VersaCross Access SolutionRecalls & reported problems across all models

We found 19 models of VersaCross Access Solution by Baylis Médicale Cie Inc in the FDA's device registry (GUDID). Together they are named in 98 adverse event reports in the FDA's MAUDE database, received between Sep 27, 2022 and Jul 30, 2026 — classified as 3 deaths, 38 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (14 reports).

1 FDA recall record 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

VersaCross Access Solution 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. Jun 10, 2025Open, Classified

   Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.

   Z-2103-2025 · Root cause: Packaging change control · names 7 of these models · Recall details · FDA record ↗

Most reported VersaCross Access Solution problems

VersaCross Access Solution models

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

• VersaCross Access Solution VXSK0031

  Catheter, Septostomy
  1 recall16 reports
• VersaCross Access Solution VXSK0021

  Catheter, Septostomy
  1 recall1 death15 reports
• VersaCross Access Solution VXSK0032

  Catheter, Septostomy
  1 recall14 reports
• VersaCross Access Solution VXSK0022

  Catheter, Septostomy
  1 recall13 reports
• VersaCross Access Solution VXSK0024

  Catheter, Septostomy
  1 recall3 reports
• VersaCross Access Solution VXSK0025

  Catheter, Septostomy
  1 recall1 report
• VersaCross Access Solution VXSK0034

  Catheter, Septostomy
  1 recall1 report
• VersaCross Access Solution VXSK0021

  Catheter, Septostomy
  9 reports
• VersaCross Access Solution VXSK0022

  Catheter, Septostomy
  1 death6 reports
• VersaCross Access Solution VXSK0031

  Catheter, Septostomy
  5 reports
• VersaCross Access Solution VXSK0032

  Catheter, Septostomy
  3 reports
• VersaCross Access Solution VXSK0023

  Catheter, Septostomy
  1 death2 reports
• VersaCross Access Solution VXSK0033

  Catheter, Septostomy
  2 reports
• VersaCross Access Solution VXSK0003

  Catheter, Septostomy
  2 reports
• VersaCross Access Solution VXSK0033

  Catheter, Septostomy
  2 reports
• VersaCross Access Solution VXSK0011

  Catheter, Septostomy
  1 report
• VersaCross Access Solution VXSK0012

  Catheter, Septostomy
  1 report
• VersaCross Access Solution VXSK0024

  Catheter, Septostomy
  1 report
• VersaCross Access Solution VXSK0011

  Catheter, Septostomy
  1 report

Recent VersaCross Access Solution adverse event reports

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

• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient experienced Pericardial Effusion.During a Pulsed Field Ablation (PFA) procedure for the treatment of atrial fibrillation (AF), a VersaCross Access Solution was selected for use. Ultrasound guidance was used throughout the procedure. Prior to the event, the physician reported difficulty positioning a coronary sinus (CS) catheter due to challenging CS anatomy. Transseptal TSP) was successfully completed using a VersaCross RF Wire with a single application of RF energy. No resistance was reported during guidewire advancement, no multiple attempts were required to position the VersaCross Dilator on the septum, and no issues were reported with the RF wire during transseptal access. Immediately following completion of the TSP, intracardiac echocardiography (ICE) imaging revealed a pericardial effusion that appeared to be increasing in size. An echocardiography specialist subsequently assessed the finding and reported the effusion to be associated with the coronary sinus. At the time the effusion was identified, a non-Boston Scientific catheter was positioned across the septum. No ablation had been performed. The procedure was subsequently terminated. The pa

  Patient problems: Pericardial Effusion

  MAUDE report 50088147 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THROMBOSIS OCCURRED. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. THE TRANSEPTAL ACCESS WAS OBTAINED WITHOUT ISSUE AND THE PHYSICIAN LANDED VERSACROSS RF WIRE IN LEFT SUPERIOR PULMONARY VEIN (LSPV) AFTER CROSSING THE SEPTUM. VERSACROSS SHEATH WAS EXCHANGED FOR WATCHMAN TRUSTEER SHEATH AND THE RF WIRE WAS EXCHANGED FOR A NON-BOSTON SCIENTIFIC PIGTAIL CATHETER. THE PIGTAIL CATHETER AND WATCHMAN SHEATH WERE MOVED TO APPENDAGE OSTIUM. WHILE WAITING FOR THE ACT RESULT, ANESTHESIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGER POINTED OUT SMALL FLAPPING PIECE ATTACHED TO THE END OF LSPV WHICH WAS NOT NOTED BY ANYONE DURING PRE IMAGING DURING START OF THE CASE. IT WAS WATCHED FOR SEVERAL MINUTES AS ACT RESULTED 198. THE PHYSICIAN DECIDED IT WAS STABLE, MORE HEPARIN WAS GIVEN, AND PROCEDURE WAS COMPLETED AS USUAL. AFTER WATCHMAN DEVICE WAS EXPLANTED, SHEATH WAS PULLED BACK ACROSS SEPTUM AT WHICH TIME TEE IMAGER AND IMPLANTING PHYSICIAN NOTED OBJECT IN RIGHT ATRIUM ON THE FOSSA. THE PHYSICIAN DECIDED TO PUT WATCHMAN SHEATH UP TO OBJECT AND ASPIRATED IT. THE OBJECT WAS NO LONGER FOUND ON TEE, HOWEVER WHEN THE

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23598284 ↗
• InjuryJun 9, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION (PE) WAS NOTED. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. THERE WAS A TRACE EFFUSION NOTED BEFORE THE PROCEDURE STARTED AND IT WAS LOCATED AT THE APEX OF THE HEART. THE VERSACROSS WIRE WAS INSERTED IN THE SUPERIOR VENA CAVA (SVC), WITH THE SHEATH TO FOLLOW. THE PHYSICIAN BROUGHT THE WHOLE SYSTEM DOWN ONTO THE SEPTUM IN ORDER TO GET IN THE RIGHT POSITION TO CROSS AND GO INTO THE LEFT ATRIUM (LA). IN THE PROCESS OF TRYING TO GET THE CORRECT PLACEMENT ON THE SEPTUM THE ACCESS SYSTEM WAS PLACED IN THE RIGHT ATRIAL APPENDAGE AND THEN DROPPED ONTO THE SEPTUM. THE PHYSICIAN WENT TO CROSS THE SEPTUM AND HEAD INTO THE LEFT ATRIUM. ONCE ACROSS THE LEFT ATRIUM, THE RF WIRE WAS INSERTED INTO THE LEFT ATRIAL APPENDAGE AND THE VERSACROSS SYSTEM WAS TAKEN OUT, NEXT THE WATCHMAN DOUBLE CURVE SHEATH WAS INSERTED. ONCE THE DOUBLE CURVE WAS INSERTED THE NON-BOSTON SCIENTIFIC PIGTAIL CATHETER OVER THE RF WIRE AND THE WIRE WAS TAKEN OUT. LA PRESSURE WAS OBTAINED AT THIS POINT, AND A CONTRAST SHOT WAS TAKEN OF THE LEFT ATRIAL APPENDAGE TO DETERMINE WHAT SIZE WATCHMAN DEVICE. THE DEVICE WAS PREPPED, T

  Patient problems: Pericardial Effusion

  MAUDE report 22170061 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION (PE) WAS NOTED. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. THERE WAS A TRACE EFFUSION NOTED BEFORE THE PROCEDURE STARTED AND IT WAS LOCATED AT THE APEX OF THE HEART. THE VERSACROSS WIRE WAS INSERTED IN THE SUPERIOR VENA CAVA (SVC), WITH THE SHEATH TO FOLLOW. THE PHYSICIAN BROUGHT THE WHOLE SYSTEM DOWN ONTO THE SEPTUM IN ORDER TO GET IN THE RIGHT POSITION TO CROSS AND GO INTO THE LEFT ATRIUM (LA). IN THE PROCESS OF TRYING TO GET THE CORRECT PLACEMENT ON THE SEPTUM THE ACCESS SYSTEM WAS PLACED IN THE RIGHT ATRIAL APPENDAGE AND THEN DROPPED ONTO THE SEPTUM. THE PHYSICIAN WENT TO CROSS THE SEPTUM AND HEAD INTO THE LEFT ATRIUM. ONCE ACROSS THE LEFT ATRIUM, THE RF WIRE WAS INSERTED INTO THE LEFT ATRIAL APPENDAGE AND THE VERSACROSS SYSTEM WAS TAKEN OUT, NEXT THE WATCHMAN DOUBLE CURVE SHEATH WAS INSERTED. ONCE THE DOUBLE CURVE WAS INSERTED THE NON-BOSTON SCIENTIFIC PIGTAIL CATHETER OVER THE RF WIRE AND THE WIRE WAS TAKEN OUT. LA PRESSURE WAS OBTAINED AT THIS POINT, AND A CONTRAST SHOT WAS TAKEN OF THE LEFT ATRIAL APPENDAGE TO DETERMINE WHAT SIZE WATCHMAN DEVICE. THE DEVICE WAS PREPPED, T

  Patient problems: Pericardial Effusion

  MAUDE report 22170008 ↗
• InjuryJun 5, 2025Display or Visual Feedback Problem; Positioning Problem; Display or Visual Feedback Problem; Positioning Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION (PE) AND CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A PULMONARY VEIN ISOLATION PULSE FIELD ABLATION PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA. A PRE-PROCEDURE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) CONFIRMED THERE WAS NO CLOT IN THE APPENDAGE AND THERE WAS NO MENTION OF A BASELINE EFFUSION. THE PHYSICIAN OBTAINED GROIN ACCESS AND INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WAS PLACED. THE ATRIUM WAS EXTREMELY DILATED AND THE PHYSICIAN STRUGGLED TO GET THE TIP OF THE SHEATH ON FOSSA. THE DILATOR WAS WITHDRAWN OUT OF THE BODY, MORE CURVE WAS ADDED AND PLACED IT BACK INTO THE BODY THROUGH THE SHEATH THAT WAS IN THE BODY. WITH THE EXTRA CURVE PLACED ON THE DILATOR, THE PHYSICIAN WAS ABLE TO GET THE SHEATH TO REACH THE FOSSA. ONCE DROPPED ONTO THE FOSSA, THE RADIO FREQUENCY (RF) WAS APPLIED FOR TRANSSEPTAL PUNCTURE (TSP). THE TSP APPEARED TO VERY SUPERIOR AND THERE WAS NO CLEAR TENTING ON ICE. A BUBBLE STUDY WAS PERFORMED AND THERE WERE BUBBLES IN THE LEFT ATRIUM (LA) AND IT WAS CONFIRMED THE VERSACROSS SHEATH IN THE LA. AN ARTERIOGRAM CONTRAST SHOT WAS PERFORMED. AT

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 22149117 ↗
• InjuryJun 5, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION (PE) AND CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A PULMONARY VEIN ISOLATION PULSE FIELD ABLATION PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA. A PRE-PROCEDURE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) CONFIRMED THERE WAS NO CLOT IN THE APPENDAGE AND THERE WAS NO MENTION OF A BASELINE EFFUSION. THE PHYSICIAN OBTAINED GROIN ACCESS AND INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WAS PLACED. THE ATRIUM WAS EXTREMELY DILATED AND THE PHYSICIAN STRUGGLED TO GET THE TIP OF THE SHEATH ON FOSSA. THE DILATOR WAS WITHDRAWN OUT OF THE BODY, MORE CURVE WAS ADDED AND PLACED IT BACK INTO THE BODY THROUGH THE SHEATH THAT WAS IN THE BODY. WITH THE EXTRA CURVE PLACED ON THE DILATOR, THE PHYSICIAN WAS ABLE TO GET THE SHEATH TO REACH THE FOSSA. ONCE DROPPED ONTO THE FOSSA, THE RADIO FREQUENCY (RF) WAS APPLIED FOR TRANSSEPTAL PUNCTURE (TSP). THE TSP APPEARED TO VERY SUPERIOR AND THERE WAS NO CLEAR TENTING ON ICE. A BUBBLE STUDY WAS PERFORMED AND THERE WERE BUBBLES IN THE LEFT ATRIUM (LA) AND IT WAS CONFIRMED THE VERSACROSS SHEATH IN THE LA. AN ARTERIOGRAM CONTRAST SHOT WAS PERFORMED. AT

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 22149041 ↗
• MalfunctionMay 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT VERSACROSS ACCESS SOLUTION WAS SELECTED FOR PULSE FIELD ABLATION FARAPULSE PROCEDURE. DURING THE PROCEDURE, IT WAS MENTIONED THAT WHEN THE PHYSICIAN OPENED THE VERSACROSS ACCESS SOLUTION, THE RF WIRE WAS NOTED BROKEN INSIDE THE SEALED PACKAGE. AS THE DEVICE CAN NOT BE USED, IT WAS REPLACED WITH ANOTHER SAME MODEL KIT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070535 ↗
• MalfunctionMay 13, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. IT WAS MENTIONED THAT WHEN SHEATH AND WIRE INTO THE BODY AND WHEN ATTEMPT WAS MADE FOR TRANSSEPTAL, THE WIRE DID NOT CROSS. UNKNOWN TROUBLESHOOTING WERE MADE. FINALLY, THE WIRE WAS REPLACED AND WAS ABLE TO CROSS. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22012265 ↗
• MalfunctionApr 28, 2025Thermal Decomposition of Device; Device Displays Incorrect Message; Thermal Decomposition of Device; Device Displays Incorrect Message

  IT HAS BEEN REPORTED THAT A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. IT WAS MENTIONED THAT DURING THE PROCEDURE, THE TIP OF THE RF WIRE WAS NOTED CHAR (BLACK). KEEP SHOWING ERROR CODE METAL DETECTED. THUS, THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE REASON BEHIND THE EVENT IS UNKNOWN. THE PROBLEM ASSOCIATED WITH LABELED USE. THE EVENT OCCURRED INSIDE THE PATIENT BODY AND NO PATIENT COMPLICATION WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURN FOR ANALYSIS (DISPOSED). IT WAS MENTIONED THAT RF WAS DELIVERED 5 TIMES. ACT WAS OVER 300S. HEPARIN WAS ADMINISTERED BEFORE THE FEMORAL ACCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920181 ↗
• MalfunctionApr 28, 2025Thermal Decomposition of Device; Device Displays Incorrect Message; Thermal Decomposition of Device; Device Displays Incorrect Message

  IT HAS BEEN REPORTED THAT A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. IT WAS MENTIONED THAT DURING THE PROCEDURE, THE TIP OF THE VERSACROSS RF WIRE WAS NOTED CHAR (BLACK). KEEP SHOWING ERROR CODE METAL DETECTED. THUS, THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURN FOR ANALYSIS (DISPOSED). THE RF WAS DELIVERED 5 TIMES. ACT WAS OVER 300S. HEPARIN WAS ADMINISTERED BEFORE THE FEMORAL ACCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920176 ↗
• MalfunctionApr 22, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. AFTER THE SHEATH WAS ACROSS THE SEPTUM, THE PHYSICIAN NOTICED THAT BLOOD WAS DRIPPING OUT OF THE BACK OF THE HEMOSTATIC VALVE. THE PHYSICIAN OPTED TO CONTINUE THE PROCEDURE WITHOUT REPLACING THE SHEATH WITH SOME FLUID LEAKING FOR THE REST OF THE CASE. ABOUT 25CC OF BLOOD LOSS OCCURRED IN TOTAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882717 ↗
• MalfunctionMar 31, 2025Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN OR PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. IT WAS NOTED THAT THE VERSACROSS RF WIRE WOULD NOT ADVANCE OUT OF THE DISTAL TIP OF THE VERSACROSS DILATOR. A SECOND KIT WAS OPENED, AND SAME ISSUE WAS EXPERIENCED. BOTH WIRES WOULD NOT COME OUT OF THE TIP OF THE DILATOR. THUS, A THIRD KIT WAS OPENED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (RETAINED BY CUSTOMER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21732858 ↗
• MalfunctionMar 31, 2025Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN OR PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. IT WAS NOTED THAT THE VERSACROSS RF WIRE WOULD NOT ADVANCE OUT OF THE DISTAL TIP OF THE VERSACROSS DILATOR. A SECOND KIT WAS OPENED, AND SAME ISSUE WAS EXPERIENCED. BOTH WIRES WOULD NOT COME OUT OF THE TIP OF THE DILATOR. THUS, A THIRD KIT WAS OPENED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (RETAINED BY CUSTOMER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21732500 ↗
• MalfunctionMar 26, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A PULSE FIELD ABLATION PROCEDURE INDICATED FOR A PAROXYSMAL ATRIAL FIBRILLATION CASE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. WHEN THE PHYSICIAN ATTEMPTED TO PERFORM TRANSSEPTAL PUNCTURE, THE RADIO FREQUENCY (RF) WIRE WAS UNSUCCESSFUL CROSSING THE SEPTUM. THERE WERE SEVEN RF ATTEMPTS TAKEN INCLUDING REPOSITIONING THE DILATOR HOWEVER THE WIRE WOULD NOT CROSS. THUS, A VERSACROSS CONNECT KIT WAS OPENED AND TRANSSEPTAL WAS ACHIEVED IN FIRST ATTEMPT. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). NO OTHER ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21701081 ↗
• DeathMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT DEATH OCCURRED. THE PROCEDURE WAS CANCELLED. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE CTI LINE WAS PERFORMED IN THE RIGHT ATRIUM USING A NON-BOSTON SCIENTIFIC MAPPING CATHETER. AFTER THE CTI LINE WAS PERFORMED, THE PHYSICIAN PERFORMED TRANSEPTAL PUNCTURE WITH NO ISSUES REPORTED. ONCE ACROSS THE SEPTUM, THE VERSACROSS SHEATH WAS EXCHANGED FOR THE FARADRIVE SHEATH AND THE MAPPING CATHETER WAS INSERTED. IT WAS AT THIS POINT THAT THE PATIENT'S HEART RATE BECAME TACHYCARDIC AND HYPOTENSIVE WITH ONLY AN AVAILABLE READING OF MAP OF 24. THE BLOOD PRESSURE WAS THEN REATTEMPTED WITH A SYSTOLIC IN THE 60'S. THE PATIENT'S HEART RATE THEN DECLINED TO THE 50'S-40'S WHERE THEY WERE THEN PULSELESS ELECTRICAL ACTIVITY (PEA) AND REQUIRED RESUSCITATIVE EFFORTS. AN INTRACARDIAC ECHOCARDIOGRAPHY (ICE) SCAN DETECTED A PERICARDIAL EFFUSION WHICH LED TO CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED AND BLOOD WAS ADMINISTERED. THE PATIENT PASSED AWAY DESPITE THE EFFORTS OF THE LAB STAFF. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. THE PERICARDIAL EFFUSION WAS NOTED ON ICE IMAGE, BUT UNSURE OF EXACTLY

  Patient problems: Bradycardia; Cardiac Arrest; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion; Tachycardia

  MAUDE report 21699984 ↗

Other Baylis Médicale Cie Inc products

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