VersaCross Connect Access Solution for FARADRIVE VXAK0041Recalls & reported problems

Summary

The FDA's MAUDE database contains 275 adverse event reports that list this exact device (DI 00685447019046), received between May 24, 2024 and Sep 22, 2026 — classified as 3 deaths, 114 injuries, 158 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (51 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 275 reports, in the reporter's own words as published by the FDA.

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

  It was reported that an allergic reaction occurred.A pulse field ablation procedure with transseptal puncture was performed using FARADRIVE sheath, FARAWAVE catheter and VersaCross Connect Radio Frequency (RF) wire. Immediately post procedure, patient became hypotensive, tachycardic and hypoxic. Protamine was reversed, saline was administered and a Transesophageal Echocardiogram (TEE) was performed. No pericardial effusion was observed, and patient began recovering and was admitted to the Intensive Care unit (ICU) for monitoring. The physician suspected that an allergic reaction to protamine had occurred. The patient was discharged from the hospital one day post index procedure.

  Patient problems: Hypersensitivity/Allergic reaction; Hypoxia; Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 50856296 ↗
• InjurySep 22, 2026Difficult to Advance

  It was reported that the radiofrequency (RF) wire had difficulty to crossing the septum and advancing into the left atrium (LA) and the patient experienced cardiac tamponade, pericardial effusion, and hypotension.During an ablation procedure to treat paroxysmal atrial fibrillation a VersaCross Connect Access Solution for FARADRIVE RF Wire was used. A cavotricuspid isthmus ablation was performed with a non-Boston Scientific RF catheter prior to attempting the transseptal puncture (TSP). The VersaCross Connect for FARADRIVE system was positioned in optimal TSP position using fluoroscopy and intracardiac echocardiography (ICE). The RF Wire crossed the septum, but the tip got caught either on the septum or the LA free wall during the one second RF cautery period. There was some difficulty advancing the wire and the physician stated this did not feel normal. The FARADRIVE sheath was advanced into the LA, and the VersaCross Connect RF Wire and dilator were removed from the patient. Preparations were made to insert a non-Boston Scientific mapping catheter into the sheath, but it was found that the sheath had lost transseptal access. Another TSP was to be attempted with the RF Wire and dil

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

  MAUDE report 50852630 ↗
• MalfunctionSep 21, 2026Material Frayed

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848673 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50829552 ↗
• MalfunctionSep 18, 2026Deformation Due to Compressive Stress; Material Integrity Problem

  It was reported that Guidewire Coating Issue occurred.It was reported that a VersaCross Mechanical Guidewire was selected for pulmonary vein isolation (PVI), pulmonary wall isolation (PWI), cavotricuspid isthmus (CTI) and mitral isthmus (MI) to treat atrial fibrillation (Afib). Prior to procedure, upon opening package, the guidewire was bent or kinked and frayed. Guidewire was replaced and procedure was completed without patient complications. Product return is not expected as it was disposed. It was further informed that the damage was observed in the mechanical guidewire and the coating was scraped. The fraying occurred in the proximal end of the guidewire. Additionally, there were no patient complication's reported, it was a good patient outcome.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819154 ↗
• InjurySep 15, 2026Difficult to Advance

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

  MAUDE report 50779973 ↗
• MalfunctionSep 8, 2026Material Perforation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676104 ↗
• DeathSep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Death, Cardiac Arrest, Ventricular Fibrillation, Ventricular Tachycardia, Hypotension and Bradycardia occurred.A concomitant procedure (ablation/left atrial appendage closure (LAAC)) was being performed. A WATCHMAN TruSteer Access System (WAS), a 31mm WATCHMAN FLX Pro LAA Closure Device and Delivery System (WDS), a FARAWAVE catheter and a VersaCross Connect Access Solution for FARADRIVE were selected for use. After the ablation portion of the procedure, the LAAC procedure was completed without any reported complications. Electrocardiogram (EKG) monitoring showed no ST-segment elevation or evidence of any lethal arrhythmias. At the conclusion of the procedure, the physician was in the process of closing the groin access site, and protamine was administered to reverse the effects of heparin anticoagulation. The anesthesia physician observed a sudden decline in the patient's blood pressure along with bradycardia. Cardiopulmonary resuscitation (CPR) was initiated. A transesophageal echocardiogram (TEE) was performed to evaluate for a potential pericardial effusion or cardiac tamponade as a cause of the hemodynamic instability. No pericardial effusion was identified

  Patient problems: Bradycardia; Cardiac Arrest; Low Blood Pressure/ Hypotension; Tachycardia; Ventricular Fibrillation

  MAUDE report 50670664 ↗
• MalfunctionSep 4, 2026Failure to Advance; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50620080 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It has been reported that bradycardia, pericardial effusion and cardiac tamponade occurred post procedure 3hrs later. VersaCross Connect Access Solution for Faradrive kit was selected for use and during a transesophageal echocardiogram (TTE), a pericardial effusion was noted. Patient was brought back into the room to get a Pericardiocentesis. Pigtail versacross was used in the procedure. The patient has been discharged. The VersaCross wire is not available for return as it was discarded at the end of the case.

  Patient problems: Bradycardia; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50546349 ↗
• MalfunctionAug 24, 2026Difficult to Advance; Physical Resistance/Sticking

  It was reported that during Post Procedure/Prior to Discharge for a Pulse Field Ablation (PFA) procedure a VersaCross Connect Access Solution for Faradrive RF wire was selected for use. Posterior to transseptal procedure using Versacross connect, the wire could not be removed from the dilator. The procedure was completed with original device. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50399362 ↗
• MalfunctionAug 21, 2026Material Frayed; Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50372481 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient experienced vision blurred and numbness in the left arm. During a Pulse Field Ablation Procedure (PFA) to treat atrial fibrillation a FARAWAVE Cathether and a VersaCross Connect Access Solution for FARADRIVE were selected for use. No issues with the transseptal puncture was reported. Right Inferior Pulmonary Vein (RIPV) was extremely small, while in basket, 301 errors were received, catheter was repositioned and still received errors and ultimately the catheter formed a cobra shape. It was removed the catheter and manually separated the splines, went back into the Left Atrium (LA) and tried to reattempt basket in the RIPV, catheter went cobra again. There was difficulty delivering the basket into the RIPV. Bubbles appeared while delivering in basket configuration due to something that typically occurs which is caused by an inadequate tissue contact because the basket is undersized. If the electrodes are too close, the system has a built-in safety mechanism that automatically discontinues energy delivery. Physician indicated that there may have been excessive therapy delivery in the RIPV region. Physician believes that 301 errors and additional applica

  Patient problems: Blurred Vision; Numbness

  MAUDE report 50228399 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced hemorrhage, pseudoaneurysm. A pulmonary vein isolation (PVI) procedure was performed as planned, with no complications reported. Following completion of the procedure and closure of the access site, the patient was observed to have greater-than-expected bleeding from the incision site. In response, manual pressure was applied and a device was placed to control the bleeding. Subsequently, during post-procedural monitoring, the patient developed a pseudoaneurysm at the access site. The following day, the patient was admitted to the hospital for further evaluation and monitoring.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pseudoaneurysm

  MAUDE report 50223119 ↗
• InjuryAug 3, 2026Device-Device Incompatibility; Difficult to Advance

  During procedure for a Pulse Field Ablation (PFA) and a Watchman Left Atrial Appendage Closure (LAAC) FLX Pro procedure to treat Atrial Fibrillation a VersaCross Connect Access Solution for FARADRIVE and a Farawave Ablation Catheter were selected for use. Procedure started at 13:00, with a patient cleared for pericardial effusion at the beginning of case by the physician. Physician experienced difficulty getting the VersaCross into the Superior Vena Cava (SVC) due to pacer leads, wire was exchange for J-tipped (Non-BSC) wire to navigate through leads, once inside SVC wire was exchanged again. Upon dropping down onto the fossa to perform transeptal puncture, with no felt resistance or difficulty, it was noted the septum was thickened, which lead to an unsuccessful first attempt to cross, second attempt was successful. Then, patient had ablation performed with no symptoms and/or decompensation. Watchman sheath was inserted at 13:58, pigtail was placed into LAA and angio was performed. Drawing was marked on fluoroscopy and selected 31mm, it was prepared and inserted through Trusteer sheath. With the use of TEE Watchman was deployed and ran through PASS criteria. Implant was successful

  Patient problems: Pericardial Effusion

  MAUDE report 50112281 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a FARAWAVE Nav Catheter and VersaCross Connect Access Solution for FARADRIVE were selected for use during a repeat Pulse Field Ablation (PFA) procedure. Following the procedure on (b)(6) 2026, ward staff noted hypotension with systolic blood pressure of approximately 90 mmHg. The suspected cause was medication. The patient denied dizziness and was reported to be asymptomatic. Perindopril was withheld for one week, and the hypotension resolved on (b)(6) 2026. On (b)(6) 2026, red-colored urine was observed. Hematuria was identified by dipstick urinalysis and subsequently confirmed by microscopic specimen collection (MSC). Urinalysis also confirmed hemoglobinuria. The patient received 500 mL of 0.9% sodium chloride intravenously. The urine color returned to normal later the same day. As part of the post-ablation protocol, laboratory testing was performed. On (b)(6) 2026, pre-discharge laboratory results confirmed hemolysis. Repeat full blood count (FBC), creatinine, and haptoglobin testing were conducted approximately 24 hours post-ablation. A nursing night shift progress notes dated (b)(6) 2026, documented, "good amounts of urine as per FBC (fluid balance chart)

  Patient problems: Hematuria; Hemolysis; Pericardial Effusion

  MAUDE report 50057162 ↗
• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPOTENSION, A NON-CONTRACTILE RIGHT VENTRICLE (RV), CARDIAC TAMPONADE, AND PERICARDIAL EFFUSION. DURING A PULSE FIELD ABLATION (PFA) PROCEDURE TO TREAT PAROXYSMAL ATRIAL FIBRILLATION A VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE RF WIRE WAS USED. THE TRANSSEPTAL PUNCTURE (TSP) WAS PERFORMED, AND THE ABLATION PROCEDURE WAS PROCEEDING NORMALLY, BUT DURING ABLATION OF THE POSTERIOR WALL ERROR 301 PRE-PULSE FAILURE OCCURRED EIGHT TIMES ON THE GENERATOR. PULMONARY VEIN ISOLATION HAD BEEN COMPLETED BY THE TIME OF THE ERROR. IT WAS NOTED THAT THE CATHETER SPLINES WERE SEPARATED DURING THE ABLATION ATTEMPTS. THE PROCEDURE WAS SUSPENDED DUE TO THE GENERATOR ERROR, AND THE FARAWAVE CATHETER WAS REMOVED. AFTER THE PATIENT WAS CARDIOVERTED, HYPOTENSION PRESENTED AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) SHOWED A NON-CONTRACTILE RV AND PERICARDIAL EFFUSION LOCATED ON THE POSTERIOR PART OF THE LEFT ATRIUM (LA). THE NON-CONTRACTILE RV WAS REVERSED WITH VASOACTIVE MEDICATIONS. PERICARDIAL DRAINAGE WAS PERFORMED FOLLOWED BY EMERGENCY SURGERY WITH CARDIOPULMONARY BYPASS (CPB). THE PATIENT WAS HOSPITALIZED AN

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

  MAUDE report 25825818 ↗
• InjuryJul 13, 2026Positioning Failure; Difficult to Advance

  IT WAS REPORTED THAT A PATIENT EXPERIENCED CARDIAC TAMPONADE AND HYPOTENSION. THE PROCEDURE WAS CANCELLED. A FARADRIVE SHEATH AND A VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE WERE SELECTED TO PERFORM A PULSE FIELD ABLATION FOR THE ISOLATION OF PULMONARY VEINS TO TREAT ATRIAL FIBRILATION. A CARDIAC TAMPONADE OCCURRED DURING TRANSEPTAL ACCESS. THE PHYSICIAN HAD ACCESS WITH THE PATIENT HEPARINIZED TO A TARGET OF 350 ACT. A NON-BOSTON SCIENTIFIC CATHETER WAS SITTING IN THE RIGHT VENTRICLE DURING TRANSEPTAL. ICE WAS INTRODUCED INTO THE RIGHT ATRIUM FIRST AND BASE LINE CARDIAC CHARACTERISTICS WERE ASSESSED WITH NO FLUID APPARENT AT BASELINE IN THE PERICARDIAL SPACE. ACCESS WAS OBTAINED WITH A 10F SHEATH WHICH WAS THEN UPSIZED TO THE FARADRIVE OVER THE VERSACROSS WIRE. THE PIGTAIL OF THE VERSACROSS WIRE WAS SITTING UP IN THE SUPERIOR VENA CAVA (SVC). THE FARADRIVE DRIVE SHEATH WAS ADVANCED UP TO THE SUPERIOR VENA CAVA (SVC). THE PHYSICIAN PROCEEDED TO PERFORM A DROP DOWN ONTO THE FOSSA OVALIS UNDER FLOUROSCOPIC AND ICE GUIDANCE. TENTING ON THE FOSSA OVALIS WAS CONFIRMED AND THE PHYSICIAN CROSSED INTO THE LEFT ATRIUM (LA) WITH THE VERSACROSS WIRE CONFIRMED UNDER ICE. THE PATIENT HAD

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

  MAUDE report 25796582 ↗
• MalfunctionJul 1, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING THE ATRIAL FIBRILLATION PROCEDURE VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE KIT WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT BOX WAS BROKEN (SHEATH PACKAGING DAMAGED). SECOND SHEATH WIRE PRODUCED ERROR CODE ON BAYLIS SO NEW KIT NEEDED TO BE OPENED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED. THE PRODUCT IS NOT EXPECTED TO BE RETURNED AS IT HAS BEEN CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25678089 ↗
• InjuryJun 26, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A PATIENT EXPERIENCED HYPOTENSION AND BILATERAL LOBE PNEUMONIA . DURING PROCEDURE FOR A PULSED FIELD ABLATION (PFA) PROCEDURE TO TREAT PAROXIMAL AF AN RF WIRE WAS SELECTED FOR USE, IT WAS NOTED THAT DURING ACCESS WIRE GOT KINKED WITH ROUTINE USE. THE WIRE WAS REPLACED AND THE PFA THERAPY PROCEDURE WAS COMPLETED. POSTERIOR TO THERAPY CULMINATION, PATIENT EXPERIENCED HYPOTENSION. INTRACARDIAC ECHOCARDIOGRAPHY WAS PERFORMED TO OBSERVED VENTRICLES; EFFUSION WAS RULED OUT. PAN SCAN CT WAS PERFORMED, DEMONSTRATING BILATERAL LOBE PNEUMONIA. THE PATIENT REQUIRED HOSPITALIZATION, ADMITTED TO INTENSIVE CARE UNIT (ICU), RECOVERED AND DISCHARGED. THE PATIENT IS EXPECTED TO FULLY RECOVER FROM THE EVENT. THE DEVICE IS NOT EXPECTED TO RETURN AS IT WAS DISPOSED.

  Patient problems: Low Blood Pressure/ Hypotension; Pneumonia

  MAUDE report 25632667 ↗
• MalfunctionJun 19, 2026Deformation Due to Compressive Stress; Material Integrity Problem

  IT WAS REPORTED THAT VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE WAS SELECTED FOR PULMONARY VEIN ISOLATION PROCEDURE. DURING THE INSERTION, PHYSICIAN INTRODUCED THE FARADRIVE ON THE WIRE, IT WAS ENCOUNTERED A PART OF THE WIRE GOT KINKED AND COATING MADE UNABLE TO PASS FARADRIVE THROUGH. THE INSULATION WAS DAMAGED AND DETACHED. THE WIRE INSULATION STRIP OFF AT PROXIMAL END. THE PHYSICIAN DID FEEL LIKE THE WIRE WAS GETTING CAUGHT WHILE RETRACTING, REQUIRING THEM TO PULL WITH EXCESSIVE FORCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING DIFFERENT DEVICE, SAME MODEL. NO PATIENT COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566231 ↗
• MalfunctionJun 15, 2026Positioning Failure; Difficult to Advance

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION PROCEDURE, A VERSACROSS CONNECT WAS SELECTED FOR USE. DURING PROCEDURE, THE DEVICE COULD NOT GET REACH ON THE TRANSEPTAL. OPENED THE VERSACROSS FIXED SHEATH AND ISSUE WAS RESOLVED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25513191 ↗
• MalfunctionMay 29, 2026Material Integrity Problem

  IT WAS REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE SELECTED FOR AN ATRIAL FIBRILLATION PULMONARY VEIN ISOLATION (PVI) PROCEDURE. DURING PROCEDURE, WHEN THE PHYSICIAN TRIED TO INSERT THE RF WIRE INTO VERSACROSS DILATOR, THE INSULATION PEELED BACK. BEFORE INSERTION NO DAMAGE WAS OBSERVED ON THE DEVICE. THUS THE WIRE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334475 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED FOLLOWING THE OCCURRENCE OF A VASCULAR PERFORATION. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE WAS SELECTED FOR USE. WHILE ADVANCING THE SYSTEM, THE DILATOR PULLED BACK UNEXPECTEDLY, RESULTING IN DISPLACEMENT OF THE WIRE AND SUBSEQUENT PERFORATION. THE PHYSICIAN REPORTED THAT THE DEVICE AND/OR PROCEDURAL INTERACTION CONTRIBUTED TO THE EVENT, NOTING THAT THE DILATOR WAS LOOSE AT THE TIME. A BALLOON WAS PLACED IN THE LEFT ILIAC VEIN AS PART OF THE INTERVENTION. THE PROCEDURE WAS UNSUCCESSFUL DUE TO THE PERFORATION. THE PATIENT WAS NOT ADMITTED BEYOND THE STANDARD OF CARE AND IS EXPECTED TO FULLY RECOVER. FURTHER INFORMATION WAS RECEIVED INDICATING THAT THE DILATOR WAS LOOSE, MEANING THE DILATOR WAS NOT PROPERLY SNAPPED INTO OR SECURED WITH THE SHEATH, RESULTING IN INADEQUATE FIXATION BETWEEN COMPONENTS. THE RF WIRE WAS EXPOSED OUTSIDE OF THE VERSACROSS DILATOR AT THE TIME THE PERFORATION OCCURRED, ALTHOUGH NO RESISTANCE WAS FELT WHILE MANEUVERING THE CATHETER; RESISTANCE WAS ONLY NOTED WITH THE WIRE PRIOR TO ATTEMPTING TRANSSEPTAL ACCESS. NO GUIDEWIRE WAS USED DURING THE PROCEDU

  Patient problems: Perforation; Perforation of Vessels

  MAUDE report 25301320 ↗
• InjuryMay 18, 2026Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  DURING A PULSE FIELD ABLATION (PFA) A FARADRIVE STEERABLE SHEATH CLEAR AND VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE WAS SELECTED FOR USE. PFA AF ABLATION. RIGHT FEMORAL ACCESS WAS OBTAINED USING A SHORT 6FR SHEATH AND A 7FR SHEATH UNDER ULTRASOUND GUIDANCE, AND HEPARIN WAS ADMINISTERED. THE VERSACROSS CONNECT (VCC) PIGTAIL WAS ADVANCED, FOLLOWED BY EXCHANGING THE VCC WITH DILATOR OVER THE 6FR SHEATH. THERE WAS DIFFICULTY ADVANCING THE SHEATH OVER THE WIRE, LEADING TO THE USE OF PERIPHERAL DILATORS. THE TEAM THEN SWITCHED FROM THE VCC DILATOR TO THE FD DILATOR, WHICH PROVIDED SOME IMPROVEMENT, BUT ADVANCEMENT WAS STILL UNSUCCESSFUL. SIGNIFICANT BLEEDING DEVELOPED AT THE PUNCTURE SITE, AND THE FIRST ACT MEASURED 406 SECONDS. IT WAS DETERMINED THAT A SMALL ARTERIOLE HAD BEEN PUNCTURED AND POSSIBLY WIRED, RESULTING IN A LIKELY SMALL VESSEL TEAR THAT WAS MANAGED WITH MANUAL PRESSURE. AN ATTEMPT WAS MADE TO OBTAIN LEFT FEMORAL VEIN ACCESS, BUT ULTRASOUND SHOWED THE FEMORAL ARTERY POSITIONED ABOVE THE VEIN, PREVENTING ACCESS. THE PROCEDURE WAS ABORTED, HEPARIN WAS REVERSED WITH PROTAMINE, AND ANESTHESIA WAS DISCONTINUED WITH THE PATIENT EXTUBATED IN THE EP LAB. THE PATIENT WAS ADM

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

  MAUDE report 25211205 ↗