VersaCross™ Access Solution VXSK0122Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00685447019824), received between May 20, 2025 and Sep 22, 2026 — classified as 2 deaths, 10 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (4 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. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It has been reported that cardiac tamponade and perforation had occurred.During the pulmonary vein isolation procedure VersaCross Access Solution kit was selected for use. It has been mentioned that the access was obtained to right femoral vein and transeptal puncture was performed with access to the left atrium. About 20 seconds after transeptal puncture pressures began to rapidly decrease and cardiac perforation was noted. Pericardiocentesis was performed and patient was transferred to higher level of care for cardiac surgery. There was a tear in the left atrial appendage, and the appendage was surgically clipped. The patient was recovering in intensive care and now patient has been discharged from the hospital.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 50855196 ↗
• MalfunctionSep 16, 2026Failure to Advance

  It was reported that the septum could not be crossed.It was reported that during a pulse field ablation (PFA) procedure for the treatment of paroxysmal atrial fibrillation, a VersaCross Access Solution RF Wire was used to obtain transseptal access for pulmonary vein isolation (PVI). Following two unsuccessful attempts to cross the septum using RF energy ("buzz"), the physician increased the RF application duration, repositioned the wire, and confirmed optimal tenting of the septum. Despite three additional attempts, the wire was unable to cross the septum. The device was removed and replaced with another VersaCross device. The procedure was completed successfully using an alternate VersaCross Connect device. No patient complications were reported, and the patient remained stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788573 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Thrombosis occurred.It was reported that a VersaCross RF Wire was selected to treat atrial fibrillation (Afib). During procedure, patients activated clotting times (ACTs) were not therapeutic and a clot formed on right side of the heart. They were 244 then down to 233 and then up to 360 at discovery of thrombus on wire in right atrium (RA). There were no device issues reported. Product return is not expected as it was disposed.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50756610 ↗
• DeathAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced cardiac tamponade, pericardial effusion, and perforation of the left atrial appendage. The patient died.During a pulse field ablation (PFA) procedure to treat paroxysmal atrial fibrillation a VersaCross Access Solution radiofrequency (RF) wire was selected for use. A VersaCross fixed sheath was used with the RF wire to perform the transseptal puncture (TSP). It was noted that the RF wire went across the septum without delivery of RF energy. The physician spent some time checking intracardiac echocardiography (ICE) imaging before dilating the septum with the VersaCross fixed sheath. It was noted that the RF wire did not appear as it normally did going out the left superior pulmonary vein (LSPV) on fluoroscopy, though it did not appear entirely abnormal either. The VersaCross fixed sheath was exchanged for the FARADRIVE. With the FARAWAVE catheter inserted past the sheath handle and into the clear shaft, the sheath was aspirated. Only air was aspirated from the sheath; the air was observed being drawn back from the tip of the FARAWAVE catheter. The FARAWAVE catheter was removed, but air continued to be aspirated. The sheath was exchanged,

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50255873 ↗
• InjuryJul 27, 2026Off-Label Use

  It was reported that a patient experienced a pericardial effusion growing to a cardiac tamponade following a cardiac perforation requiring a pericardiocentesis, exploratory open-heart surgery, medication, and extended hospitalization. The ablation procedure was unable to be completed due to this adverse event.A VersaCross Access Solutions kit was selected for use for the transseptal access portion of a FARAPULSE procedure to treat atrial fibrillation. Femoral access was achieved and a non-Boston Scientific (BSC) sheath and the Radio Frequency (RF) Pigtail wire from a fixed curve VersaCross kit were advanced into the Superior Vena Cava (SVC) with the use of Intracardiac Echocardiography (ICE). At this time, ICE showed a trace amount of effusion in the pericardial space. The non-BSC sheath was dropped down onto the atrial septum for transeptal access. Access was gained on the mid septum with veins in view. The RF Pigtail wire was advanced into the left superior pulmonary vein (LSPV) and the non-BSC sheath was advanced into the left atrium. The non-BSC dilator and RF Pigtail wire were removed. The non-BSC sheath was aspirated and flush. A Merit guidewire and non-BSC mapping catheter w

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50000315 ↗
• MalfunctionJul 15, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING CARDIAC CATHERIZATION PROCEDURE A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE, PHYSICIAN OBTAINED FEMORAL VENOUS ACCESS USING A 4FR MICRO SHEATH. AN ATTEMPT WAS MADE TO EXCHANGE THE 4FR MICRO SHEATH FOR THE 8.5 VERSACROSS SHEATH. TRIED TO REMOVE THE WIRE BUT IT WAS STUCK IN THE VERSACROSS DILATOR. THUS, HAD TO REMOVE THE DILATOR AND OPEN A NEW VERSACROSS TO REPLACE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25829196 ↗
• MalfunctionMay 5, 2026Contamination; Material Integrity Problem

  IT WAS REPORTED THAT VERSACROSS ACCESS SOLUTION WAS SELECTED FOR AN ATRIAL FIBRILLATION ABLATION PROCEDURE. THE PHYSICIAN WAS REMOVING THE ABLATION CATHETER FROM THE VERSA CROSS SHEATH WHEN IT WAS NOTICED A CLEAR THREAD-LIKE PLASTIC HANGING OUT OF THE HUB. IT WAS PULLED AND A LONG PIECE OF IT CAME OUT. PROCEDURE AND DEVICE OUTCOME WERE UNKNOWN. NO PATIENT COMPLICATION WAS REPORTED. REPORT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082315 ↗
• MalfunctionMar 25, 2026Failure to Advance

  THE RF WIRE WAS SELECTED FOR USE DURING THE PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB). IT WAS REPORTED THAT WHEN ATTEMPTING TO GO TRANSEPTAL, THE WIRE WOULD NOT GO ACROSS AFTER RF ENERGY WAS DELIVERED. A NEW VERSACROSS WAS OPENED BUT ISSUE PERSISTED. REPLACING THE RF WIRE RESOLVED THE ISSUE. NO PATIENT COMPLICATIONS OCCURRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686141 ↗
• InjuryMar 11, 2026Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION (PE) OCCURRED. IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION PROCEDURE, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. THERE WAS A BASELINE SMALL EFFUSION SEEN ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE PATIENT HAD TO BE SUPPORTED FOR LOW BLOOD PRESSURE ALL THROUGHOUT THE CASE WHERE ANESTHESIA HAD TO KEEP INCREASING THE PRESSERS. AFTER ABLATING THE RIGHT INFERIOR PULMONARY VEIN (RIPV), THE PHYSICIAN CHECKED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) FOR PERICARDIAL EFFUSION AND SAW IT HAD GROWN SUBSTANTIALLY AS COMPARED TO BASELINE. 46 ABLATIONS HAD BEEN PERFORMED. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS ADMITTED TO INTENSIVE CARE UNIT AND EXPECTED TO FULLY RECOVER.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 24571717 ↗
• MalfunctionMar 9, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE COATING ON THE WIRE APPEARED TO BE PEELING OFF. THE VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE FOR TRANSSEPTAL. THE DEVICE DID NOT ENTER THE BODY WITH THE WIRE. THE WIRE WAS REPLACED, AND THE CASE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT RETURNING DUE TO DISPOSAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544035 ↗
• MalfunctionFeb 19, 2026Nonstandard Device

  IT WAS REPORTED THAT VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT THE PHYSICIAN WAS ATTEMPTING TO INTRODUCE THE DILATOR AND SHEATH COMBINATION INTO THE PATIENT'S BODY BUT WAS MET WITH FORCE. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE DISTAL END OF THE SHEATH HAD FOLDED/CURVED BACK OVER THE DILATOR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A NEW VERSACROSS SYSTEM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED. THE PRODUCT IS NOT EXPECTED TO BE RETURNING AS IT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390898 ↗
• MalfunctionFeb 13, 2026Nonstandard Device

  IT WAS REPORTED THAT VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. DURING THE PROCEDURE WHEN AN ATTEMPT WAS MADE FOR FEMORAL VEIN ACCESS FROM THE GROIN, THE DILATOR HAD RESISTANCE AND COULD NOT BE ADVANCED INTO THE VEIN. WHEN IT WAS WITHDRAWN, THE DISTAL END WAS FOUND TO BE ROLLED BACK AT THE END LIKE A SLEEVE. THE DILATOR WAS NOT FULLY INTRODUCED INTO THE VESSEL. THUS, THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURN AS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333558 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION OCCURRED. DURING A PULMONARY VEIN ISOLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION, AN VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. AFTER COMPLETING THE TRANSSEPTAL PUNCTURE, THE PHYSICIAN ADVANCED THE VERSACROSS WIRE INTO THE LEFT ATRIUM, RESULTING IN A PERFORATION OF THE LEFT ATRIAL APPENDAGE. THE PATIENT'S BLOOD PRESSURE AND PULSE DROPPED SIGNIFICANTLY, AND A PERICARDIAL EFFUSION WAS CONFIRMED USING ICE AND FLUOROSCOPY. A PERICARDIOCENTESIS WAS PERFORMED, AND THE PATIENT WAS STABILIZED. THE PATIENT WAS ADMITTED TO THE INTENSIVE UNIT OF CARE (ICU). THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR INVESTIGATION, AS IT WAS DISPOSED OF AT THE FACILITY.

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

  MAUDE report 24241550 ↗
• InjuryDec 23, 2025Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  THE VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE DURING THE PULSE FIELD ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB) AND ATRIAL FLUTTER. IT WAS REPORTED THAT DURING THE TRANSEPTAL PUNCTURE, THE AORTA WAS PUNCTURED AND THE VERSACROSS WIRE WAS VISUALIZED IN THE AORTA ON ICE. THE PHYSICIAN CONTINUALLY VIEWED ICE IMAGES AND DETERMINED THERE WAS A SMALL AREA OF BLEEDING BACK FROM THE AORTA TO THE RIGHT ATRIUM, BUT NO AORTIC HEMATOMA DEVELOPED. THE SHEATH AND DILATOR WERE NEVER ADVANCED AND THEREFORE ONLY THE WIRE WENT INTO THE AORTA. AT THIS POINT, THE PHYSICIAN HAD THE HEPARIN INFUSION STOPPED AND GAVE THE PATIENT PROTAMINE. THE RF APPLICATION THROUGH A NON-BSC DEVICE WAS DELIVERED AT 12:05 AND THE WIRE WAS PULLED OUT OF THE AORTA AT 12:20. THE PATIENT REMAINED STABLE AND WAS MONITORED FOR AN HOUR PRIOR TO ENDING THE PROCEDURE AND CLOSING THE GROIN ACCESS SITE. THE PATIENT WAS SET TO STAY OVERNIGHT AND WAS ORDERED A LIMITED ECHOGRAM. THE PATIENT REMAINED STABLE THROUGHOUT THE MONITORING PERIOD AND THE PHYSICIAN PLANS TO BRING THE PATIENT BACK AT A LATER DATE TO COMPLETE THE ABLATION PROCEDURE. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Needle Stick/Puncture; Perforation of Vessels

  MAUDE report 23879424 ↗
• InjuryDec 19, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED THAT A CARDIAC PERFORATION AND PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A CONCOMITANT ATRIAL FIBRILLATION ABLATION AND WATCHMAN PROCEDURE, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. THERE WAS A TRACE EFFUSION PRIOR TO THE PROCEDURE. THE ATRIAL FIBRILLATION ABLATION PERFORMED WITH A NON-BOSTON SCIENTIFIC (AFFERA) SYSTEM. THE ABLATION WAS COMPLETED WITHOUT COMPLICATION. AFTERWARD, THE PHYSICIAN ELECTED TO PERFORM A SHEATH EXCHANGE AND INITIALLY PLACED A SHORT 16F INTRODUCER SHEATH. DURING THIS PROCESS, THE WIRE WAS INADVERTENTLY WITHDRAWN FROM THE LEFT ATRIUM, RESULTING IN LOSS OF TRANSSEPTAL ACCESS. THE PHYSICIAN RE-CROSSED THE SEPTUM USING THE VERSACROSS FIXED-CURVE SYSTEM UNDER 2D INTRACARDIAC ECHOCARDIOGRAPHY (ICE) GUIDANCE. AS THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PHYSICIAN HAD NOT YET ARRIVED, THE SHEATH EXCHANGE PROCEEDED USING ICE ALONE. THE WIRE APPEARED APPROPRIATELY POSITIONED IN THE LEFT SUPERIOR PULMONARY VEIN DURING THE EXCHANGE ACCORDING TO THE ICE VIEW, AFTER WHICH THE WIRE WAS REMOVED AND A NON-BOSTON SCIENTIFIC PIGTAIL CATHETER WAS INSERTED. AT NO POINT DID THE WATCHMAN DOUBLE-CURVE SHEATH ENTER THE LEFT ATRI

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

  MAUDE report 23854561 ↗
• MalfunctionDec 15, 2025Nonstandard Device; Physical Resistance/Sticking; Nonstandard Device; Physical Resistance/Sticking

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. THE VERSACROSS ACCESS SOLUTION WAS ADVANCED INTO THE SUPERIOR VENA CAVA AND THE SHEATH/DILATOR WAS LOADED ONTO THE WIRE. THE PHYSICIAN WAS ABLE TO ADVANCE THE DILATOR INTO THE FEMORAL ACCESS SITE BUT GOT STUCK AT THE SHEATH/DILATOR TRANSITION AND COULD NOT ADVANCE FURTHER. THE SHEATH WAS REMOVED FROM THE WIRE AND IT WAS OBSERVED THAT THE TIP OF THE SHEATH WAS STRETCHED AND BUCKLING BACKWARDS FROM THE DILATOR. A NEW VERSACROSS KIT WAS OPENED AND THE NEW SHEATH WAS ABLE TO ADVANCE THROUGH THE ACCESS SITE EASILY. THE DEVICE WILL NOT BE AVAILABLE FOR RETURN DUE TO DISPOSAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804064 ↗
• MalfunctionDec 11, 2025Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT THE RF WIRE COATING WAS FRAYED ON THE PROXIMAL END AND A SHEATH COULD NOT BE LOADED ONTO IT. DURING A PULSE FIELD ABLATION (PFA) PULMONARY VEIN ISOLATION (PVI) AND POSTERIOR WALL (PW) ABLATION PROCEDURE TO TREAT PERSISTENT ATRIAL FIBRILLATION A VERSACROSS RF WIRE WAS USED. THE RF WIRE WAS PREPARED AND A VERSACROSS FIXED SHEATH WAS ADVANCED INTO THE BODY OVER THE WIRE. THE TRANSSEPTAL PUNCTURE WAS PERFORMED SUCCESSFULLY. THE VERSACROSS SHEATH WAS BACKED OUT OF THE PATIENT OVER THE RF WIRE, AND AN ATTEMPT WAS MADE TO LOAD THE FARADRIVE SHEATH OVER THE WIRE, BUT THE FARADRIVE DILATOR WOULD NOT ENGAGE WITH THE WIRE. AFTER A SECOND ATTEMPT TO LOAD THE FARADRIVE SHEATH ONTO THE RF WIRE IT WAS NOTICED THAT THE PROXIMAL END APPEARED FRAYED, AND THAT A PIECE OF THE FRAYED COATING COULD BECOME DISLODGED AND EMBOLIZE IF ATTEMPTS IF A SHEATH WERE FORCED OVER IT. STERILE CLAMPS WERE USED ATTEMPTING TO REMOVE THE FRAYED COATING, BUT THIS WAS UNSUCCESSFUL AND ONLY FURTHER MANGLED THE COATING. RATHER THAN REMOVING THE RF WIRE AND LOSING TRANSSEPTAL ACCESS, A DECISION WAS MADE TO USE NON-STERILE WIRE CUTTERS TO CLIP THE FRAYED END OF THE WIRE OFF ENTIRELY. THE PROXIMAL END OF T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777690 ↗
• InjuryOct 28, 2025Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT ST SEGMENT ELEVATION OCCURRED. DURING AN ATRIAL FIBRILLATION/ATRIAL FLUTTER PROCEDURE, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. THE PHYSICIAN PERFORMED TRANSSEPTAL PUNCTURE, FARADRIVE SHEATH EXCHANGE TO ADVANCE OVER LEFT ATRIUM WAS DIFFICULT BECAUSE THE VERSACROSS WIRE INSULATION FROM PROXIMAL END WAS FRAYED. FARAPULSE PULSE FIELD ABLATION WAS APPLIED USING FARAWAVE NAV TO COMPLETE PULMONARY VEIN ISOLATION AND POSTERIOR WALL ISOLATION. AN ATRIAL TACHYCARDIA WAS ABLATED WITH THE FARAWAVE ANTERIOR AND INFERIOR TO THE LEFT INFERIOR PULMONARY VEIN (LIPV), NEAR THE MITRAL VALVE ISTHMUS AND LIKELY ADJACENT TO THE CIRCUMFLEX CORONARY ARTERY. PATIENT'S ECG DID NOT HAVE NOTICEABLE ST SEGMENT CHANGES AFTER ABLATION DELIVERY. PATIENT WAS ATRIAL-PACED TO INDUCE ATRIAL TACHYCARDIA. ISOPREL WAS INFUSED AND PATIENT WAS CONTINUALLY PACED. ISOPREL INFUSION WAS INCREASED, PATIENT WAS PACED, AND PHYSICIAN NOTICED ST SEGMENT ELEVATION. ISUPREL AND PACING WERE TERMINATED AND A 100MCG NITROGLYCERINE WAS ADMINISTERED THROUGH THE FARADRIVE SHEATH AND A SUBSEQUENT 100MCG WERE ADMINISTERED VIA IV. ST SEGMENT ELEVATION RESOLVED AFTER THE SECOND DOSE OF NITROGLYCERINE. THE PATIE

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23408354 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS PERICARDIAL EFFUSION OCCURRED. THE PROCEDURE WAS ABORTED. IT WAS REPORTED THAT VERSACROSS ACCESS SOLUTION WAS SELECTED FOR LAAC PROCEDURE. DURING THE PROCEDURE, THE PATIENT WAS PLACED UNDER ANESTHESIA, AND THE PROCEDURE WAS BEGUN. THE PHYSICIAN WAS GOT AN ACCESS AND ASKED FOR 5,000 UNITS OF HEPARIN. TRANSEPTAL POSITION WAS VIEWED IN SHORT AXIS AND BICAVAL VIEWS AND TRANSEPTAL WAS PERFORMED IN A MID/ INFERIOR POSITION USING THE VERSACROSS TRANSEPTAL SHEATH AND WIRE. POST TRANSEPTAL, THE PATIENTS EXPERIENCED A DROP IN BLOOD PRESSURE WITH PERICARDIAL EFFUSION NOTED BY CARDIAC IMAGER. PATIENT WAS MONITORED BY ANESTHESIA, THE PHYSICIAN AND CARDIAC IMAGER. HEPARIN WAS REVERSED WITH PROTAMINE FOR THAT PHYSICIAN DECIDED AGAINST DOING A PERICARDIOCENTESIS. THE PROCEDURE WAS ABORTED AND PATIENT DID NOT RECEIVE THE WATCHMAN IMPLANT. THE PATIENT IS EXPECTED TO FULLY BE RECOVERED AS PATIENT STAYED OVERNIGHT AS PLANNED TO DISCHARGE ON (B)(6) 2025. THERE WAS A MINOR PERICARDIAL EFFUSION NOTED PRIOR, NOTED UNDER THE RIGHT VENTRICLE ON TEE. THE EFFUSION INCREASED IN SIZE AFTER TRANSEPTAL PUNCTURE. THE DEVICE IS NOT EXPECTED TO RETURN AS DISCARDED. IT WAS FURTHER REPORTED THAT THE VERSACROSS

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 23294735 ↗
• DeathJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT DEATH OCCURRED. DURING A PULMONARY VEIN ISOLATION ABLATION PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE PHYSICIAN OBTAINED ACCESS IN BOTH RIGHT AND LEFT FEMORAL VEIN. INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGINING WAS INSERTED IN LEFT FEMORAL VEIN. THE GUIDEWIRE WAS ADVANCED TO SUPERIOR VENA CAVA (SVC) AND THEN THE VERSACROSS TRANSSEPTAL SHEATH AS WELL AS THE RF WIRE. THE TRANSSEPTAL PUNCTURE (TSP) AND THE RF WIRE WERE ADVANCED IN THE LEFT ATRIUM. THERE WAS NO DIFFICULTY NOTED WITH THE TSP WORKFLOW. THE PATIENT HAD AN INCREASED HEART RATE OF 215 BPM THAT SUSTAINED FOR A MINUTE. THEN PERICARDIAL EFFUSION (PE) WAS NOTED ON ICE IMAGING AND A PERICARDIOCENTESIS BEGAN. CARDIOPULMONARY RESUSCITATION (CPR) WAS STARTED AND CODE BLUE ALARM WAS CALLED. THE PATIENT WAS ASYSTOLE. THE PHYSICIAN OPENED PATIENT CHEST, AND BLOOD TRANSFUSION BEGAN. CARDIAC MESSAGE WAS PERFORMED. SODIUM BICARB WAS GIVEN THROUGH THE SHEATH. VASOPRESSORS GIVEN BY IC PHYSICIAN. AORTIC CANNULATION WAS ADMINISTERED AND VENOUS PERFUSION BEGAN. THE BYPASS SURGERY WAS INITIATED. A 90 VOLT SHOCK ADMINISTERED TO HEART, HOWEVER LATER THE PATIENT WAS DECLARED DEAD. THE AUTOPSY H

  Patient problems: Asystole; Cardiac Arrest; Cardiac Perforation; Pericardial Effusion; Tachycardia

  MAUDE report 22123765 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE PHYSICIAN USING SOLO OPERATOR TECHNIQUE USING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE STAFF WAS STILL NOT PREPARED TO INITIATE THE ENERGY FOR TRANSSEPTAL PUNCTURE AS THEY STILL HAD TO APPLY GROUNDING PAD. THE PHYSICIAN LOST VISUALIZATION OF THE INTRA ATRIAL SEPTUM, THEN GOT POOR QUALITY IMAGES AND USED ENERGY. THE WIRE DID NOT LOOK NORMAL THUS, IT WAS REMOVED. IT WAS NOTED THE ARTERIAL LINE PRESSURES DECREASED AND EFFUSION WAS PRESENT IN THE LEFT VENTRICULAR (THE INOCULATED BEHIND LEFT ATRIUM). THE PATIENT WAS TAPPED FOR TAMPONADE AND 400 ML TAKEN OFF AND NO MORE ACCUMULATION. THE PATIENT WAS FULLY RECOVERED AND WAS DISCHARGED NEXT DAY FROM THE HOSPITAL (B)(6) 2025). THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

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

  MAUDE report 22052961 ↗