 6 DAYS LATER, THE PATIENT EXPERIENCED A TACHYBRADYCARDIA. A SINUS RHYTHM WITH FIRST-DEGREE AV BLOCK WAS NOTED FOR A PERIOD OF TIME, THE PATIENT CONTINUED TO HAVE INTERMITTENT PERIODS OF JUNCTIONAL RHYTHM. THE EP WAS CONSULTED AFTER TWO DAY, THE PATIENT UNDERWENT A PERMANENT PACEMAKER (PPM) USING A MEDTRONIC DUAL CHAMBER PACEMAKER WITH LEFT BUNDLE BRANCH AREA PACING. THERE WAS NO INTRA PROCEDURAL COMPLICATIONS. THEY DID NOT OBSERVED SINUS NODE FUNCTION SINCE SURGERY, NOTED ON POST-OP DAY 5. THE SINUS NODE WAS POSSIBLY INJURED DURING THE SURGERY. POST-OP, THE PATIENT HAD BEEN IN JUNCTIONAL RHYTHM RATE OF 40S TO 50S WITH OCCASIONAL RARE SINUS BEAT. THE PATIENT WAS RECOVERED/RESOLVED 1 DAY POST PPM. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLE RELATED TO THE STUDY DEVICES, STUDY PROCEDURE AND CONCOMITANT PROCEDURE.

  Patient problems: Bradycardia

  MAUDE report 15876275 ↗
• 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 15844087 ↗
• 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 15758426 ↗
• DeathOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 STUDY DEVICES. THE CLINICAL EVENTS COMMITTEE (CEC) DEEMED CAUSALLY RELATED TO CONCOMITANT PROCEDURE, STUDY PROCEDURE AND POSSIBLY RELATED TO ALL OF THE STUDY

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

  MAUDE report 15586159 ↗
• 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 ECHOCAR

  Patient problems: Shock

  MAUDE report 15402697 ↗
• 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 15346907 ↗