EZ Steer NAV DS BN7TCDF8LRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10846835003000), received between Feb 23, 2018 and Feb 3, 2026 — classified as 5 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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. 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH AN EZ STEER NAV DS CATHETER AND OBSERVED AN ELECTRODE WITH LIFTED OR SHARP RINGS. NOTICED DURING INITIAL TEST, THE TIP OF THE CATHETER AND ELECTRODES COMPRESSED. CATHETER WAS REPLACED. THE PROCEDURE WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 12-JAN-2026. THERE WAS PHYSICAL DAMAGE ON THE TIP. DAMAGE DID NOT RESULT IN WIRES BEING EXPOSED. THE DAMAGE DID RESULT IN LIFTED OR SHARP RINGS. THE DEVICE WAS NOT PRE-SHAPED. THE INITIALLY REPORTED ¿TIP OF THE CATHETER AND ELECTRODES COMPRESSED¿ EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 12-JAN-2026 THAT THE DAMAGE RESULTED IN LIFTED OR SHARP RINGS AND HAVE ASSESSED THE ELECTRODE WITH LIFTED OR SHARP RINGS ISSUE AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 12-JAN-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254830 ↗
• MalfunctionAug 12, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A EZ STEER NAV DS WHICH HAD DEFLECTION STUCK. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THE EZ STEER NAV DS HAD A DEFLECTION ISSUE DURING THE PROCEDURE. THE CALLER STATED THE D CURVE WAS NOT WORKING. THE CALLER STATED THE CATHETER WOULD NOT DEFLECT. THE CALLER STATED THE CATHETER WAS REMOVED FORM THE BODY AND THE TIP WAS STRAIGHTENED OUT. THE PROCEDURE CONTINUED. THE CALLER STATED THE PHYSICIAN OPTED OUT OF REPLACING THE CATHETER. THE CUSTOMER'S REPORTED DEFLECTION ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 5-AUG-2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE CATHETER WAS ACTUALLY STUCK IN A PARTIAL DEFLECTION. CATHETER COULD NOT DO THE F CURVE. THERE WAS NO DIFFICULTY WITHDRAWING THE CATHETER AND NO DAMAGE TO ANY ELECTRODES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790313 ↗
• MalfunctionJul 28, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT-SIDED ATRIAL FLUTTER ABLATION PROCEDURE WITH A EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND POST PROCEDURE, THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A BROKEN TIP WITH EXPOSED WIRING. DURING THE PROCEDURE, THE PHYSICIAN STATED THAT THE DEFLECTION WAS NOT ADEQUATE AND THE CATHETER WAS NOT MANEUVERING APPROPRIATELY. THE CATHETER WAS REMOVED FROM THE PATIENT AND IT WAS NOTICED THAT THE CATHETER HAD A KINK IN THE SHAFT. THE CATHETER WAS REPLACED. THE PROCEDURE WAS CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628592 ↗
• MalfunctionOct 9, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TYPICAL FLUTTER ABLATION PROCEDURE WITH AN EZ STEER NAV DS FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A SMALL CRACK NEAR THE SECOND RING. DURING THE PROCEDURE, THERE WAS AN ISSUE ON THE DEFLECTION OF THE TIP OF THE ABLATION CATHETER. THE CATHETER DID NOT BEND PROPERLY. ANOTHER CATHETER WAS USED IN ORDER TO COMPLETE THE PROCEDURE SUCCESSFULLY. LENGTHENING OF PROCEDURE TIME WAS OF APPROXIMATELY 3 MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 18-SEP-2024 OBSERVED IT BENT AND SMALL CRACK NEAR THE SECOND RING. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF THE SMALL CRACK NEAR THE SECOND RING ON 18-SEP-2024 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407292 ↗
• MalfunctionOct 26, 2023

  NOISY SIGNALS ON ABLATION CATHETER THAT HAD ENTERED THE PATIENT'S BODY. CABLE FOR ABLATION CATH EXCHANGES X2 WITH NO CHANGE. NO HARM DONE TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18010970 ↗
• MalfunctionSep 21, 2023Material Separation; Positioning Problem; Material Separation; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER - RIGHT ABLATION PROCEDURE WITH A EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND THE PHYSICIAN STATED THAT THE CATHETER WAS NO LONGER DEFLECTING AND WAS NOT GETTING GREAT CONTACT. THE DEVICE WAS "VISUALLY BROKEN", WHICH THE PHYSICIAN CONFIRMED TO MEAN THAT THE CATHETER WAS BENT AT THE TIP. THE DAMAGE WAS DONE AT THE VERY DISTAL PORTION OF THE CATHETER. THERE WERE NO EXPOSED WIRES, LIFTED RINGS, OR SHARPENED RINGS. THERE WAS NO RESISTANCE OR DIFFICULTY DURING INSERTION OR REMOVAL OF THE CATHETER. THE CATHETER WAS NO PRE-SHAPED. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17791155 ↗
• MalfunctionMar 3, 2022Signal Artifact/Noise; Communication or Transmission Problem

  CATHETER INSERTED AND ALL ELECTRODES WENT BLACK DURING ABLATION. NO INFORMATION WAS TRANSMITTABLE TO CARTO ((01) (B)(4)). NEW CATHETER UTILIZED AND ISSUE RESOLVED. NO ADVERSE HARM TO PATIENT. REP CALLED IN PRODUCT. CATHETER INSERTED, BAD ELECTRODE, NOISY SIGNAL (01)(B)(4). NO ADVERSE HARM TO PT. NEW CATHETER UTILIZED W/O ISSUES. REP CALLED IN PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13659025 ↗
• InjuryDec 10, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT ((B)(6) KGS) UNDERWENT AN ATRIAL FIBRILLATION (AFIB)/ ATRIAL FLUTTER (AFLUTTER) ABLATION PROCEDURE WITH A (B)(6) NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING SURGICAL INTERVENTION. IT WAS REPORTED THAT WHILE ABLATING THE CAVO-TRICUSPID ISTHMUS (CTI) LINE, THE PHYSICIAN HEARD A STEAM POP AND IT WAS NOTICED THE PATIENT HAD PERICARDIAL EFFUSION. THE EFFUSION WAS CONFIRMED VIA THE PATIENT'S BLOOD PRESSURE DECLINING AND VIA THE ICE CATHETER. A PERICARDIOCENTESIS WAS DONE AND 970 CCS OF FLUID WERE REMOVED. THE PATIENT IS GOING TO THE OPERATING ROOM (OR) FOR SURGICAL REPAIR. THE PATIENT WAS NOT STABLE WHEN THEY LEFT THE ROOM FOR THE OR AND THE REPORTER HEARD THAT WHEN THE PATIENT ARRIVED IN THE OR THEIR BLOOD PRESSURE DROPPED AGAIN. THE REPORTER DID NOT SPEAK TO THE PHYSICIAN. THE REPORTER STATED THEY WERE USING AN 8 MM "DF" CURVE ABLATION CATHETER, BWI CS CATHETER, ACCUNAVE CATHETER, AND CRYO SHEATH. THE ABLATION CATHETER DID NOT GO INTO THE LEFT SIDE OF THE HEART ONLY THE CYRO. THE SMARTABLATE GENERATOR WAS SET FOR 70 WATTS AND 60 DEGREES, BUT THEY THINK THEY ONLY USED 65 WATTS. ADDITIONAL

  Patient problems: Cardiac Tamponade

  MAUDE report 12974554 ↗
• MalfunctionDec 3, 2021Use of Device Problem; Human-Device Interface Problem

  STEAM POP OCCURRED DURING RF CTI (RADIOFREQUENCY CAVOTRICUSPID ISTHMUS) ABLATION. PATIENT DEVELOPED ACUTE HEMOPERICARDIUM WITH TAMPONADE REQUIRING EMERGENT PERICARDIOCENTESIS, TAKEN TO OR (OPERATING ROOM) FOR REPAIR OF RIGHT ATRIAL PERFORATION.

  Patient problems: Cardiac Perforation; Cardiac Tamponade

  MAUDE report 12922833 ↗
• MalfunctionJun 30, 2021Signal Artifact/Noise; Mechanical Jam; Signal Artifact/Noise; Mechanical Jam

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN ATRIAL FLUTTER RIGHT (R-AFL) ABLATION PROCEDURE WITH A EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER. THE CATHETER WAS STUCK IN DEFLECTION. THE CATHETER WAS REMOVED FROM THE PATIENT AND IT WAS NOTICED THE CATHETER WAS PERMANENTLY BENT AFTER THE FIRST USE, AND THE DISTAL ELECTRODES DID NOT DISPLAY ON THE CARTO 3 SYSTEM AND THE RECORDING SYSTEM. THE DISTAL ELECTRODES DISPLAYED AS NOISE OR NO SIGNAL AT ALL WHEN THE CATHETER WAS TORQUED OR BENT. AFTER IT WAS USED AGAIN IS WHEN THE ISSUE WITH THE DISTAL ELECTRODES OCCURRED. THEY REPLACED THE CATHETER AND THE ISSUE WAS RESOLVED. THE CASE CONTINUED WITHOUT ANY FURTHER INCIDENT. NO PATIENT CONSEQUENCES WERE REPORTED. THE CATHETER WAS NOT PERMANENTLY BENT. THE ISSUE APPEARED WHEN THE CATHETER WAS FULLY TORQUED. THE NOISE ISSUE IS NOT MDR-REPORTABLE. THE STUCK DEFLECTION IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12090251 ↗
• InjuryApr 23, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD MALE PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) ABLATION PROCEDURE WITH EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING RADIOFREQUENCY ABLATION OF THE CAVOTRICUSPID ISTHMUS (CTI), THE PATIENT BECAME HYPOTENSIVE AND PERICARDIAL EFFUSION WAS DIAGNOSED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). PERICARDIOCENTESIS WAS PERFORMED TO DRAIN THE FLUID FROM THE PERICARDIAL SPACE. PATIENT WAS REPORTED IN STABLE CONDITION AND HAD FULLY RECOVERED. PROLONGED HOSPITALIZATION WAS NOT REQUIRED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE EVENT IS THAT IT WAS PROCEDURE RELATED. NO BWI PRODUCT MALFUNCTION WAS REPORTED. TRANSSEPTAL PUNCTURE WAS DONE WITH A BAYLIS NEEDLE. THERE WAS NO EVIDENCE OF STEAM POP DURING THE ABLATION. STANDARD FLOW SETTINGS WERE USED. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THE PUMP WAS SWITCHING FROM LOW TO HIGH FLOW DURING THE ABLATION. THE FORCE VISUALIZATION FEATURES USED INCLUDED GRAPH, DASHBOARD, VECTOR AND VISITAG. THE PARAMETERS FOR STABILITY USED WITH THE VISITAG MODULE WERE 3 MM 3 SEC 25% OVER 3 3 MM. TIME WAS USED AS COLORING O

  Patient problems: Cardiac Tamponade

  MAUDE report 11713740 ↗
• MalfunctionApr 19, 2021No Display/Image

  BIOSENSE WEBSTER NAV 8MM EZ STEER NAV DS BI-DIRECTIONAL EP (ELECTROPHYSIOLOGY) CATHETER WAS NOT ABLE TO BE VIEWED ON SCREEN. CATHETER ICON DISPLAYED INCORRECTLY. REPLACED CATHETER AND ISSUE WAS RESOLVED.

  Patient problems: Insufficient Information

  MAUDE report 11684588 ↗
• InjuryApr 1, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE ((B)(6) KG) PATIENT WITH HISTORY OF LEFT-SIDED ACCESSORY PATHWAY CONDUCTION, UNDERWENT AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT) /WOLFF-PARKINSON-WHITE (WPW) ABLATION PROCEDURE WITH AN UNKNOWN EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED COMPLETE HEART BLOCK WITH CONDUCTION THROUGH LEFT-SIDED ACCESSORY PATHWAY. DURING THE AVRT PROCEDURE, AFTER USE OF BWI PRODUCTS, WHEREIN NO ABLATION WAS PERFORMED, AN AV NODE BLOCK WAS DISCOVERED AS THE SHAPE OF THE QRS ON THE CARTO 3 AND THE RECORDING SYSTEM CHANGED. THE PHYSICIAN CONFINED IT AFTER PACING NEAR THE AV NODE AND THE SYSTEM WAS NOT USING THE AV NODE. NO MEDICAL INTERVENTION WAS OFFERED. THE PATIENT WAS UNDER MONITORING AS THIS MAY BE TEMPORARY AND THE CONDUCTION CAN RETURN. PATIENT WAS STILL ABLE TO CONDUCT FROM ATRIA TO VENTRICLES DURING COMPLETE HEART BLOCK DUE TO PRESENCE OF ACCESSORY PATHWAY. THE PATIENT WAS REPORTED TO BE IN A STABLE CONDITION. THE PATIENT DID REQUIRE EXTENDED HOSPITALIZATION STAY BECAUSE OF THE ADVERSE EVENT. THE PHYSICIAN RECOMMENDED ADMITTING PATIENT OVERNIGHT TO MONITOR HEART BLOCK AND CONDUCTION. THE PHYSICIAN¿S OPINION ON THE CA

  Patient problems: Heart Block

  MAUDE report 11600819 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT IN HIS 60S, WEIGHING (B)(6) LBS. WITH HISTORY OF PREVIOUS PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE, UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE ABLATION PHASE OF THE PROCEDURE, WHILE MANEUVERING THE EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER IN THE LEFT ATRIUM (LA), THE EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER SUDDENLY CAME BACK INTO THE RIGHT ATRIUM (RA) AND A DROP-IN THE PATIENT¿S BLOOD PRESSURE WAS NOTICED BY ANESTHESIOLOGIST. CARDIAC TAMPONADE WAS CONFIRMED VIA AN ACUNAV ULTRASOUND CATHETER. THE LOCATION OF THE EFFUSION IS UNKNOWN. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 350ML OF FLUID FROM THE PERICARDIAL SPACE, AND THE DRAINAGE WAS LEFT IN PLACE. THE PATIENT RECOVERED FULLY IN PROCEDURE ROOM AFTER PERICARDIAL DRAINAGE AND WAS ADMITTED FOR OVERNIGHT OBSERVATION IN THE INTENSIVE CARE UNIT (ICU). IT IS UNKNOWN IF EXTENDED HOSPITALIZATION WAS REQUIRED. PATIENT'S OUTCOME IS FULLY RECOVERED. PHYSICIAN IS UNSURE OF REASON FOR EFFUSION. TRANSSEPTAL PUN

  Patient problems: Cardiac Tamponade

  MAUDE report 10256038 ↗
• MalfunctionDec 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR RIGHT ATRIAL FLUTTER WITH A EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER, AND A BROKEN TIP ISSUE OCCURRED. THERE WAS SOME RESISTANCE WHEN INSERTING THE CATHETER. WHEN THE CATHETER WAS PULLED, THE TIP WAS BENT WITH EXPOSED WIRES. HOWEVER, THERE WERE NO SHARP OR LIFTED RINGS. CATHETER REPLACEMENT RESOLVED THE ISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE OBSERVED BROKEN TIP HAS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9419549 ↗
• MalfunctionAug 8, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) WITH AN EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER. DURING THE PROCEDURE, A SENSOR ERROR (UNSPECIFIED) DISPLAYED ON THE CARTO 3 SYSTEM. CATHETER CABLE WAS REPLACED AND THE ISSUE PERSISTED. EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THERE WERE NO DIFFICULTIES MANEUVERING THE EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER. UPON VISUAL INSPECTION OF CATHETER # 1, AN EXPOSED WIRE WAS OBSERVED NEAR THE DISTAL ELECTRODE. THERE WERE NO PATIENT CONSEQUENCES. THE MAGNETIC SENSOR ERROR WAS ASSESSED AS NOT REPORTABLE. THE POTENTIAL RISK THAT A MAGNETIC SENSOR ERROR COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS DETERIORATION IN THE PATIENT¿S STATE OF HEALTH WAS REMOTE. THE EXPOSED WIRE OBSERVED NEAR THE DISTAL ELECTRODE WAS ASSESSED AS A REPORTABLE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7766180 ↗
• InjuryFeb 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A CAVOTRICUSPID ISTHMUS (CTI) ABLATION PROCEDURE FOR ATRIAL FLUTTER WITH AN EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING SURGICAL INTERVENTION. DURING CTI ABLATION, THE PATIENT BECAME HYPOTENSIVE AND EXHIBITED A VASOVAGAL-LIKE REACTION. REMAINDER OF PROCEDURE WAS ABORTED. ON POST-PROCEDURE DAY 1, THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE, REPORTING NAUSEA AND A SORE THROAT, HOWEVER WAS COMPETENT. A PERICARDIAL EFFUSION WAS DETECTED VIA ECHOCARDIOGRAM AND A PERICARDIAL WINDOW WAS PERFORMED. PATIENT WAS REPORTED TO BE IN STABLE CONDITION ON ANTI-ARRHYTHMIC AGENTS. IT IS BELIEVED THE PATIENT REQUIRED EXTENDED HOSPITALIZATION DUE TO THE EVENT, HOWEVER IT IS NOT CONFIRMED. LOCATION OF THE INJURY AND CAUSE IS UNKNOWN. THERE WERE NO PATIENT FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. INITIALLY, THE PHYSICIAN SUSPECTED THE HYPOTENSION WAS SECONDARY TO A VAGAL RESPONSE AND LATER DISCOVERED THE EFFUSION. LOCATION AND CAUSE OF THE PERICARDIAL EFFUSION HAS NOT BEEN ESTABLISHED. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. SHEATH USED WAS A ST. JUDE MEDICAL SR0. GENERATOR WAS S

  Patient problems: Cardiac Tamponade; No Code Available

  MAUDE report 7292603 ↗