WATCHMAN FXD Curve™ Access System M635TU80020Recalls & reported problems

Summary

The FDA's MAUDE database contains 654 adverse event reports that list this exact device (DI 00191506013813), received between Feb 10, 2022 and Sep 30, 2026 — classified as 47 deaths, 557 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (31 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jul 29, 2025Class IOpen, Classified

   Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.

   Z-2435-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 654 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949833 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported thrombosis occurred. A left atrial appendage closure (LAAC) procedure was being performed. A WATCHMAN FXD Double Curve Access System (WAS) and a 24mm WATCHMAN FLX Pro LAA Closure Device and Delivery System (WDS) was selected for use. Transseptal puncture was successfully completed, and the activated clotting time (ACT) was 373 seconds. The WAS was inserted, and a 24mm WDS was advanced and deployed. After assessment, the 24mm WDS was determined to be undersized. The device was recaptured, removed, and exchanged for a larger 27mm WDS. As the 27 mm WDS was introduced through the WAS, transesophageal echocardiography (TEE) revealed a long, fibrous clot within the left atrial appendage. The 27mm WDS was removed from the sheath, and the physician aspirated 30mL of blood through the WAS. Following aspiration, the clot was no longer visualized on TEE; however, no clot was identified in the aspirated blood. The physician then reintroduced and began advancing the same WDS. As the device approached the tip of the WAS sheath, the same fibrous clot was again observed on TEE. The device was removed, and aspiration was repeated, this time with 50mL of blood. The clot again disappe

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50932308 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 50824656 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that asystole occurred.A left atrial appendage (LAA) closure procedure was being performed under intracardiac echocardiography (ICE) and transesophageal echocardiography (TEE) guidance using a WATCHMAN FXD Double Curve Access System (WAS) and VersaCross Connect. While the physician was coming down from the superior vena cava in preparation for transseptal puncture with both devices, the patient developed asystole lasting approximately 20 to 30 seconds. External pacing was initiated, and the patient subsequently returned to atrial fibrillation. Imaging confirmed no pericardial effusion, and the physician elected to proceed with the procedure. Prior to WATCHMAN Closure Device implantation, cardioversion was attempted but was unsuccessful in restoring sinus rhythm. The procedure was completed as planned. The patient remained stable with no further reported complications. The patient was discharged the same day.

  Patient problems: Asystole

  MAUDE report 50805549 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that air embolism and ST segment elevation occurred.A left atrial appendage (LAA) closure procedure was performed, and a WATCHMAN FXD Curve Access System (WAS) was selected to be used. During the procedure the physician performed pre-imaging to see the size and morphology of the appendage as well as evaluate for baseline effusion, which there was no effusion during this procedure. The physician gets access in the right femoral vein, using a non-Boston Scientific (BSC) micropuncture kit and a standard J-wire. After gaining access, the physician inserted the non-BSC Fast-Cath sheath over a standard non-BSC J-wire. Once the sheath and J-wire were advanced into the superior vena cava (SVC), the physician removed the standard non-BSC J-wire, inserted the non-BSC BRK needle, and began the process of crossing the septum to access the left atrium. Using transesophageal echocardiography (TEE), the physician assessed the position on the septum to confirm appropriate tenting and access location. The physician punctured the inferior-mid portion of the septum with the non-BSC BRK needle. After crossing the septum, the physician advanced the non-BSC Fast-Cath sheath into the left

  Patient problems: Air Embolism; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes

  MAUDE report 50777886 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a pericardial effusion occurred. A left atrial appendage closure (LAAC) procedure was being performed. A WATCHMAN FXD Curve Access System (WAS) and a WATCHMAN LAA Closure Device & Delivery System (WDS) was selected for use. The initial transeptal puncture (TSP) was performed using VersaCross. While attempting to cross the interatrial septum with Intracardiac Echo (ICE) imaging, an effusion was noted. A Transesophageal Echocardiography (TEE) imaging probe was placed in the patient to monitor the effusion while the physician proceeded with the WATCHMAN implant procedure. There was no intervention required. The Closure Device was implanted in the LAA. The patient stayed in the hospital overnight for observation and discharged the following day with no further complications reported.

  Patient problems: Pericardial Effusion

  MAUDE report 50735304 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that pericardial effusion and cardiac tamponade occurred.A left atrial appendage (LAA) closure procedure was being performed, and a WATCHMAN FXD Curve Access System (WAS) was selected to be used. During the procedure, access was obtained via the groin for the WAS sheath and an additional sheath for intra cardiac echocardiography (ICE). VersaCross Connect was used in conjunction with ICE to cross the atrial septum at an inferior-mid location. The wire crossed the septum, and position was confirmed by ICE without issue. The WAS sheath was advanced and retracted to dilate septal puncture. The ICE catheter was advanced across the septum uneventfully and measurements of the LAA were obtained. The WAS sheath was advanced to the left atrium, a pigtail catheter was inserted and an angiogram was performed. The patient's blood pressure was low, so an effusion sweep was performed with ICE, and a large pericardial effusion was noted on the right ventricle (RV) free wall. The patient's chest was prepped and pericardiocentesis was performed. A total of 400cc of bright red blood was aspirated, and the patient required one (1) unit of blood transfusion. The sheaths were removed and

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

  MAUDE report 50671278 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50600742 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a cardiac perforation and pericardial effusion occurred. A left atrial appendage (LAA) closure procedure was being performed. A WATCHMAN FXD Curve Access System (WAS) and a WATCHMAN LAA Closure Device & Delivery System (WDS) were selected for use. During the initial transeptal puncture (TSP) using the WAS and VersaCross Connect system, Intracardiac Echo (ICE) was difficult to visualize the left atrium (LA). The VersaCross Connect wire was tented, and while preparing to buzz across the left atrium (LA), it was noted the WATCHMAN FXD Curve sheath and dilator had not advanced over to the LA. The physician pulled back the wire to recross, noting again, the sheath and dilator had not advanced over the interatrial septum. At this time, it was noted the wire had perforated the aorta. Physician observed a small circumferential pericardial effusion, noting it was not large enough to drain/treat. Transesophageal echocardiography (TEE) and computed tomography (CT) imaging was also completed as part of the assessment. The patient had stable blood pressure, and the implant procedure was discontinued. The patient remained in the hospital for three days. There were no further comp

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 50548864 ↗
• MalfunctionAug 20, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  It was reported that a kink occurred, and the procedure was cancelled.A left atrial appendage (LAA) closure procedure was being performed, and a WATCHMAN FXD Curve Access System (WAS) was selected to be used. The patient was sedated with general anesthesia. During the procedure, transeptal puncture (TSP) was performed in an inferior/posterior location and the physician approached using a WAS. An attempt was made to deploy the 40mm closure device; however, interference from the posterior pectinate caused the closure device to pop out, resulting in significant protrusion. The WAS sheath was severely bent and replacing it was unlikely to resolve the issue. Furthermore, due to insufficient space to select an alternative TSP site, the procedure was discontinued at the physician's discretion.It was further reported that there was no report that the WATCHMAN Access System was kinked and that the report does not indicate that the 40mm Closure Device and Delivery System was bent. It was reported that the sheath was on a severely angulated trajectory, and changing the sheath was not expected to resolve the issue. Therefore, the complaint will be considered non-reportable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50358895 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that thrombosis occurred.A left atrial appendage (LAA) closure procedure was being performed. A WATCHMAN FXD Curve Access System (WAS) and a WATCHMAN FLX LAA Closure Device & Delivery System (WDS) were selected to be used. The physician inserted the WAS and positioned the device in the LAA of the patient. The WDS was prepared and ready to be inserted when a thrombus was noted adhering to the pigtail catheter upon its removal from the left atrial appendage. The physician administered an additional 7,000 units of heparin and then continued the procedure. The procedure was then successfully completed with the closure device implanted in the LAA of the patient. There were no other complications that were reported to have occurred as a result of this event.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50288795 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a pericardial effusion occurred.A left atrial appendage closure (LAAC) procedure was being performed. It was noted that the patient had a small baseline pericardial effusion prior to the procedure. A WATCHMAN FXD Double Curve Access System (WAS) and a WATCHMAN FLX Pro LAA Closure Device and Delivery System (WDS) was selected for use. Vascular access was obtained via the groin, and a VersaCross Connect system was utilized to perform the transseptal puncture (TSP). After several attempts, transseptal access was successfully achieved in a mid/mid position. At this time, the patient developed cardiac tamponade, and a circumferential pericardial effusion surrounding the right atrium and right ventricle began to develop. The procedure was cancelled and pericardiocentesis with a pericardial window was performed. Approximately 1 to 2 liters of fluid was drained and transfused back to the patient. The patient remained hospitalized for recovery but has since been discharged.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50288752 ↗
• MalfunctionAug 14, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255875 ↗
• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50244650 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that pericardial effusion occurred. A left atrial appendage closure (LAAC) procedure was being performed. The physician was attempting to go transeptal and noticed a small pericardial effusion. The physician had slipped into the coronary sinus with the pigtail catheter. The patient was given protamine and the effusion remained stable. The procedure was discontinued. The patient was monitored and will have follow up echocardiography imaging to evaluate for effusion.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 50229887 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that there was a perforation. A left atrial appendage (LAA) closure procedure was being performed. A WATCHMAN FXD Curve Access System (WAS) and a WATCHMAN FLX Pro LAA Closure Device & Delivery System (WDS) were selected to be used. The physician had some difficulty performing the transseptal puncture. The physician had to rewire up the superior vena cava a few times due to a narrow septal opening before being able to cross. The WAS and VersaCross Connect wire both went across without excessive force. Fluoroscopy showed that the devices were seated in the pulmonary vein, but this was hard to tell via Transesophageal Echocardiogram (TEE). The physician tried getting into the LAA and continued to have difficulty. A contrast shot was performed, and the physician tried to pull back blood but was unable to. The physician was finally able to track that the was in the pericardium. The CT surgeon also agreed it was hard to determine the positioning of the WAS. The patient was then brought up to the operating room to be further evaluated. A sternotomy was performed where the patient was stitched and had their appendage clipped. There were no other complications that were repo

  Patient problems: Cardiac Perforation

  MAUDE report 50174133 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a cardiac perforation occurred.A left atrial appendage closure (LAAC) procedure was being performed. A WATCHMAN FXD Double Curve Access System (WAS) and a WATCHMAN LAA Closure Device & Delivery System (WDS) were selected for use. After achieving femoral access, a transseptal puncture (TSP) was performed. As physician attempted to access the left superior pulmonary vein (LSPV), the 5 Fr angled pigtail catheter was difficult to insert into the ostium, and switched out for a 4 Fr MTAKA catheter. Using a guidewire to access the anterior lobe, contrast imaging was used to improve visualization. Faint contrast flow was observed from the anterior lobe into the left atrium, where it pooled, when physician suspected a perforation had occurred. Transesophageal echocardiography (TEE) and transthoracic echocardiogram (TTE) were performed and there was no pericardial effusion observed. Patient's blood pressure dropped and norepinephrine was administered to increase pressure. Following a period of observation, the procedure resumed, implanting the closure device. TEE and TTE were performed a second time, and there was no increase in pericardial fluid noted. The patient remained i

  Patient problems: Cardiac Perforation; Low Blood Pressure/ Hypotension

  MAUDE report 50173896 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a perforation occurred.A left atrial appendage closure (LAAC) procedure was being performed. It was noted that the patient had a trace baseline pericardial effusion prior to the procedure. A WATCHMAN FXD Double Curve Access System (WAS) and a 27mm WATCHMAN FLX Pro LAA Closure Device and Delivery System (WDS) was selected for use. The physician was advancing the 27mm WDS through the WAS sheath, and as the device approached the distal marker, the WAS sheath lifted to the anterior side of the ridge. The physician suspected the WAS sheath may have perforated a small portion of the ridge on the limbus side of the appendage, near the ostium, although this was not confirmed via imaging. There was no clinical effect, and the baseline effusion did not show a notable difference. The Closure Device was successfully implanted, and the suspected perforation site was covered by the WATCHMAN Closure Device. There were no patient complications, and the patient was discharged the next day.

  Patient problems: Cardiac Perforation

  MAUDE report 50143177 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that thrombosis occurred. A left atrial appendage (LAA) closure procedure was being performed, and a WATCHMAN FXD Curve Access System (WAS) was selected to be used. During the procedure, after confirming spontaneous echo contrast (SEC) positivity, the physician recommended maintaining the activated clotting time (ACT) above 300 seconds, which is higher than the standard target. The right femoral puncture was performed, and 5,000 units of heparin was administered, and the ACT was 377 seconds. After confirming pigtail movement from the pulmonary vein (PV) to the LAA, echocardiography revealed findings suspicious for a string-like thrombus attached to the WAS sheath. The procedure was interrupted and the ACT was re-measured. The echocardiographer suggested to the physician to administer Dobutamine in order to initiate washout as the spontaneous echo contrast was severe. The suspected string-like thrombus was no longer visible and Dobutamine was administered. The ACT was 273 seconds, and 2,000 units of heparin were administered. The spontaneous echo contrast gradually resolved. The previously observed thrombus could no longer be identified anywhere on echocardiography.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50089824 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported pericardial effusion and cardiac tamponade occurred. A left atrial appendage closure (LAAC) procedure was being performed. A WATCHMAN FXD Double Curve Access System (WAS) was selected for use. The initial transeptal puncture (TSP) was performed using a non-Boston Scientific (BSC) needle and Intracardiac Echo (ICE) imaging. TSP was difficult to visualize tenting and positioning of the needle on the septum. Following TSP, the physician advanced the WAS sheath. Several minutes later, the patient experienced a pericardial effusion followed by cardiac tamponade. A pericardiocentesis was performed to treat the effusion, draining approximately 2200 ml of blood, which was transfused back to the patient. The physician was able to successfully clip the appendage, and the LAAC implant procedure was cancelled due to emergent need to stabilize the patient. The patient remained in the hospital for several days while they recover.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50069970 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced ST segment elevation. A left atrial appendage (LAA) closure procedure was being performed. A WATCHMAN FXD Curve Access System (WAS) and a WATCHMAN FLX Pro LAA Closure Device & Delivery System (WDS) were selected to be used. The physician performed the transseptal puncture and positioned the WAS in the LA of the patient. It was at this time that the patient's ECG showed ST segment elevation. No air was visualized on fluoroscopy when the pigtail catheter was advanced. The procedure was paused at this time to monitor the patient. There were no changes to any other vital signs and anesthesia did not need to alter their support to the patient. The ST segment elevation resolved on its own after about 4 minutes. LA pressure was recorded, contrast image was taken of the LAA, final decision on device size was made, device was prepped, advanced and deployed. After two (2) full recaptures were performed the closure device was able to be successfully implanted in the LAA of the patient. All the devices were removed from the patient. The physician was unable to control the bleeding at the groin site. Surgery was requested to scrub in and evaluated th

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Non specific EKG/ECG Changes; Perforation of Vessels

  MAUDE report 50054023 ↗
• InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CARDIAC PERFORATION AND PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS BEING PERFORMED. A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS) AND A WATCHMAN CLOSURE DEVICE AND DELIVERY SYSTEM (WDS) WERE SELECTED FOR USE. WHILE ATTEMPTING THE GET THE WAS AND VERSACROSS ON THE SEPTUM, THE PHYSICIAN KEPT FALLING POSTERIOR AND INFERIOR. AFTER MULTIPLE ATTEMPTS TO GET HIGHER AND MORE ANTERIOR IT WAS DECIDED TO RESHAPE THE SHEATH. THE PHYSICIAN REMOVED THE DILATOR, SHAPED IT AND RE-ADVANCED THE DILATOR. THE WHOLE SYSTEM WAS ADVANCED UP THE INFERIOR VENA CAVA (IVC). A PERICARDIAL SWEEP WAS PERFORMED, AND A CONSIDERABLE PERICARDIAL EFFUSION WAS NOTED. THE WAS AND DILATOR PERFORATED THE LATERAL WALL AT SOME POINT. THE PHYSICIAN DETERMINED A PERICARDIAL TAP WAS NEEDED. 200CC OF DULL RED FLUID WAS REMOVED AND RE-TRANSFUSED BACK TO THE PATIENT. A DRAIN WAS PLACED AND THE PATIENT WAS BROUGHT TO THE INTENSIVE CARE UNIT (ICU) IN STABLE CONDITION.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 25894506 ↗
• InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS BEING PERFORMED. A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS) AND A 20MM WATCHMAN FLX PRO CLOSURE DEVICE AND DELIVERY SYSTEM (WDS) WERE INITIALLY SELECTED FOR USE. THE TRANSEPTAL PUNCTURE (TSP) WAS DIFFICULT TO CROSS THE SEPTUM DUE TO THE SEPTAL ORIENTATION, AND THE PRESENCE OF DEFIBRILLATION LEADS IN THE RIGHT ATRIUM. AFTER TWO ATTEMPTS, THE PHYSICIAN USED A DIFFERENT VERSACROSS SYSTEM AND EXCHANGED FOR THE WAS SHEATH AFTER CROSSING. PERICARDIAL EFFUSION WAS NOTED POST TSP, SO THE PHYSICIANS MONITORED IT THROUGHOUT THE PROCEDURE. THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO PLACE THE INTRACARDIAC ECHO (ICE) PROBE IN THE LA. CONTRAST WAS SHOT INTO THE LAA AND THE DEVICE SIZING WAS DETERMINED. THE 20MM DEVICE WAS PLACED INTO THE LAA AND REJECTED FOR SIZING. A 24MM DEVICE WAS THEN SELECTED. AFTER TWO FULL RECAPTURES, THE PHYSICIAN DETERMINED THE DEVICE WAS PLACED PROPERLY BASED ON THE TUG TEST AND CONTRAST SHOT. FULL POSITION, ANCHOR, SIZE AND SEAL (PASS) CRITERIA WERE NOT USED DUE TO ICE REMAINING IN THE RIGHT ATRIUM. AFTER THE WDS WAS REMOVED, ICE WAS BROUGHT TO THE LEFT SIDE FOR FIN

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 25893256 ↗
• MalfunctionJul 21, 2026Air/Gas in Device

  It was reported that there was air within the sheath. A left atrial appendage closure (LAAC) procedure was being performed. A WATCHMAN FXD Curve Access System (WAS) and a 27mm WATCHMAN Closure Device and Delivery System (WDS) were selected for use. The WAS was introduced into the left atrium using a pigtail wire. The physician set up for a contrast shot. Prior to injecting the contrast, the physician stepped on fluoroscopy. An 8mm bubble was noted in the WAS. The physician aspirated the WAS and pulled back the air. The patient was stable for the remainder of the procedure. The physician reports the patient was doing well and planned to discharge the patient the next day.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25892702 ↗
• InjuryJul 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS BEING PERFORMED. A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS) AND A 24 MM WATCHMAN FLX PRO LAA CLOSURE DEVICE AND DELIVERY SYSTEM (WDS) WERE SELECTED FOR USE. INTRACARDIAC ECHO (ICE) IMAGING WAS USED INITIALLY BUT WAS DIFFICULT TO SEE DUE TO THE PATIENT ANATOMY. THE REMAINDER OF THE CASE WAS COMPLETED UNDER TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) GUIDANCE. PRE-IMAGING WAS COMPLETED TO SEE THE SIZE AND MORPHOLOGY OF THE APPENDAGE AS WELL AS TO SCAN FOR AN EFFUSION. THERE WAS NO TRACE EFFUSION NOTED. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL VEIN. A STANDARD J-WIRE WAS INSERTED IN THE INFERIOR VENA CAVA (IVC) TO THE SUPERIOR VENA CAVA (SVA), FOLLOWED BY THE DOUBLE CURVE SHEATH AND THE VERSACROSS CONNECT. THE J-WIRE WAS REMOVED AND REPLACED WITH RF WIRE. THE PHYSICIAN USED TEE FOR PROPER POSITIONING FOR THE TRANSEPTAL PUNCTURE (TSP). DUE TO THE ANATOMY OF THE PATIENT, THE TSP WAS LIMITED ON WHERE IT COULD CROSS THE SEPTUM. AFTER THE TSP, THE RF WIRE WAS ADVANCED INTO THE LA, WHERE IT DID FALL INTO THE MITRAL VALVE MULTIPLE TIMES. THE PHYSICIAN DID HAVE DIFFICULTY ATTEMPTING TO ADVANCE TH

  Patient problems: Pericardial Effusion

  MAUDE report 25847635 ↗