SOUNDSTAR 10439072Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10846835008845), received between Oct 28, 2018 and Feb 20, 2026 — classified as 4 deaths, 17 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (15 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2026Patient Device Interaction Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A NON-BWI CATHETER AND SOUNDSTAR CATHETER, THE PATIENT EXPERIENCED BLOOD PRESSURE DROPPED, AND PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS WITH A MODERATE AMOUNT OF BLOOD WITHDRAWN. THE PATIENT WAS STABLE ON TRANSFER TO ICU FOR FURTHER MONITORING. THE PHYSICIAN COMMENTED THAT EITHER THE PFA (PULSE FIELD ABLATION) APPLICATIONS IN THE SVC (SUPERIOR VENA CAVA) OR THE MANIPULATION OF THE SOUNDSTAR CATHETER MOST LIKELY CAUSED THE PERICARDIAL EFFUSION. THE REPORT INDICATED THAT THE PATIENT HAD AN ADVERSE EVENT/PERICARDIAL EFFUSION. POST COMPLETION OF PFA WITH THE BOSTON SCIENTIFIC FARAWAVE CATHETER THE PHYSICIAN ADVANCED THE CATHETER INTO THE SVC, AND SHORTLY AFTER APPLYING PFA TO THE SVC THE ANESTHESIOLOGIST REPORTED THAT THE PATIENT'S BLOOD PRESSURE HAD DROPPED. A PERICARDIAL EFFUSION WAS DISCOVERED USING INTRACARDIAC ECHO. PERICARDIOCENTESIS WAS COMPLETED AND A MODERATE AMOUNT OF BLOOD WAS WITHDRAWN. THE PHYSICIAN COMMENTED THAT EITHER THE PFA APPLICATIONS IN THE SVC OR THE MANIPULATION OF THE SOUNDSTAR CATHETER MOST LIKELY CAUSED THE PERICARDIAL EFFUSION. THE PRODUCTS USED DURING THE PROCEDURE WERE A 10FR GE SOUNDSTAR CAT

  Patient problems: Cardiac Tamponade

  MAUDE report 24408059 ↗
• MalfunctionJan 22, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A SOUNDSTAR CATHETER WITH WHEN THE CATHETER WAS ABOUT TO BE OPENED THE MEDICAL TEAM SAW THAT THE PACKAGING WAS COMPROMISED WITH A CUT IN IT. THEY OPENED ANOTHER CATHETER AND THE CASE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24152482 ↗
• MalfunctionJan 16, 2026Communication or Transmission Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A SOUNDSTAR CATHETER AND THE CATHETER WAS NOT RECOGNIZED BY THE S70 ULTRASOUND SYSTEM WHEN IT WAS CONNECTED TO THE PIU ON THE CARTO 3 SYSTEM. CHANGING OUT THE ULTRASOUND SYSTEM AND THE SWIFTLINK CABLE DID NOT RESOLVE THE ISSUE. CONNECTING A DUMMY CATHETER RESOLVED THE ISSUE. THEY THEN REPLACED THE SOUNDSTAR CATHETER AND THE ISSUE WAS RESOLVED, AND THE PROCEDURE WAS THEN CONTINUED. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND SOUNDSTAR MAGNETIC, RECOGNITION, AND VISUALIZATION TESTING OF THE RETURNED DEVICE WERE PERFORMED. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED TWO CUTS ON THE SHAFT AND INTERNAL COMPONENTS EXPOSED. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24096663 ↗
• MalfunctionJul 28, 2025Device Displays Incorrect Message

  EVENT 1 [DATE REDACTED] LOT: G4173172. DURING PREP OF THE ULTRASOUND CATHETER, THE WAS AN ERROR MESSAGE. THE CATHETER WAS REMOVED AND REPLACED WITH NO HARM TO THE PATIENT. EVENT 2 [DATE REDACTED] LOT: G4175334. THERE WAS A DEFECTIVE CONNECTOR ON THE ULTRASOUND CATHETER. THE CATHETER WAS REMOVED AND REPLACED WITH NO HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR ULTRASOUND CATHETER, 10FR X 90CM SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER (PER SITE REPORTER). MFG [MANUFACTURER] NOTIFIED BY SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22622810 ↗
• InjuryMar 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND THE PATIENT EXPERIENCED PSEUDOANEURYSM THAT REQUIRED SURGICAL INTERVENTION. AFTER AN ATRIAL FIBRILLATION CASE, A PSEUDOANEURYSM WAS NOTICED. THE SCRUB TECH NOTICED THE PATIENT WAS BLEEDING FROM THE ACCESS POINT. THE PHYSICIAN INSPECTED THE ACCESS POINT AND DETERMINED THE INJURY WAS A PSEUDOANEURYSM. THE PATIENT WAS BEING SENT TO SURGERY FOR MEDICAL INTERVENTION. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE MEDICAL TEAM BELIEVED THE INJURY WAS A RESULT OF GETTING INTRACARDIAC ECHO (ICE) CATHETER ACCESS IN THE VEIN. THE PHYSICIAN BELIEVES THEY HIT AN ARTERY INSTEAD OF A VEIN WHILE ATTEMPTING TO GAIN VENOUS ACCESS. PHYSICIAN THINKS IT WAS PATIENT ANATOMY AND NOTHING TO DO WITH BWI PRODUCTS. OTHER RELEVANT MEDICAL HISTORY INCLUDES PREVIOUS GRAFT PLACED THAT MAY HAVE BEEN RUPTURED DURING ACCESS.

  Patient problems: Pseudoaneurysm

  MAUDE report 21502022 ↗
• MalfunctionDec 31, 2024Communication or Transmission Problem; Material Protrusion/Extrusion; Communication or Transmission Problem; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A SOUNDSTAR AND AFTER THE ORDER WAS REVIEWED, THE OUTER BOX AND THE INSIDE CARTON OF THE SOUNDSTAR® CATHETER WERE FOUND BROKEN AND THE CONNECTOR ON THE CATHETER WAS ALSO BROKEN. THE DAMAGE WAS FOUND ON THE PROXIMAL MOST PART OF THE CATHETER AT THE SWIFT LINK CONNECTION. THE REPORTER REQUESTED A REPLACEMENT FOR THE SOUNDSTAR® CATHETER. THE DAMAGE RESULTED IN WIRES/INTERNAL COMPONENTS BEING EXPOSED. THE DAMAGE DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. THE CATHETER WAS NOT USED IN THE PROCEDURE, AS THE DAMAGE WAS EVIDENT WHEN REMOVED FROM PACKAGING. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21049386 ↗
• InjuryDec 6, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER ABLATION WITH A SOUNDSTAR ECO GE 10F CATHETER AND THE PATIENT EXPERIENCED THROMBUS, CARDIAC FAILURE, AND CARDIAC ARREST THAT REQUIRED CPR. IT WAS REPORTED THAT THE PATIENT HAD A "SLUGGISH" EJECTION FRACTION WHEN SOUNDSTAR CATHETER WAS PLACED IN THE PATIENT. THE PATIENT WENT INTO PEA (PULSELESS ELECTRICAL ACTIVITY) SHORTLY AFTER THE CATHETER WAS USED TO VISUALIZE THE HEART. A CODE WAS CALLED AND CPR WAS INITIATED. IT WAS ALSO REPORTED THAT A CLOT WAS VISUALIZED IN THE RIGHT ATRIUM. THE PATIENT WAS STABLE AND NO FURTHER INTERVENTION WAS PLANNED. PATIENT WAS TRANSFERRED TO ICU. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS PATIENT CONDITION. NO ABLATION CATHETER WAS OPENED AND NO ABLATION WAS DONE. THE SOUNDSTAR WAS IN THE PATIENT. NO TRANSSEPTAL PUNCTURE WAS DONE AND IT WAS STILL RIGHT SIDED. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE.

  Patient problems: Cardiac Arrest; Heart Failure/Congestive Heart Failure; Thrombosis/Thrombus

  MAUDE report 20861402 ↗
• MalfunctionMay 7, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR® ECO DIAGNOSTIC. ULTRASOUND CATHETER AND A FOREIGN MATERIAL WAS ENCOUNTERED. IT WAS REPORTED THAT IT WAS DISCOVERED AFTER THE CATHETER WAS REMOVED FROM THE PACKAGING THAT THE CATHETER WAS COVERED IN A WHITE FLAKY SUBSTANCE. THE CALLER STATED THAT THE WHITE FLAKY SUBSTANCE WAS DISCOVERED ON THE SHAFT, CONNECTOR, AND HANDLE OF THE CATHETER. THEY REPLACED THE CATHETER WITH AN ACUNAV CATHETER AND THE PROCEDURE CONTINUED WITHOUT FURTHER ISSUES. THERE WAS NO PATIENT CONSEQUENCE AS IT WAS NOT PLACED IN BODY DUE TO SUBSTANCE ON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883726 ↗
• MalfunctionApr 20, 2023Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem; Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND A FOREIGN MATERIAL WAS ENCOUNTERED. IT WAS REPORTED THAT IT WAS DISCOVERED AFTER THE CATHETER WAS REMOVED FROM THE PACKAGING THAT THE CATHETER WAS COVERED IN A WHITE FLAKY SUBSTANCE. THE CALLER STATED THAT THE WHITE FLAKY SUBSTANCE WAS DISCOVERED ON THE SHAFT, CONNECTOR, AND HANDLE OF THE CATHETER. THEY REPLACED THE CATHETER WITH AN ACUNAV CATHETER AND THE PROCEDURE CONTINUED WITHOUT FURTHER ISSUES. THERE WAS NO PATIENT CONSEQUENCE AS IT WAS NOT PLACED IN BODY DUE TO SUBSTANCE ON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16777859 ↗
• InjuryApr 13, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER LEFT (L-AFL) ABLATION PROCEDURE WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND SUFFERED A CARDIAC TAMPONADE (CT) REQUIRING PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT DURING "2 HOURS POST-OP" FROM THIS CASE, IT WAS DISCOVERED WITH A "TTE POST-ABLATION ECHO" WHILE IN RECOVERY, THAT THE PATIENT HAD SUFFERED A PERICARDIAL EFFUSION (PE). THE PATIENT'S EFFUSION WAS THEN "TAPPED AND DRAINED" AND 500 CC OF FLUID WAS REMOVED FROM THE PATIENT. THE PATIENT WAS REPORTED AS STABLE AND DID NOT NEED SURGERY. THIS WAS NOT A PART OF ANY STUDY. THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE STATED THAT THEY USED A 10 FR SOUNDSTAR CATHETER, A SMART TOUCH SF (STSF) ABLATION CATHETER, A VIZIGO SHEATH, AND A PENTARAY IN THE CASE. HOWEVER, NONE OF THE DEVICES ARE AVAILABLE FOR RETURN DUE TO THE INJURY BEING DISCOVERED "2 HOURS POST-OP". THE PHYSICIAN DID NOT STATE WHAT THEY BELIEVE THE SOURCE OF THE INJURY TO BE. IT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS PROCEDURE RELATED. OUTCOME OF THE ADVERSE EVENT WAS IMPROVED. THE P

  Patient problems: Cardiac Tamponade

  MAUDE report 16734075 ↗
• InjuryApr 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER LEFT (L-AFL) ABLATION PROCEDURE WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND SUFFERED A CARDIAC TAMPONADE (CT) REQUIRING PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT DURING "2 HOURS POST-OP" FROM THIS CASE, IT WAS DISCOVERED WITH A ¿TTE POST-ABLATION ECHO" WHILE IN RECOVERY, THAT THE PATIENT HAD SUFFERED A PERICARDIAL EFFUSION (PE). THE PATIENT'S EFFUSION WAS THEN "TAPPED AND DRAINED" AND 500 CC OF FLUID WAS REMOVED FROM THE PATIENT. THE PATIENT WAS REPORTED AS STABLE AND DID NOT NEED SURGERY. THIS WAS NOT A PART OF ANY STUDY. THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE STATED THAT THEY USED A 10 FR SOUNDSTAR CATHETER, A SMART TOUCH SF (STSF) ABLATION CATHETER, A VIZIGO SHEATH, AND A PENTARAY IN THE CASE. HOWEVER, NONE OF THE DEVICES ARE AVAILABLE FOR RETURN DUE TO THE INJURY BEING DISCOVERED "2 HOURS POST-OP". THE PHYSICIAN DID NOT STATE WHAT THEY BELIEVE THE SOURCE OF THE INJURY TO BE. IT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS PROCEDURE RELATED. OUTCOME OF THE ADVERSE EVENT WAS IMPROVED. THE P

  Patient problems: Cardiac Tamponade

  MAUDE report 16710197 ↗
• InjuryMar 28, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RE-DO AFIB CARDIAC ABLATION PROCEDURE WITH THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL CATHETER AND SOUNDSTAR ECO GE 10F CATHETER. THE PATIENT EXPERIENCED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT A PERFORATION AND CARDIAC TAMPONADE OCCURRED DURING A REDO AFIB PROCEDURE. THEY REPORTED THAT AFTER PERFORMING 2 ABLATIONS, THE PATIENT'S BLOOD PRESSURE DROPPED. THE PERICARDIAL EFFUSION WAS CONFIRMED WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 750 ML OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. IT WAS SUSPECTED THAT THE ICE CATHETER OR THE WEBSTER CORONARY SINUS (CS) CATHETER CAUSED THE PERFORATION BUT THAT THEY WERE UNSURE. ADDITIONAL INFORMATION: OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. RELEVANT TESTS/LABORATORY DATA- NONE. OTHER RELEVANT HISTORY-50% EJECTION FRACTION, HISTORY OF A FIB. GENERATOR INFORMATION WAS A STOCKERT SMART ABLATE:G4C-5466-A. OTHER INFORMATION: PATIENT WAS 6 FOOT 2 INCHES. 750 ML OF BLOOD WAS REMOVED. BLOOD TRANSFUSION THROUGH IV WAS PERFORMED. HEP

  Patient problems: Cardiac Tamponade

  MAUDE report 16625683 ↗
• InjuryMar 17, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RE-DO AFIB CARDIAC ABLATION PROCEDURE WITH THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL CATHETER AND SOUNDSTAR ECO GE 10F CATHETER. THE PATIENT EXPERIENCED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT A PERFORATION AND CARDIAC TAMPONADE OCCURRED DURING A REDO AFIB PROCEDURE. THEY REPORTED THAT AFTER PERFORMING 2 ABLATIONS, THE PATIENT'S BLOOD PRESSURE DROPPED. THE PERICARDIAL EFFUSION WAS CONFIRMED WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 750 ML OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. IT WAS SUSPECTED THAT THE ICE CATHETER OR THE WEBSTER CORONARY SINUS (CS) CATHETER CAUSED THE PERFORATION BUT THAT THEY WERE UNSURE. ADDITIONAL INFORMATION: OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. RELEVANT TESTS/LABORATORY DATA- NONE. OTHER RELEVANT HISTORY-50% EJECTION FRACTION, HISTORY OF A FIB. GENERATOR INFORMATION WAS A STOCKERT SMART ABLATE: G4C-5466-A. OTHER INFORMATION: PATIENT WAS 6 FOOT 2 INCHES. 750 ML OF BLOOD WAS REMOVED. BLOOD TRANSFUSION THROUGH IV WAS PERFORMED. HE

  Patient problems: Cardiac Tamponade

  MAUDE report 16563286 ↗
• InjuryJan 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND THE PATIENT SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT DURING A PVC ABLATION CASE, PERICARDIAL EFFUSION WAS NOTICED. THE CALLER REPORTED THERE WERE NO VISIBLE SIGNS ON THE PATIENT. THE PERICARDIAL EFFUSION WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE CALLER REPORTED THAT THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 150ML OF FLUID WAS REMOVED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS, DURING THE MAPPING PHASE. NO ABLATION WAS PERFORMED, AS SUCH, THERE WAS NO STEAM POP. THE PHYSICIANS OPINION IS THAT HE PERFORATED WITH ICE CATHETER. THERE WAS NO MALFUNCTION OF EQUIPMENT. THE PATIENT'S OUTCOME FROM THE ADVERSE EVENT IS THAT IT WAS IMPROVED. IT IS UNCERTAIN IF THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT, THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU) FOR OBSERVATION. A SMARTABLATE GENERATOR WAS USED DURING THIS

  Patient problems: Cardiac Tamponade

  MAUDE report 16222523 ↗
• InjuryJan 17, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND THE PATIENT SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT DURING A PVC ABLATION CASE, PERICARDIAL EFFUSION WAS NOTICED. THE CALLER REPORTED THERE WERE NO VISIBLE SIGNS ON THE PATIENT. THE PERICARDIAL EFFUSION WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE CALLER REPORTED THAT THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 150ML OF FLUID WAS REMOVED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS, DURING THE MAPPING PHASE. NO ABLATION WAS PERFORMED, AS SUCH, THERE WAS NO STEAM POP. THE PHYSICIANS OPINION IS THAT HE PERFORATED WITH ICE CATHETER. THERE WAS NO MALFUNCTION OF EQUIPMENT. THE PATIENT¿S OUTCOME FROM THE ADVERSE EVENT IS THAT IT WAS IMPROVED. IT IS UNCERTAIN IF THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT, THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU) FOR OBSERVATION. A SMARTABLATE GENERATOR WAS USED DURING THIS

  Patient problems: Cardiac Tamponade

  MAUDE report 16190819 ↗
• InjuryFeb 7, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A FEMALE PATIENT BORN (B)(6) UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER. THE PATIENT SUFFERED CARDIAC PERFORATION REQUIRING PERICARDIOCENTESIS. DURING AN IDIOPATHIC VT CASE, AN ATRIAL CARDIAC PERFORATION AND PERICARDIAL EFFUSION WERE NOTICED IN THE PATIENT. AFTER USING A NON-BWI SLO SHEATH TO GO TRANSSEPTAL, THE SLO SHEATH WAS REPLACED WITH AN AGILIS SHEATH, AND WHEN GOING INTO THE RV IN ORDER TO DO CONTOURS IN THE VENTRICLES, THE PERICARDIAL EFFUSION WAS NOTICED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WITH THE SOUNDSTAR CATHETER. NO ABLATION CATHETER HAD BEEN INSIDE THE PATIENT AT THIS POINT IN THE PROCEDURE, ONLY A SOUNDSTAR CATHETER. THE PERICARDIAL EFFUSION AND CARDIAC PERFORATION WERE CONFIRMED VIA ICE AND THE FLUOROSCOPY SYSTEM. THE MEDICAL INTERVENTION PROVIDED TO THE PATIENT WAS A PERICARDIOCENTESIS, AND ABOUT 770CC OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT: PROCEDURE: PHYSICIAN BELIEVES THIS OCCURRED DURING TRANSSEPTAL PUNCTURE. PATIENT OUTCOME OF THE ADVERSE EVENT: FULLY RECOVERED

  Patient problems: Cardiac Perforation

  MAUDE report 13475082 ↗
• InjuryFeb 2, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  HOLD FOR EM 4.8 IT WAS REPORTED THAT A FEMALE PATIENT BORN (B)(6) 1948 UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER. THE PATIENT SUFFERED CARDIAC PERFORATION REQUIRING PERICARDIOCENTESIS. DURING AN IDIOPATHIC VT CASE, AN ATRIAL CARDIAC PERFORATION AND PERICARDIAL EFFUSION WERE NOTICED IN THE PATIENT. AFTER USING A NON-BWI SLO SHEATH TO GO TRANSSEPTAL, THE SLO SHEATH WAS REPLACED WITH AN AGILIS SHEATH, AND WHEN GOING INTO THE RV IN ORDER TO DO CONTOURS IN THE VENTRICLES, THE PERICARDIAL EFFUSION WAS NOTICED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WITH THE SOUNDSTAR CATHETER. NO ABLATION CATHETER HAD BEEN INSIDE THE PATIENT AT THIS POINT IN THE PROCEDURE, ONLY A SOUNDSTAR CATHETER. THE PERICARDIAL EFFUSION AND CARDIAC PERFORATION WERE CONFIRMED VIA ICE AND THE FLUOROSCOPY SYSTEM. THE MEDICAL INTERVENTION PROVIDED TO THE PATIENT WAS A PERICARDIOCENTESIS, AND ABOUT 770CC OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT: PROCEDURE: PHYSICIAN BELIEVES THIS OCCURRED DURING TRANSSEPTAL PUNCTURE. PATIENT OUTCOME OF THE ADVERSE E

  Patient problems: Cardiac Perforation

  MAUDE report 13420463 ↗
• InjuryFeb 24, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE AND SUFFERED CARDIAC ARREST REQUIRING CARDIOPULMONARY RESUSCITATION (CPR) AND LEFT HEART CATHETERIZATION. AFTER PERFORMING THE FIRST TRANSSEPTAL PUNCTURE AND WHILE MAPPING THE LEFT ATRIUM (LA) THE PATIENT'S VITAL SIGNS BEGAN TO DROP. THE PHYSICIAN NOTICED A DROP IN BLOOD PRESSURE AND HEART RATE. AN INTERVENTIONAL CARDIOLOGIST WAS PAGED, CPR AND A LEFT HEART CATHETERIZATION WERE PERFORMED. THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER WERE IN THE BODY WHEN THE PATIENT'S VITAL SIGNS STARTED DECLINING AND THE ABLATION CATHETER WAS LATER INTRODUCED TO PACE THE HEART. NO ABLATION HAD BEEN PERFORMED AT THIS POINT. THE CALLER STATED THAT THERE WERE NO FINDINGS (ANOMALIES) FROM THE LEFT HEART CATHETERIZATION. THE PHYSICIAN ALSO USED THE SOUNDSTAR CATHETER TO CONFIRM THERE WAS NO EFFUSION OR PERFORATIONS. THE PATIENT WAS STABILIZED, HIS CONDITION IMPROVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER COMPLICATIONS. PHYSICIAN'S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. NO BWI PRODUCT MALF

  Patient problems: Cardiac Arrest

  MAUDE report 11374380 ↗
• InjuryFeb 24, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER AND SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. AT THE END OF THE PROCEDURE, THE ANESTHESIOLOGIST REPORTED A PATIENT BLOOD PRESSURE DROP WHICH WAS UNRESPONSIVE TO THEIR TREATMENT. AN ECHOCARDIOGRAM WITH THE INTRACARDIAC ECHO CATHETER REVEALED A 2-3CM EFFUSION AROUND THE RIGHT VENTRICLE (RV). A PERICARDIOCENTESIS WAS PERFORMED REMOVING 650 ML OF BLOOD FROM AROUND THE HEART, IT WAS RETURNED TO THE PATIENT SIMULTANEOUSLY. PROLONGED HOSPITALIZATION WAS REQUIRED. PATIENT HAD FULLY RECOVERED FROM THE EVENT. SINCE THE NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER WAS USED FOR MAPPING AND ABLATING, THE PHYSICIAN THOUGHT IT UNLIKELY FOR THIS CATHETER TO HAVE CAUSED THE PERFORATION AND SUBSEQUENT EFFUSION. THE PHYSICIAN BELIEVED THE SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER PERFORATED THE RV APEX CONTRIBUTING TO THE EVENT. NO BIOSENSE WEBSTER, INC. PRODUCT MALFUNCTIONS WERE REQUIRED. TRANSSEPTAL PUNCTURE WAS DONE WITH A BAYLIS NEEDLE, 98 CM LARGE CURVE. THE

  Patient problems: Cardiac Tamponade

  MAUDE report 11374314 ↗
• DeathFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD MALE PATIENT ((B)(6) LBS) UNDERWENT A CARDIAC ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND SUFFERED VENTRICULAR FIBRILLATION (VFIB), MYOCARDIAL INFARCTION, AND DEATH. WHILE MAPPING IN THE RIGHT ATRIUM (RA), IN PREPARATION FOR ABLATION IN THE LEFT ATRIUM (PRIOR TO TRANSSEPTAL PROCEDURE), THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA, WAS CODED AND THEN EXPIRED. FIRST, A CARTOSOUND MAP WAS CREATED OF THE LEFT ATRIUM WITH THE SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER. A SMART TOUCH SF CATHETER (USED ONLY TO MAP THE RIGHT ATRIUM) WAS PLACED INTO THE CORONARY SINUS (CS) TO CREATE A FAST-ANATOMICAL MAPPING (FAM) MAP. THIS WAS REMOVED THEN THE CORONARY SINUS CATHETER WAS PLACED INTO THE CORONARY SINUS. NO RADIOFREQUENCY WAS DELIVERED AT ANY TIME. AT THIS POINT THE CERTIFIED REGISTERED NURSE ANESTHETISTS (CRNA) STATED TO THE PHYSICIAN THAT "THE PATIENT HAD A LOT OF CO2 CONSUMPTION," AND THAT "IT WOULD BE EASIER TO PARALYZE THE PATIENT." WHEN THE ANESTHESIOLOGIST CAME INTO THE ROOM TO PUT THE PATIENT UNDER GENERAL ANESTHESIA, THEY COMMENTED THAT THE PATIENT'S VITALS WERE "TANKING." TH

  Patient problems: Myocardial Infarction; Ventricular Fibrillation

  MAUDE report 11355733 ↗
• DeathFeb 17, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD MALE PATIENT ((B)(6) LBS) UNDERWENT A CARDIAC ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND SUFFERED VENTRICULAR FIBRILLATION (VFIB), MYOCARDIAL INFARCTION, AND DEATH. WHILE MAPPING IN THE RIGHT ATRIUM (RA), IN PREPARATION FOR ABLATION IN THE LEFT ATRIUM (PRIOR TO TRANSSEPTAL PROCEDURE), THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA, WAS CODED AND THEN EXPIRED. FIRST, A CARTOSOUND MAP WAS CREATED OF THE LEFT ATRIUM WITH THE SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER. A SMART TOUCH SF CATHETER (USED ONLY TO MAP THE RIGHT ATRIUM) WAS PLACED INTO THE CORONARY SINUS (CS) TO CREATE A FAST-ANATOMICAL MAPPING (FAM) MAP. THIS WAS REMOVED THEN THE CORONARY SINUS CATHETER WAS PLACED INTO THE CORONARY SINUS. NO RADIOFREQUENCY WAS DELIVERED AT ANY TIME. AT THIS POINT THE CERTIFIED REGISTERED NURSE ANESTHETISTS (CRNA) STATED TO THE PHYSICIAN THAT "THE PATIENT HAD A LOT OF CO2 CONSUMPTION," AND THAT "IT WOULD BE EASIER TO PARALYZE THE PATIENT." WHEN THE ANESTHESIOLOGIST CAME INTO THE ROOM TO PUT THE PATIENT UNDER GENERAL ANESTHESIA, THEY COMMENTED THAT THE PATIENT'S VITALS WERE "TANKING." T

  Patient problems: Myocardial Infarction; Ventricular Fibrillation

  MAUDE report 11340284 ↗
• InjuryFeb 17, 2021Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE AND SUFFERED CARDIAC ARREST REQUIRING CARDIOPULMONARY RESUSCITATION (CPR) AND LEFT HEART CATHETERIZATION. AFTER PERFORMING THE FIRST TRANSSEPTAL PUNCTURE AND WHILE MAPPING THE LEFT ATRIUM (LA) THE PATIENT'S VITAL SIGNS BEGAN TO DROP. THE PHYSICIAN NOTICED A DROP IN BLOOD PRESSURE AND HEART RATE. AN INTERVENTIONAL CARDIOLOGIST WAS PAGED, CPR AND A LEFT HEART CATHETERIZATION WERE PERFORMED. THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER WERE IN THE BODY WHEN THE PATIENT'S VITAL SIGNS STARTED DECLINING AND THE ABLATION CATHETER WAS LATER INTRODUCED TO PACE THE HEART. NO ABLATION HAD BEEN PERFORMED AT THIS POINT. THE CALLER STATED THAT THERE WERE NO FINDINGS (ANOMALIES) FROM THE LEFT HEART CATHETERIZATION. THE PHYSICIAN ALSO USED THE SOUNDSTAR CATHETER TO CONFIRM THERE WAS NO EFFUSION OR PERFORATIONS. THE PATIENT WAS STABILIZED, HIS CONDITION IMPROVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER COMPLICATIONS. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. NO BWI PRODUCT MALF

  Patient problems: Cardiac Arrest

  MAUDE report 11339977 ↗
• InjuryFeb 17, 2021Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER AND SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. AT THE END OF THE PROCEDURE, THE ANESTHESIOLOGIST REPORTED A PATIENT BLOOD PRESSURE DROP WHICH WAS UNRESPONSIVE TO THEIR TREATMENT. AN ECHOCARDIOGRAM WITH THE INTRACARDIAC ECHO CATHETER REVEALED A 2-3CM EFFUSION AROUND THE RIGHT VENTRICLE (RV). A PERICARDIOCENTESIS WAS PERFORMED REMOVING 650 ML OF BLOOD FROM AROUND THE HEART, IT WAS RETURNED TO THE PATIENT SIMULTANEOUSLY. PROLONGED HOSPITALIZATION WAS REQUIRED. PATIENT HAD FULLY RECOVERED FROM THE EVENT. SINCE THE NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER WAS USED FOR MAPPING AND ABLATING, THE PHYSICIAN THOUGHT IT UNLIKELY FOR THIS CATHETER TO HAVE CAUSED THE PERFORATION AND SUBSEQUENT EFFUSION. THE PHYSICIAN BELIEVED THE SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER PERFORATED THE RV APEX CONTRIBUTING TO THE EVENT. NO BIOSENSE WEBSTER, INC. PRODUCT MALFUNCTIONS WERE REQUIRED. TRANSSEPTAL PUNCTURE WAS DONE WITH A BAYLIS NEEDLE, 98 CM LARGE CURVE. THE

  Patient problems: Cardiac Tamponade

  MAUDE report 11339709 ↗
• DeathFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD MALE PATIENT UNDERWENT A RIGHT SIDED ATRIAL FLUTTER (R-AFL) ABLATION PROCEDURE WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND A WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID AND SUFFERED CARDIAC ARREST (REQUIRING CARDIOPULMONARY RESUSCITATION (CPR)) AND RESULTED IN DEATH. WHEN THE DIAGNOSTIC PORTION OF THE PROCEDURE WAS COMPLETED (WHILE USING DIAGNOSTIC CATHETERS ONLY), THE PATIENT'S BLOOD PRESSURE DROPPED DRASTICALLY. THE SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER WAS STILL INSIDE THE PATIENT'S BODY AND WAS USED TO CHECK FOR AN EFFUSION; HOWEVER, NO EFFUSION WAS CONFIRMED. THE ECHO TEAM WAS CALLED TO THE ROOM TO FURTHER EVALUATE THE POTENTIAL CAUSE OF THE DROP IN THE PATIENT'S BLOOD PRESSURE. THE PATIENT THEN WENT INTO CARDIAC ARREST. CODE WAS CALLED OVER HOSPITAL INTERCOM, AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. AFTER APPROXIMATELY ONE HOUR, IT WAS ANNOUNCED THAT THE PATIENT HAD EXPIRED. THE PHYSICIAN'S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PATIENT CONDITION RELATED, SINCE THE PATIENT WAS AN INPATIENT THAT HAD BEEN EXPERIENCING FLUTTER FOR AN EXTENDED PERIOD ALONG WITH OTHER

  Patient problems: Cardiac Arrest; Death

  MAUDE report 9758408 ↗
• DeathFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD MALE PATIENT UNDERWENT A RIGHT SIDED ATRIAL FLUTTER (R-AFL) ABLATION PROCEDURE WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND A WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID AND SUFFERED CARDIAC ARREST (REQUIRING CARDIOPULMONARY RESUSCITATION (CPR)) AND RESULTED IN DEATH. WHEN THE DIAGNOSTIC PORTION OF THE PROCEDURE WAS COMPLETED (WHILE USING DIAGNOSTIC CATHETERS ONLY), THE PATIENT¿S BLOOD PRESSURE DROPPED DRASTICALLY. THE SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER WAS STILL INSIDE THE PATIENT¿S BODY AND WAS USED TO CHECK FOR AN EFFUSION; HOWEVER, NO EFFUSION WAS CONFIRMED. THE ECHO TEAM WAS CALLED TO THE ROOM TO FURTHER EVALUATE THE POTENTIAL CAUSE OF THE DROP IN THE PATIENT¿S BLOOD PRESSURE. THE PATIENT THEN WENT INTO CARDIAC ARREST. CODE WAS CALLED OVER HOSPITAL INTERCOM, AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. AFTER APPROXIMATELY ONE HOUR, IT WAS ANNOUNCED THAT THE PATIENT HAD EXPIRED. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PATIENT CONDITION RELATED, SINCE THE PATIENT WAS AN INPATIENT THAT HAD BEEN EXPERIENCING FLUTTER FOR AN EXTENDED PERIOD ALONG WITH OTHER

  Patient problems: Cardiac Arrest; Death

  MAUDE report 9741577 ↗