HeartLight 18-2531-N250Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00868976000109), received between Aug 30, 2018 and Apr 29, 2022 — classified as 1 death, 64 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (4 reports).

1 other recall cover devices cleared under the same FDA submission (P150026); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED OF PULMONARY VEIN (PV) STENOSIS AFTER A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION. STENOSIS OF THE RIGHT SUPERIOR PULMONARY VEIN (RSPV) OF 80% TO 90% WAS REPORTED. THE EXACT PROCEDURE DATE WAS NOT REPORTED BUT WAS PRIOR TO (B)(6) 2020. TREATMENT BY DILATING THE PV WITH A BALLOON WAS REPORTED TO BE PLANNED BUT NO ADDITIONAL INFORMATION ON PATIENT STATUS COULD BE OBTAINED.

  Patient problems: Stenosis

  MAUDE report 14250050 ↗
• InjuryApr 20, 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 PALSY WAS CONFIRMED WHILE ABLATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). AT THE END OF THE PROCEDURE, CAPTURE OF PHRENIC NERVE PACING WAS CONFIRMED BY PALPATION. SLIGHT ELEVATION OF THE RIGHT SIDE OF THE DIAPHRAGM WAS OBSERVED BUT THERE WERE NO SIGNS OF AGGRAVATION AND THE PATIENT WAS DISCHARGED WITHOUT PROLONGATION OF HOSPITALIZATION. SINCE SLIGHT ELEVATION OF THE DIAPHRAGM WAS OBSERVED, THIS EVENT IS BEING REPORTED.

  Patient problems: Nerve Damage

  MAUDE report 14162824 ↗
• InjurySep 16, 2021Adverse 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 DECREASE IN COMPOUND MAPPING ACTIVATION POTENTIAL (CMAP) AMPLITUDE OCCURRED WHILE ABLATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). PHRENIC NERVE CAPTURE WAS ALSO LOST. IT WAS REPORTED THAT DIAPHRAGMATIC PARALYSIS HAD NOT RECOVERED AT COMPLETION OF THE PROCEDURE. NO OTHER INFORMATION WAS RECEIVED, SO IT IS UNKNOWN IF DIAPHRAGMATIC FUNCTION RECOVERED PRIOR TO PATIENT DISCHARGE.

  Patient problems: Nerve Damage

  MAUDE report 12482362 ↗
• InjuryJun 4, 2021Adverse 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 DECREASE IN COMPOUND MAPPING ACTIVATION POTENTIAL (CMAP) AMPLITUDE WAS NOTICED WHILE ABLATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). THE PROCEDURE WAS COMPLETED WITH NO OTHER ISSUES, BUT LOSS OF PHRENIC NERVE CAPTURE WAS STILL CONFIRMED FOLLOWING THE COMPLETION OF PVI. IT CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED IF A PHRENIC NERVE INJURY OCCURRED. SINCE THE INFORMATION RECEIVED WAS INCOMPLETE AND PHRENIC NERVE INJURY CANNOT BE COMPLETELY EXCLUDED, THIS CASE IS BEING REPORTED.

  Patient problems: Nerve Damage

  MAUDE report 11942704 ↗
• InjuryMay 20, 2021Adverse 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 DECREASE IN COMPOUND MAPPING ACTIVATION POTENTIAL (CMAP) AMPLITUDE WAS NOTICED WHILE ABLATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). DESPITE THE DECREASED CMAP AMPLITUDE, PHRENIC NERVE CAPTURE WAS CONFIRMED BY PACING. THE CMAP AMPLITUDE WAS UNCHANGED THROUGOUT THE REMAINDER OF THE PROCEDURE. BECAUSE OF COVID RESTRICTIONS NO FURTHER UPDATES ABOUT THIS CASE COULD BE OBTAINED. IT CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED IF A REPORTABLE SERIOUS INJURY OCCURRED SINCE IT WAS REPORTED THAT PHRENIC NERVE CAPTURE WAS POSSIBLE WITH NO ADDITIONAL INFORMATION RECEIVED. SINCE THE INFORMATION RECEIVED WAS INCOMPLETE AND SERIOUS PHRENIC NERVE INJURY CANNOT BE COMPLETELY EXCLUDED, THIS CASE IS BEING REPORTED.

  Patient problems: Nerve Damage

  MAUDE report 11859947 ↗
• InjuryApr 29, 2021Adverse 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 INJURY WAS DIAGNOSED BY DECREASE IN COMPOUND MAPPING AMPLITUDE POTENTIAL (CMAP) AMPLITUDE WHILE ABLATING THE RSPV. THE PROCEDURE WAS COMPLETED WITH THE PHRENIC NERVE SHOWING NO RECOVERY. NO ADDITIONAL INFORMATION WAS AVAILABLE SO IT IS NOT KNOWN IF THE PHRENIC NERVE INJURY PERSISTED BEYOND DISCHARGE.

  Patient problems: Nerve Damage

  MAUDE report 11749889 ↗
• InjuryDec 30, 2020Adverse 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 DIAPHRAGMATIC CAPTURE WAS CONFIRMED BY PALPATION DURING ABLATION OF THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). ADDITIONAL PHRENIC NERVE PACING WAS PERFORMED FROM THE SUPERIOR VENA CAVA BUT THERE WAS NO DIAPHRAGMATIC CAPTURE. AT THE END OF THE PROCEDURE DIAPHRAGMATIC PARALYSIS WAS CONFIRMED BY FLUOROSCOPY. THE PATIENT DID NOT HAVE ANY SYMPTOMS AND WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Nerve Damage

  MAUDE report 11097631 ↗
• InjuryDec 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED OF GASTRIC DILATION ON X-RAY FOLLOWING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION. THE PATIENT WAS DISCHARGED BUT LATER BEGAN HAVING SYMPTOMS OF ABDOMINAL DISTENSION WHICH WERE MEDICALLY TREATED WITH SUCCESSFUL RESOLUTION APPROXIMATELY FOUR MONTHS POST-ONSET. THE TREATING PHYSICIAN BELIEVES THE GASTRIC DILATION IS PROBABLY RELATED TO THE PVI PROCEDURE.

  Patient problems: Nerve Damage

  MAUDE report 11027209 ↗
• InjuryDec 2, 2020Adverse 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 DIAPHRAGMATIC CAPTURE WAS LOST DURING ABLATION OF THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). LOSS OF RIGHT SIDE DIAPHRAGMATIC MOTION WAS CONFIRMED WITH FLUOROSCOPY. NO ADDITIONAL INFORMATION ON THIS EVENT IS AVAILABLE.

  Patient problems: Nerve Damage

  MAUDE report 10936513 ↗
• InjuryNov 4, 2020Adverse 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, REDUCTION IN THE DIAPHRAGMATIC RESPONSE WAS CONFIRMED BY PALPATION AND COMPOUND MUSCLE ACTIVATION POTENTIAL (CMAP) AMPLITUDE WHILE ABLATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). THIS REDUCTION IN MOTION OF THE DIAPHRAGM WAS CONFIRMED WITH FLUOROSCOPY. SUBSEQUENTLY IT WAS REPORTED THAT SIGNIFICANT IMPROVEMENT BUT NOT FULL RESOLUTION OF THE DIAPGRAGMATIC MOVEMENT HAD BEEN OBSERVED AND THE PATIENT HAD BEEN RELEASED WITHOUT PROLONGATION OF HOSPITALIZATION.

  Patient problems: Nerve Damage

  MAUDE report 10787948 ↗
• InjuryOct 16, 2020Adverse 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 DIAPHRAGMATIC CAPTURE WAS CONFIRMED FROM A DECREASE IN COMPOUND MUSCLE ACTION POTENTIAL (CMAP) AMPLITUDE WHILE ABLATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). PHRENIC NERVE PACING WAS PERFORMED BUT THERE WAS NO DIAPHRAGMATIC RESPONSE. FLUOROSCOPY WAS PERFORMED 30 MINUTES POST-PROCEDURE AND THE PARALYSIS WAS STILL PRESENT. SOME DIAPHRAGMATIC MOTION WAS OBSERVED BUT IT COULD NOT BE IDENTIFIED IF THE VISIBLE MOVEMENT WAS BECAUSE OF THE MOTION OF THE LEFT HEMIDIAPRAGHM. THE PATIENT WAS DISCHARGED WITHOUT SYMPTOMS OR PROLONGATION OF HOSPITALIZATION.

  Patient problems: Nerve Damage

  MAUDE report 10691385 ↗
• InjurySep 23, 2020Adverse 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, THE DIAPHRAGMATIC RESPONSE TO PACING WAS REDUCED. THE PACING CATHETER WAS REPOSITIONED AND ABLATION WAS CONTINUED BUT LOSS OF DIAPHRAGMATIC CAPTURE OCCURRED AND ELEVATION OF THE DIAPHRAGM WAS OBSERVED. THE PVI PROCEDURE WAS CONTINUED AND THE DIAPHRAGM GRADUALLY DESCENDED BUT THE REACTION TO PACING WAS STILL DIFFERENT BETWEEN THE TWO SIDES OF THE DIAPHRAGM. IT IS UNKNOWN IF THE PATIENT HAD FULLY RECOVERED BY THE TIME OF DISCHARGE AND ATTEMPTS TO GET ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL BECAUSE OF RESTRICTIONS IN PLACE DUE TO COVID-19. IT CANNOT BE DETERMINED IF THE PHRENIC NERVE INJURY PERSISTED WITH THE INFORMATION REPORTED SO AN MDR IS BEING SUBMITTED.

  Patient problems: Nerve Damage

  MAUDE report 10576501 ↗
• InjurySep 4, 2020Adverse 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 DIAPHRAGMATIC CAPTURE WAS CONFIRMED FROM A DECREASE IN COMPOUND MUSCLE ACTION POTENTIAL (CMAP) AMPLITUDE WHILE ABLATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). THE DIAPHRAGMATIC PARALYSIS WAS STILL PRESENT AT THE END OF THE PROCEDURE. THE PATIENT WAS DISCHARGED WITHOUT SYMPTOMS OR PROLONGATION OF HOSPITALIZATION, BUT ELEVATION OF THE DIAPHRAGM WAS CONFIRMED ON PRE-DISCHARGE CHEST X-RAY.

  Patient problems: Nerve Damage

  MAUDE report 10497097 ↗
• InjurySep 4, 2020Adverse 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 DECREASE IN DIAPHRAGMATIC REACTION TO PALPATION WAS NOTICED WHILE ABLATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). THE DIAPHRAGMATIC PARALYSIS WAS STILL PRESENT AT THE END OF THE PROCEDURE AND LOSS OF DIAPHRAGMATIC CAPTURE WAS OBSERVED WHEN PACING. THE PATIENT WAS DISCHARGED WITHOUT SYMPTOMS OR PROLONGATION OF HOSPITALIZATION BUT THE DIAPHRAGM WAS SLIGHTLY ELEVATED. A FOLLOW-UP VISIT ON OR BEFORE AUGUST 24, 2020 NOTED CONTINUED ELEVATION OF THE DIAPHRAGM ON X-RAY ALTHOUGH THERE WERE SIGNS OF IMPROVEMENT.

  Patient problems: Nerve Damage

  MAUDE report 10497077 ↗
• InjurySep 3, 2020Adverse 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 DECREASE IN COMPOUND MUSCLE ACTION POTENTIAL (CMAP) AMPLITUDE WAS NOTICED AND DIAPHRAGMATIC PARALYSIS WAS CONFIRMED ON THE FLUOROSCOPIC IMAGE WHILE ABLATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). THE DIAPHRAGMATIC PARALYSIS WAS STILL PRESENT AT THE END OF THE PROCEDURE. THE PATIENT WAS DISCHARGED WITHOUT SYMPTOMS OR PROLONGATION OF HOSPITALIZATION, BUT THE CONDITION OF THE DIAPHRAGM WAS UNKNOWN AT THE TIME OF DISCHARGE, SO IT IS POSSIBLE THE PHRENIC NERVE INJURY WAS STILL PRESENT.

  Patient problems: Nerve Damage

  MAUDE report 10492123 ↗
• MalfunctionJul 10, 2020Energy Output Problem; No Apparent Adverse Event; Energy Output Problem; No Apparent Adverse Event

  DURING AN INDEPENDENT PROCEDURE WITH NO COMPANY REPRESENTATIVES PRESENT THE USER NOTED THE AIMING BEAM WAS SMALLER THAN USUAL BUT CONTINUED TO USE THE DEVICE. DURING CONTINUED USE OF THE DEVICE THE AIMING BEAM THEN APPEARED SCATTERED AT WHICH POINT THE DEVICE WAS REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10258802 ↗
• InjuryJun 30, 2020Adverse 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 PARALYSIS WAS CONFIRMED WHILE ABLATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV) BY PHRENIC NERVE PACING AND PALPATION. AT THE END OF THE PROCEDURE DIAPHGRAMATIC MOTION HAD IMPROVED ON FLUOROSCOPY. AT ONE WEEK FOLLOW-UP THE DIAPGRAMATIC MOTION APPEARED TO HAVE RECOVERED ON X-RAY BUT SOME DISCOMFORT WAS FELT DURING RESPIRATION.

  Patient problems: Nerve Damage

  MAUDE report 10215395 ↗
• InjuryJun 30, 2020Adverse 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 DIAPHRAGMATIC CAPTURE WAS NOTED WHEN PHRENIC NERVE PACING WAS STARTED BEFORE THE PHYSICIAN BEGAN ABLATING THE ANTERIOR WALL OF THE RIGHT INFERIOR PULMONARY VEIN (RIPV) AFTER ABLATING THE POSTERIOR WALL. LOSS OF DIAPHRAGMATIC CAPTURE WAS ALSO CONFIRMED BY PALPATION. DIAPHRAGMATIC PARALYSIS WAS PRESENT AT THE END OF THE PROCEDURE. ON (B)(6) 2020 IT WAS REPORTED THE PARALYSIS OF THE DIAPHRAGM WAS SLIGHTLY IMPROVED BUT THE PATIENT WAS STILL BEING MONITORED.

  Patient problems: Nerve Damage

  MAUDE report 10215134 ↗
• InjuryJun 9, 2020Adverse 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 DECREASE IN THE COMPOUND MOTOR ACTION POTENTIAL (CMAP) WAS NOTICED DURING TOUCH-UP ABLATION OF THE RIGHT SUPERIOR PULMONARY VEIN (RSPV) FOLLOWING THE INITIAL ABLATION OF ALL FOUR PVS. PHRENIC NERVE PACING WAS PERFORMED FROM MULTIPLE PACING SITES WITH NO RESPONSE. BECAUSE OF RESTRICTIONS DUE TO THE CORONAVIRUS ON HOSPITALS IN (B)(6), NO FURTHER INFORMATION COULD BE OBTAINED REGARDING THIS EVENT. FROM THE REPORTED INFORMATION, IT CANNOT BE DETERMINED IF A PHRENIC NERVE INJURY OCCURRED OR IF THE DECREASE IN CMAP AND LOSS OF PACING CAPTURE WAS TRANSIENT ONLY. THIS MDR IS BEING FILED BECAUSE IT CANNOT BE DEFINITIVELY DETERMINED THAT THERE WAS NO PHRENIC NERVE INJURY.

  Patient problems: Nerve Damage

  MAUDE report 10135800 ↗
• InjuryMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HOURS AFTER THE COMPLETION OF AN UNEVENTFUL PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION THE PATIENT EXHIBITED SYMPTOMS OF A CEREBRAL INFARCTION AND WAS TRANSFERRED TO A DIFFERENT HOSPITAL FOR TREATMENT. THE PATIENT WAS REPORTED TO HAVE RECOVERED AT THE TIME THE HOSPITAL NOTIFIED THE MANUFACTURER'S REPRESENTATIVE OF THIS EVENT. THE CAUSE OF THE CEREBRAL INFARCTION IS UNKNOWN AND IT CANNOT BE DETERMINED IF THERE IS ANY RELATIONSHIP WITH THE ABLATION SYSTEM. NO OTHER DETAILS ARE AVAILABLE FOR THIS EVENT.

  Patient problems: Infarction, Cerebral

  MAUDE report 10059047 ↗
• InjuryMay 7, 2020Adverse 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 REDUCTION IN DIAPHRAGMATIC MOTION WAS NOTICED VIA PALPATION DURING ABLATION OF THE RSPV. THE ABLATION WAS CONTINUED AND SUBSEQUENT DIAPHRAGMATIC PARALYSIS WAS CONFIRMED WITH NO RESPONSE TO PHRENIC NERVE PACING AND A REDUCED COMPOUND MOTOR ACTION POTENTIAL (CMAP) AMPLITUDE. WHEN PHRENIC NERVE PACING WAS PERFORMED AT THE END OF THE PROCEDURE, DIAPHRAGMATIC REACTION WAS OBSERVED BUT WAS REDUCED. DIAPHRAGMATIC PARALYSIS WAS STILL PRESENT AT DISCHARGE ALTHOUGH THE PATIENT WAS ASYMPTOMATIC.

  Patient problems: Nerve Damage

  MAUDE report 10035420 ↗
• InjuryMay 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PULMONARY VEIN ISOLATION PROCEDURE (PVI) TO TREAT ATRIAL FIBRILLATION WAS PERFORMED WITH ALL VEINS TREATED WITH THE HEARTLIGHT CATHETER. DURING TOUCH UP ABLATION WITH A RADIOFREQUENCY (RF) CATHETER AFTER ALL VEINS HAD BEEN TREATED, CARDIAC TAMPONADE WAS DIAGNOSED BY DECREASE IN BLOOD PRESSURE. THE DROP IN BLOOD PRESSURE WAS REPORTED TO HAVE STARTED APPROXIMATELY 10-15 MINUTES AFTER ABLATION WITH THE RF CATHETER BEGAN, ALTHOUGH THE EXACT TIME WAS NOT RECORDED. PERICARDIAL DRAINAGE WAS PERFORMED TO TREAT THE TAMPONADE. IN ADDITION TO THE RF CATHETER, A RING ELECTRODE CATHETER WAS USED PRIOR TO THE HEARTLIGHT CATHETER DURING THE PROCEDURE FOR FOUR OF THE PULMONARY VEIN TREATMENTS. BECAUSE OF RESTRICTIONS DUE TO THE CORONAVIRUS ON HOSPITALS IN (B)(6), NO FURTHER INFORMATION COULD BE OBTAINED REGARDING THIS EVENT. THIS MDR IS BEING FILED BECAUSE IT CANNOT DEFINITELY BE DETERMINED WHAT DEVICE OR DEVICES LEAD TO THE CARDIAC TAMPONADE.

  Patient problems: Cardiac Tamponade

  MAUDE report 10017544 ↗
• InjuryApr 29, 2020Adverse 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 DECREASE IN THE COMPOUND MOTOR ACTION POTENTIAL (CMAP) WAS NOTICED DURING ABLATION OF THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). THE ENERGY DELIVERY WAS STOPPED BUT THE DECREASED AMPLITUDE ON THE CMAP DID NOT RECOVER WHILE PHRENIC NERVE PASCING FROM THE RIGHT SUBCLAVIAN VEIN WAS STILL CAPTURED. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. BECAUSE OF RESTRICTIONS DUE TO THE CORONAVIRUS ON HOSPITALS IN (B)(6), NO FURTHER INFORMATION COULD BE OBTAINED REGARDING THIS EVENT. FROM THE REPORTED INFORMATION, IT CANNOT BE DETERMINED IF A PHRENIC NERVE INJURY OCCURRED OR IF THE DECREASE IN CMAP WAS TRANSIENT ONLY. THIS MDR IS BEING FILED BECAUSE IT CANNOT BE DEFINITIVELY DETERMINED THAT THERE WAS NO PHRENIC NERVE INJURY.

  Patient problems: Nerve Damage

  MAUDE report 10012106 ↗
• InjuryApr 16, 2020Adverse 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, THE PATIENT MOVED DURING ABLATION OF THE RIGHT INFERIOR PULMONARY VEIN (RIPV) CAUSING THE PHYSICIAN TO STOP ENERGY DELIVERY. AFTER ABLATION WAS RESUMED LOSS OF PHRENIC CAPTURE WAS NOTED ON THE COMPOUND MOTOR ACTION POTENTIAL (CMAP). PHRENIC PACING WAS PERFORMED SEVERAL TIMES BUT THERE WAS NO CAPTURE. ELEVATION OF THE DIAPHRAGM WAS VISUALLY CONFIRMED. THE ABLATION PROCEDURE WAS COMPLETED. THE PATIENT WAS DISCHARGED WITH THE PHRENIC NERVE PARALYSIS STILL PRESENT BUT WITHOUT ANY SYMPTOMS. NO PROLONGATION OF HOSPITALIZATION WAS REPORTED.

  Patient problems: Nerve Damage

  MAUDE report 9969524 ↗
• InjuryApr 8, 2020Adverse 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, REDUCTION IN DIAPHRAGMATIC MOTION WAS CONFIRMED BY PALPATION DURING ABLATION OF THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). THE PATIENT WAS DISCHARGED WITH THE PARALYSIS STILL PRESENT BUT WITHOUT ANY SYMPTOMS. NO PROLONGATION OF HOSPITALIZATION WAS REPORTED.

  Patient problems: Nerve Damage

  MAUDE report 9940765 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150026. One submission often covers many models, so check the product and lot details in each record.

• Z-1307-2025 · Feb 7, 2025 · Open, Classified
  CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of an Electrophysiology or Catheterization Labor