HeartLight 18-5000Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00859373007433), received between Aug 19, 2020 and Mar 6, 2025 — classified as 53 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 7, 2025Open, Classified

   Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.

   Z-1307-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, LOSS OF PHRENIC NERVE CAPTURE WAS NOTED WHEN TREATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). PHRENIC ACTIVITY HAD NOT RETURNED BY THE END OF THE PROCEDURE. BECAUSE IT IS UNCLEAR IF A PHRENIC NERVE INJURY OCCURRED THIS EVENT IS BEING REPORTED AS AN MDR.

  Patient problems: Nerve Damage

  MAUDE report 21537980 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION WAS PERFORMED WITHOUT REPORTED INCIDENT. A FEW HOURS AFTER THE PROCEDURE, WHILE IN POST-OP, THE PATIENT EXPERIENCED NUMBNESS IN RIGHT ARM AND HEADACHE. THE SYMPTOMS RESOLVED THE SAME DAY. THE CARE TEAM CONCLUDED UPON EXAMINATION A LIKELY TRANSIENT ISCHEMIC ATTACK (TIA) OR STROKE HAD OCCURRED. IT IS NOT KNOWN IF THIS LIKELY EVENT WAS RELATED TO THE DEVICE OR THE PROCEDURE, BUT A RELATIONSHIP CANNOT BE EXCLUDED.

  Patient problems: Stroke/CVA; Transient Ischemic Attack

  MAUDE report 20789767 ↗
• InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPEAT PROCEDURE TO TREAT ATRIAL FIBRILLATION WAS PERFORMED. WHILE TREATING THE RIGHT INFERIOR PULMONARY VEIN, THE CATHETER WAS INSERTED DEEPER INTO THE VEIN IN AN ATTEMPT TO MAXIMIZE BALLOON TO TISSUE CONTACT. PHRENIC NERVE CAPTURE WAS LOST WHILE ABLATION WAS PERFORMED. OTHER AREAS OF THE VEIN WERE TREATED AND THEN THE CATHETER WAS REMOVED. PHRENIC NERVE CAPTURE WAS RETURNING BY THE END OF THE PROCEDURE. HOWEVER, FEEDBACK WAS RECEIVED APPROXIMATELY 3 WEEKS POST-PROCEDURE THAT THERE WERE STILL SYMPTOMS OF A PHRENIC NERVE INJURY PRESENT AT ONE WEEK POST-PROCEDURE WITH ADDITIONAL FOLLOW-UP TO BE PERFORMED.

  Patient problems: Nerve Damage

  MAUDE report 20604819 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, LOSS OF CAPTURE WAS NOTED WHEN TREATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). CAPTURE WAS NOT REGAINED FOR THE REMAINDER OF THE PROCEDURE. ONE WEEK POST PROCEDURE IT WAS REPORTED THE PATIENT WAS DOING WELL AND THERE WAS NO SHORTNESS OF BREATH. HOWVER, NO TEST OF PHRENIC NERVE FUNCTION WAS PERFORMED. BECAUSE IT IS UNCLEAR IF A PHRENIC NERVE INJURY OCCURRED, AND IF A PHRENIC NERVE INJURY DID OCCUR, IF THE INJURY HAS FULLY RECOVERED, THIS EVENT IS BEING REPORTED AS AN MDR.

  Patient problems: Nerve Damage

  MAUDE report 19037878 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, A PHRENIC NERVE INJURY WAS REPORTED DURING ABLATION OF THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). CAPTURE OF THE PHRENIC NERVE COULD NOT BE ACHIEVED DURING THE REMAINDER OF THE PROCEDURE. CONFIRMATION THE PNI HAD RESOLVED WAS RECEIVED APPROXIMATELY 3 WEEKS POST-PROCEDURE. IT IS UNKNOWN WHEN THE PNI RESOLVED.

  Patient problems: Nerve Damage

  MAUDE report 19037051 ↗
• InjuryJan 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, A PHRENIC NERVE INJURY WAS REPORTED DURING ABLATION OF THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). PHRENIC NERVE CAPTURE WAS UNAVAILABLE FOR THE REMAINDER OF THE PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED FOR THIS REPORTED EVENT.

  Patient problems: Nerve Damage

  MAUDE report 18513265 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, IT WAS INITIALLY BELIEVED THE LEFT SUPERIOR PULMONARY VEIN (LSPV) HAD BEEN ACCESSED. HOWEVER, THE ENDOSCOPIC IMAGE REVEALED TRABECULATIONS AND THE CATHETER TIP APPEARED SLIGHTLY BENT ON FLUOROSCOPY, INDICATING POSSIBLE ENTRY INTO THE LEFT ATRIAL APPENDAGE. THE BALLOON WAS DEFLATED AND ADVANCED INTO WHAT APPEARED TO BE A NOTABLY LARGE VEIN, LATER IDENTIFIED AS A COMMON VEIN. THE BALLOON WAS DEFLATED AGAIN AND INSERTED INTO THE INITIAL STRUCTURE. A DROP IN BLOOD PRESSURE WAS OBSERVED AND PREPARATION FOR PERICARDIOCENTESIS WAS BEGUN FOR SUSPECTED PERICARDIAL EFFUSION. HOWEVER, THE PATIENT'S CONDITION CONTINUED TO WORSEN REQUIRING MULTIPLE ROUNDS OF CHEST COMPRESSIONS. THE PATIENT WAS STABILIZED AND SURGERY WAS PERFORMED TO REPAIR A SMALL TEAR NEAR THE BASE OF THE LEFT ATRIAL APPENDAGE. THE SURGERY WENT WELL, WITH DISCHARGE 3 DAYS POST-PROCEDURE. THE CAUSE OF THE PERFORATION COULD NOT BE DEFINITIVELY DETERMINED BUT MOST LIKELY ATTRIBUTED TO THE ABLATION CATHETER.

  Patient problems: Cardiac Perforation; Cardiac Tamponade

  MAUDE report 17961188 ↗
• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, PHRENIC NERVE CAPTURE WAS LOST WHILE ABLATING THE RIGHT INFERIOR PULMONARY VEIN (RIPV). THE PVI PROCEDURE WAS COMPLETED. AFTER THE PROCEDURE WAS COMPLETED, THE TREATING PHYSICIAN REPORTED POSSIBLE WEAK CAPTURE OF THE PHRENIC NERVE, BUT CONFIRMATION WAS RECEIVED ON (B)(6) 2023 THAT A PHRENIC NERVE INJURY HAD OCCURRED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED FOR THIS REPORTED EVENT.

  Patient problems: Nerve Damage

  MAUDE report 17912658 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, A SMALL PERICARDIAL EFFUSION WAS NOTICED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE). ICE WAS USED AFTER THE TRANSSEPTAL PUNCTURE BUT PRIOR TO ABLATION TO CHECK FOR EFFUSION, WITH NONE FOUND. THE LEFT SUPERIOR PULMONARY VEIN (LSPV) WAS ABLATED WITH NO ISSUES. WHILE MOVING FROM THE LSPV TO THE LEFT INFERIOR PULMONARY VEIN (LIPV) THE TIP OF THE BALLOON CATHETER WAS POSSIBLY INSERTED IN THE LEFT ATRIAL APPENDAGE. AFTER ACCESSING THE LIPV, THE EFFUSION WAS NOTED AS WELL AS A DROP IN BLOOD PRESSURE. PERICARDIOCENTESIS WAS PERFORMED, AFTER WHICH THE EFFUSION WAS NOTED TO BE STABLE.

  Patient problems: Pericardial Effusion

  MAUDE report 17845961 ↗
• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION, THE LEFT-SIDED VEINS WERE TREATED FIRST. THE LEFT SUPERIOR PULMONARY VEIN (LSPV) WAS ABLATED WITHOUT INCIDENT, BUT WHILE ATTEMPTING TO ACCESS THE LEFT INFERIOR PULMONARY VEIN (LIPV) THE CATHETER TIP WENT INTO THE LEFT ATRIAL APPENDAGE BEFORE BEING REPOSITIONED. A GOOD ENDOSCOPIC IMAGE COULD NOT BE OBTAINED IN THE LIPV SO THE CATHETER WAS MOVED TO THE RIGHT-SIDED VEINS. THE PATIENT HAD A HISTORY OF LIPV STENOSIS AND AN EXISTING EFFUSION, SO THE EFFUSION WAS CHECKED AND FOUND TO HAVE WORSENED DURING THE PROCEDURE. PERICARDIOCENTESIS WAS PERFORMED AND THEN REPAIR SURGERY, WHICH FOUND AND REPAIRED A PERFORATION IN THE TIP OF THE LEFT ATRIAL APPENDAGE. THE SURGEON PERFORMING THE REPAIR NOTED THE ATRIAL TISSUE WAS VERY THIN AND FLOPPY AND NOT LIKE TYPICAL ATRIAL TISSUE.

  Patient problems: Cardiac Perforation; Cardiac Tamponade

  MAUDE report 17825142 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INSERTION OF THE CATHETER TO PERFORM A PULMONARY VEIN ISOLATION (PVI) PROCEDURE, THE CATHETER APPEARED TO BE INSIDE THE LEFT ATRIAL APPENDAGE INSTEAD OF A PULMONARY VEIN, WHICH WAS CONFIRMED BY INFLATING THE BALLOON. THE CATHETER WAS REMOVED AND REINSERTED AGAIN INTO THE LEFT ATRIAL APPENDAGE, CONFIRMED BY BALLOON INFLATION. THE CATHETER WAS WITHDRAWN AND INSERTED INTO THE LEFT SUPERIOR PULMONARY VEIN. WHILE ABLATION WAS STARTED, BLOOD PRESSURE DROPPED AND ALL CATHETERS WERE REMOVED. PERICARDIOCENTESIS WAS PERFORMED TO DRAIN EXCESS FLUID BUT SURGERY WAS NEEDED TO REPAIR A PERFORATION IN THE LEFT ATRIAL APPENDAGE. THE PATIENT WAS REPORTED TO BE DOING WELL POST-PROCEDURE.

  Patient problems: Cardiac Perforation; Cardiac Tamponade

  MAUDE report 17817666 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, CARDIAC TAMPONADE WAS NOTICED DUE TO DROP IN BLOOD PRESSURE AND CONFIRMED USING INTRACARDIAC ECHOCARDIOGRAPHY (ICE). ANTICOAGULATION WAS REVERSED USING PROTAMINE AND PERICARDIOCENTESIS WAS PERFORMED. THE TREATING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN THE ABLATION SYSTEM DEVICES AND THE TAMPONADE TO BE UNLIKELY, WITH THE LIKELY CAUSE OF THE TAMPONADE BEING ONE OF THE OTHER CATHETERS (POSSIBLY THE CORONARY SINUS CATHETER) USED IN THE PROCEDURE. THE PROCEDURE WAS STOPPED AND THE PATIENT EXTUBATED. THE EXTUBATION EXAM NOTED NO LEFT ARM MOVEMENT WHICH WAS DIAGNOSED AS A LIKELY STROKE. A COMPUTED TOMOGRAPHY (CT) HEAD SCAN DID NOT SHOW A BLEED. THE RELATIONSHIP BETWEEN THE ABLATION SYSTEM DEVICES AND THE STROKE CANNOT BE CONCLUSIVELY DETERMINED, BUT WAS DEEMED POSSIBLE BY THE TREATING PHYSICIAN.

  Patient problems: Stroke/CVA

  MAUDE report 17795889 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER A SUCCESSFUL PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION ON (B)(6) 2023, THE PATIENT WOKE UP WITHOUT FULL MOVEMENT IN THE LEFT ARM/HAND. A MINOR STROKE WAS DIAGNOSED. THE PATIENT WAS DISCHARGED THE DAY FOLLOWING THE PROCEDURE. FOLLOW-UP INFORMATION WAS RECEIVED ON AUGUST 29, 2023 WHERE THE PATIENT WAS REPORTED AS DOING VERY WELL, ALTHOUGH WITH RESIDUAL EFFECTS FROM THE ADVERSE EVENT. FULL RECOVERY IS EXPECTED AFTER PHYSICAL THERAPY. NO DEVICE DEFICIENCY WAS REPORTED WITH ANY ABLATION SYSTEM DEVICES. THE TREATING PHYSICIAN WAS UNABLE TO DETERMINE IF THERE WAS A RELATIONSHIP BETWEEN THE ADVERSE EVENT AND THE ABLATION SYSTEM DEVICES. BECAUSE THE CAUSE OF THE STROKE CANNOT BE CONCLUSIVELY DETERMINED, THIS EVENT IS BEING REPORTED.

  Patient problems: Stroke/CVA

  MAUDE report 17735983 ↗
• InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, PHRENIC NERVE CAPTURE WAS LOST WHILE ABLATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). PHRENIC NERVE CAPTURE COULD NOT BE REGAINED BY THE END OF THE PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED FOR THIS REPORTED EVENT.

  Patient problems: Nerve Damage

  MAUDE report 17278698 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, PHRENIC NERVE CAPTURE WAS LOST WHILE ABLATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). PHRENIC NERVE CAPTURE COULD NOT BE REGAINED. THE PHYSICIAN REPORTED MILD SHORTNESS OF BREATH APPROXIMATELY 4 WEEKS POST-PROCEDURE, WHICH IS EXPECTED TO RESOLVE.

  Patient problems: Nerve Damage

  MAUDE report 17084091 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, PHRENIC NERVE CAPTURE WAS LOST WHILE ABLATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). PHRENIC NERVE CAPTURE COULD NOT BE REGAINED BY THE END OF THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE THIS REPORTED EVENT.

  Patient problems: Nerve Damage

  MAUDE report 16744502 ↗
• InjuryApr 11, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION IT WAS NOTED THAT ENERGY MAY HAVE BEEN DELIVERED OVER A SMALL VESSEL IN A PULMONARY VEIN. WHEN THE CATHETER'S BALLOON WAS REMOVED IT WAS NOTED THAT SOME CHAR WAS STUCK TO THE BALLOON. FIVE DAYS POST-PROCEDURE THE TREATING PHYSICIAN NOTIFIED THE COMPANY THE PATIENT HAD WOKEN WITH A SLIGHT FACIAL DROOP, WHICH WAS CONFIRMED TO BE A STROKE. THE PATIENT WAS REPORTED TO BE DOING WELL APPROXIMATELY 2 WEEKS POST-PROCEDURE.

  Patient problems: Stroke/CVA

  MAUDE report 16721383 ↗
• InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, BLOOD PRESSURE DROPPED WHILE ATTEMPTING TO POSITION THE CATHETER IN THE RIGHT INFERIOR PULMONARY VEIN (RIPV). INTRACARDIAC ECHOCARDIOGRAPHY (ICE) REVEALED PERICARDIAL EFFUSION WITH EVIDENCE OF CARDIAC TAMPONADE. THE ABLATION DEVICES WERE WITHDRAWN, HEPARIN REVERSED, AND A PERICARDIAL TAP WAS PERFORMED. THE PATIENT IMPROVED WITH CONSERVATIVE MEASURES AND SURGERY WAS NOT REQUIRED. THE CAUSE OF THE CARDIAC TAMPONADE CANNOT BE DEFINITIVELY DETERMINED BUT THE EVENT REPORT INDICATES INVOLVEMENT OF THE ABLATION CATHETER.

  Patient problems: Cardiac Tamponade

  MAUDE report 16603838 ↗
• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, PHRENIC NERVE STIMULATION WAS NO LONGER FELT BY HAND MONITORING WHILE ABLATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). IT WAS REPORTED THE PHRENIC NERVE INJURY RESOLVED FIVE DAYS POST-PROCEDURE, WITH PHRENIC NERVE ACTIVITY CONFIRMED BY CHEST X-RAY. THE PATIENT WAS REPORTED TO BE DOING WELL AFTER RESOLUTION OF THE PHRENIC NERVE INJURY.

  Patient problems: Nerve Damage

  MAUDE report 16563819 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, PHRENIC NERVE CAPTURE WAS LOST AND NOT REGAINED. PHRENIC NERVE CAPTURE HAD NOT RETURNED BY THE END OF THE PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED ABOUT THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 16455738 ↗
• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, PHRENIC NERVE CAPTURE WAS LOST AND NOT REGAINED WHILE TREATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). PHRENIC NERVE INJURY WAS DIAGNOSED WITH A SNIFF TEST AT THE END OF THE PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED ABOUT THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 16387370 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, PHRENIC NERVE PACING WAS LOST WHILE TREATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). CAPTURE COULD NOT BE REESTABLISHED AND THE DIAPHRAGM WAS OBSERVED TO NOT BE MOVING ON FLUOROSCOPY. HOSPITALIZATION WAS NOT EXTENDED AND IT WAS REPORTED ON JULY 28, 2022 THAT WHILE NOT FULLY RECOVERED, THERE WAS MINIMAL SHORTNESS OF BREATH WITH FULL RECOVERY EXPECTED SOON.

  Patient problems: Nerve Damage

  MAUDE report 15252345 ↗
• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, PACING WAS LOST WHILE TREATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). CAPTURE COULD NOT BE REESTABLISHED AND IT WAS NOTED THE DIAPHRAGM WAS NOT MOVING ON FLUOROSCOPY.

  Patient problems: Nerve Damage

  MAUDE report 14939137 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, PHRENIC CAPTURE WAS LOST WHILE ABLATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). AT THE CONCLUSION OF THE CASE THE PHRENIC NERVE COULD NOT BE PACED. DECREASED EXCURSION OF THE RIGHT HEMIDIAPHRAGM WAS OBSERVED UNDER FLUOROSCOPY. AN UPDATE THREE WEEKS POST-PROCEDURE FOUND THE PATIENT ASYMPTOMATIC AND THE PHYSICIAN BELIEVED THE PHRENIC NERVE INJURY HAD RESOLVED.

  Patient problems: Nerve Damage

  MAUDE report 14874169 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, PHRENIC NERVE CAPTURE WAS LOST WHILE ABLATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). AFTER ABOUT 30 MINUTES THE PHRENIC NERVE COULD BE CAPTURED, ALTHOUGH THE CAPTURE WAS REPORTED TO BE WEAK. NO ADDITIONAL FOLLOW-UP INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. IT CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED IF A PHRENIC NERVE INJURY OCCURRED. SINCE PHRENIC NERVE INJURY CANNOT BE COMPLETELY EXCLUDED, THIS CASE IS BEING REPORTED.

  Patient problems: Nerve Damage

  MAUDE report 14874117 ↗