SOUNDSTAR 10438577Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10846835008838), received between Nov 5, 2019 and May 1, 2025 — classified as 1 death, 12 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (8 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A SOUNDSTAR CATHETER AND THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION TREATED WITH A PERICARDIOCENTESIS, FOLLOWED BY SURGERY THAT FOUND A CARDIAC PERFORATION, AND HOSPITAL ADMISSION FOR FURTHER EVALUATION. SOMETIME DURING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE BUT TREATED BY MEDICATIONS FROM THE ANESTHESIA TEAM. AFTER COMPLETING PULSE FIELD ABLATION (PFA), THE PHYSICIAN USED THE SOUNDSTAR CATHETER TO EVALUATE THE PERICARDIAL SPACE. THE PHYSICIAN NOTICED A PERICARDIAL EFFUSION. THE PATIENT UNDERWENT A PERICARDIOCENTESIS PROCEDURE, REMOVAL OF 900MLS OF FLUID REMOVED FROM THE PATIENT'S PERICARDIAL SPACE. THEN, THE PATIENT TRANSPORTED TO SURGERY. THE SURGEON INFORMED THEM THAT A PERFORATION WAS SEEN WITHIN THE PATIENT'S LEFT ATRIAL APPENDAGE. AFTER SURGERY, THE PATIENT IS CURRENTLY STABLE. THE PATIENT WAS ADMITTED FOR FURTHER EVALUATION. THE PHYSICIAN BELIEVES THAT THE SOUNDSTAR CATHETER MIGHT HAVE CAUSED THE PERFORATION. ADDITIONAL INFORMATION WAS RECEIVED ON 21-APR-2025 WHICH INDICATED THAT THE PHYSICIAN BELIEVES THE SOUNDSTAR CATHETER MAY HAVE BEEN THE DEVICE THAT CAUSED THE PERFORATION TO

  Patient problems: Cardiac Perforation

  MAUDE report 21940808 ↗
• MalfunctionMar 13, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR AND AFTER THE CATHETER WAS DEFLECTED AND LOCKED INTO POSITION, THE CATHETER WOULD NOT UNLOCK. IT WAS REMOVED WITHOUT INCIDENT, AND IT WAS REPLACED. THE CASE WAS CONTINUED WITHOUT FURTHER INCIDENCE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21601432 ↗
• MalfunctionNov 6, 2024Mechanical Jam; Positioning Problem; Mechanical Jam; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) PROCEDURE WITH A SOUNDSTAR CATHETER AND OBSERVED THE CURVE GETTING STUCK. THE DEFLECTION OF THE SOUNDSTAR CATHETER WAS NOT ADEQUATE. THE CURVE WAS GETTING STUCK EVEN THOUGH THE CATHETER WAS UNLOCKED ON FLUOROSCOPY. THE CATHETER HAD TO BE MANUALLY UNCURVED. THE REFLECTION KNOBS WERE GETTING STUCK. THE PROCEDURE WAS CONTINUED WITH THE ISSUE STILL PRESENT. NO PATIENT CONSEQUENCE WAS REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622003 ↗
• MalfunctionNov 5, 2024Mechanical Jam; Positioning Problem; Mechanical Jam; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A SOUNDSTAR ECO SMS 10F CATHETER AND IT WOULD NOT CURVE WHEN BEING DIRECTED TO. WHEN THE MEDICAL TEAM WOULD ATTEMPT TO CURVE THE CATHETER, IT WOULD LOCK. THE KNOB/PISTON WAS ABLE TO MOVE STILL. HOWEVER, THE TEAM HAD TO MANUALLY UN-DEFLECT THE CATHETER. THERE WERE NO ERROR CODES. THERE WAS NO DIFFICULTY IN REMOVING THE CATHETER EITHER. THE PROCEDURE WAS CONTINUED WITH THE ISSUE STILL PRESENT. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20615043 ↗
• MalfunctionOct 30, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A SOUNDSTAR ECO SMS 10F CATHETER AND AFTER THE PHYSICIAN ACTIVATED THE DEFLECTION IT WOULD NOT GO BACK TO NEUTRAL. THE CATHETER WAS REMOVED FROM THE BODY BUT REMAINED IN THE DEFLECTED POSITION. THE KNOBS WERE IN NEUTRAL AND IT WAS NOT LOCKED. THERE WAS NO DIFFICULTY IN REMOVING THE CATHETER; HOWEVER, THE MEDICAL TEAM FOUND THE TURNING OF THE KNOBS TO BE STIFF. THE CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20571283 ↗
• DeathDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WHICH INCLUDED THE USE OF A SOUNDSTAR 3D DIAGNOSTIC ULTRASOUND CATHETER, 10F EXPERIENCED CARDIAC ARREST AND DIED. WHEN THE ICE (INTRACARDIAC ECHOCARDIOGRAPHY) CATHETER WAS INSERTED INTO THE PATIENT AT THE BEGINNING OF THE PROCEDURE AND JUST AFTER ACCESS WAS GAINED, IT WAS NOTICED BY ICE THAT THERE WAS NO CARDIAC MOVEMENT. THE ICE CATHETER WAS THE ONLY BWI CATHETER INSIDE OF THE PATIENT. RESUSCITATION EFFORTS WITH CPR AND DRUG ADMINISTRATION WERE PROVIDED. THE PATIENT HAD A TRACH PRIOR TO THE PROCEDURE AND THE PHYSICIAN BELIEVED THE DEATH MAY HAVE OCCURRED DUE TO HYPOXIA. THE CAUSE OF DEATH IS UNKNOWN DUE TO LIMITED INFORMATION. AS THE ULTRASOUND CATHETER WAS THE ONLY CATHETER INSIDE THE PATIENT'S BODY AT THE TIME OF THE CARDIA ARREST, IT CANNOT BE COMPLETELY DISSOCIATED AS A CONTRIBUTOR TO THE EVENT.

  Patient problems: Cardiac Arrest

  MAUDE report 18276073 ↗
• InjurySep 25, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE THAT INCLUDED A SOUNDSTAR CATHETER. THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. AT BASELINE, THERE WAS NOTHING NOTICED IN THE PATIENT. RIGHT AFTER THE SOUNDSTAR CATHETER WAS IN THE BODY TRACING CARTOSOUND CONTOURS, THE PATIENT STARTED MOVING. THE PHYSICIAN HAD THE PATIENT INTUBATED. RIGHT BEFORE GOING TRANSSEPTAL, THE PHYSICIAN CHECKED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE), AND NOTICED A LARGE PERICARDIAL EFFUSION PRESENT. THE PERICARDIAL EFFUSION WAS ALSO CONFIRMED ON ICE. THE MEDICAL INTERVENTION PROVIDED TO THE PATIENT WAS A PERICARDIOCENTESIS. ABOUT 190ML OF FLUID WAS REMOVED FROM THE PATIENT, DURING THE PERICARDIOCENTESIS. THE PATIENT WAS ADMITTED TO THE CRITICAL CARE UNIT (CCU) AND IS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 05-SEP-2023. NO ABLATION OCCURRED. NO RF CATHETER WAS USED IN THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 11-SEP-2023. DISCOVERED DURING THE USE OF ICE FOR BASELINE IMAGES. PERICARDIOCENTESIS PERFORMED IN LAB. PATIENT RECOVERED IN CCU AFTER 1 DAY EXTENDED STAY. PER THE PHYSICIAN, THE PATIENT FULLY

  Patient problems: Cardiac Tamponade

  MAUDE report 17812454 ↗
• InjurySep 17, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE THAT INCLUDED A SOUNDSTAR CATHETER. THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. AT BASELINE, THERE WAS NOTHING NOTICED IN THE PATIENT. RIGHT AFTER THE SOUNDSTAR CATHETER WAS IN THE BODY TRACING CARTOSOUND CONTOURS, THE PATIENT STARTED MOVING. THE PHYSICIAN HAD THE PATIENT INTUBATED. RIGHT BEFORE GOING TRANSSEPTAL, THE PHYSICIAN CHECKED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE), AND NOTICED A LARGE PERICARDIAL EFFUSION PRESENT. THE PERICARDIAL EFFUSION WAS ALSO CONFIRMED ON ICE. THE MEDICAL INTERVENTION PROVIDED TO THE PATIENT WAS A PERICARDIOCENTESIS. ABOUT 190ML OF FLUID WAS REMOVED FROM THE PATIENT, DURING THE PERICARDIOCENTESIS. THE PATIENT WAS ADMITTED TO THE CRITICAL CARE UNIT (CCU) AND IS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 05-SEP-2023. NO ABLATION OCCURRED. NO RF CATHETER WAS USED IN THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 11-SEP-2023. DISCOVERED DURING THE USE OF ICE FOR BASELINE IMAGES. PERICARDIOCENTESIS PERFORMED IN LAB. PATIENT RECOVERED IN CCU AFTER 1 DAY EXTENDED STAY. PER THE PHYSICIAN, THE PATIENT FULLY

  Patient problems: Cardiac Tamponade

  MAUDE report 17762425 ↗
• InjuryOct 10, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 80-YEAR-OLD MALE PATIENT (108KG) UNDERWENT A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND THE PATIENT SUFFERED AIR EMBOLISM, THROMBOSIS, ELECTROCARDIOGRAM ST SEGMENT ELEVATION REQUIRING SURGICAL INTERVENTION. DURING A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE, A POSSIBLE BLOOD CLOT OR AIR EMBOLISM WAS DISCOVERED TO HAVE DEVELOPED IN THE RCA (RIGHT CORONARY ARTERY). CALLER STATED THEY FIRST NOTICED ST ELEVATIONS IN THE EKG. TO CONFIRM A BLOOD CLOT OR AIR WAS IN THE RCA, THEY SHOT CONTRAST INTO THE ARTERY AND FOUND THAT IT DID HAVE SLUGGISH FLOW. THEY PUT A CORONARY WIRE DOWN THE RCA AND THE ISSUE RESOLVED. FLOW WAS RESTORED BACK TO THE RCA. THE PATIENT IS STABLE AND THE PROCEDURE WAS CONTINUED. THIS WAS NOT A CARDIAC ABLATION PROCEDURE. THE ONLY BWI PRODUCT IN THE BODY AT THE TIME WAS THE SOUNDSTAR CATHETER. THE PHYSICIAN BELIEVES DILATING THE SEPTUM WITH THE 14 FR ABBOT SHEATH MAY HAVE CAUSED THE ISSUE OR PUTTING THE ICE CATHETER ACROSS INTO THE LEFT ATRIUM COULD HAVE POTENTIALLY ADDED A CLOT OR AIR INTO THE LEFT ATRIUM. THEY THINK THEN THE AIR OR CLOT TRAVELED OUT OF THE LEFT ATRIUM INTO THE LEFT VENTRICLE AN

  Patient problems: Air Embolism; Ischemic Heart Disease; Thrombosis/Thrombus

  MAUDE report 15568584 ↗
• InjuryJan 12, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT BORN ON (B)(6), ((B)(6)KG) UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER. THE PATIENT SUFFERED A VASCULAR PERFORATION. DURING AN AFIB CASE, A PERFORATION OF THE LEFT FEMORAL WAS DISCOVERED BY FLOURO AND CONTRAST. THE PATIENT'S BLOOD PRESSURE WAS STABLE AND WAS UNDER OBSERVATION FOR ABOUT 20 MINUTES AND NO MEDICAL INTERVENTION IN THE CURRENT MOMENT WAS PROVIDED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN BELIEVES THAT WHEN ADVANCING/ENFORCING OF THE INTRA-CARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER MIGHT HAVE CAUSED THE PERFORATION. THE DECANAV WAS USED AFTER THE ICE CATHETER. IT WAS ALSO REPORTED ONE OF THE CURRENT CABLE GOT STUCK IN A PORT ON THE BEEN AND WHEN THE PATIENT GOT TRANSFERRED THE GREEN PATCH CABLE GOT TORN. THE ADVERSE EVENT WAS DISCOVERED DURING THE USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN PUSHED TOO HARD IN THE FEMORAL VEIN WITH THE ULTRASOUND CATHETER WITHOUT UNDERSTANDING THE VENOUS ANATOMY AND PERFORATED. HE DOES NOT THINK IT WAS A PRODUCT MALFUNCTION, SIMPLY JUST FORCED A CATHETER WITHOUT CHECKING. THE PATIENT OUTCOME OF THE ADVERSE EVEN

  Patient problems: Ventricular Fibrillation

  MAUDE report 13237965 ↗
• InjuryJan 6, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT BORN ON (B)(6) ((B)(6) KG) UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER. THE PATIENT SUFFERED A VASCULAR PERFORATION. DURING AN AFIB CASE, A PERFORATION OF THE LEFT FEMORAL WAS DISCOVERED BY FLOURO AND CONTRAST. THE PATIENT'S BLOOD PRESSURE WAS STABLE AND WAS UNDER OBSERVATION FOR ABOUT 20 MINUTES AND NO MEDICAL INTERVENTION IN THE CURRENT MOMENT WAS PROVIDED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN BELIEVES THAT WHEN ADVANCING / ENFORCING OF THE INTRA-CARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER MIGHT HAVE CAUSED THE PERFORATION. THE DECANAV WAS USED AFTER THE ICE CATHETER. IT WAS ALSO REPORTED ONE OF THE CURRENT CABLE GOT STUCK IN A PORT ON THE BEEN AND WHEN THE PATIENT GOT TRANSFERRED THE GREEN PATCH CABLE GOT TORN. THE ADVERSE EVENT WAS DISCOVERED DURING THE USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN PUSHED TOO HARD IN THE FEMORAL VEIN WITH THE ULTRASOUND CATHETER WITHOUT UNDERSTANDING THE VENOUS ANATOMY AND PERFORATED. HE DOES NOT THINK IT WAS A PRODUCT MALFUNCTION, SIMPLY JUST FORCED A CATHETER WITHOUT CHECKING. THE PATIENT OUTCOME OF THE ADVERSE EV

  Patient problems: Perforation of Vessels

  MAUDE report 13173872 ↗
• MalfunctionOct 14, 2021Display or Visual Feedback Problem; Device Displays Incorrect Message

  UNABLE TO OBTAIN DESIRED VIEWS WHEN INSERTED INTO THE PATIENT'S BODY, ERROR MESSAGE READ ON CARTO WORKSTATION. NO HARM TO PATIENT. NEW DEVICE UTILIZED WITHOUT ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12631294 ↗
• MalfunctionMay 25, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER WAS RECEIVED AND IT WAS OBSERVED THAT THERE WAS AN OPEN POUCH SEAL ISSUE. THE SHIPPING BOX FOR THE SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER ARRIVED DAMAGED. THE OUTSIDE SHIPPING BOX APPEARED TO HAVE BEEN STUCK ON SOME KIND OF CONVEYOR BELT, AS THERE WAS A HOLE BURNED THROUGH THE SHIPPING BOX, STRAIGHT THROUGH TO THE CATHETER BOX, AND THE CATHETER HANDLE WAS EXPOSED. IT WAS REPORTED THAT THEY COULD STICK THEIR FINGER THROUGH THE HOLE ON THE SHIPPING BOX, AND PHYSICALLY TOUCH THE CATHETER HANDLE, CONFIRMING THE STERILITY WAS COMPROMISED. THERE WAS NO PATIENT INVOLVEMENT. PER MANUFACTURER BWI, THE PACKAGING DAMAGED ISSUE WAS ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. THE ISSUE WITH THE CATHETER BOX THAT COMPROMISED THE STERILITY OF THE PRODUCT WAS ASSESSED AS A MDR REPORTABLE OPEN POUCH SEAL ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11882244 ↗
• MalfunctionMay 20, 2021Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER WAS RECEIVED AND IT WAS OBSERVED THAT THERE WAS AN OPEN POUCH SEAL ISSUE. THE SHIPPING BOX FOR THE SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER ARRIVED DAMAGED. THE OUTSIDE SHIPPING BOX APPEARED TO HAVE BEEN STUCK ON SOME KIND OF CONVEYOR BELT, AS THERE WAS A HOLE BURNED THROUGH THE SHIPPING BOX, STRAIGHT THROUGH TO THE CATHETER BOX, AND THE CATHETER HANDLE WAS EXPOSED. IT WAS REPORTED THAT THEY COULD STICK THEIR FINGER THROUGH THE HOLE ON THE SHIPPING BOX, AND PHYSICALLY TOUCH THE CATHETER HANDLE, CONFIRMING THE STERILITY WAS COMPROMISED. THERE WAS NO PATIENT INVOLVEMENT. THE PACKAGING DAMAGED ISSUE WAS ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. THE ISSUE WITH THE CATHETER BOX THAT COMPROMISED THE STERILITY OF THE PRODUCT WAS ASSESSED AS A MDR REPORTABLE OPEN POUCH SEAL ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11853605 ↗
• InjuryMar 25, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRYO ATRIAL FIBRILLATION CARDIAC ABLATION PROCEDURE WITH A SOUNDSTAR AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. A PERICARDIAL EFFUSION WAS NOTICED AFTER THEY WENT TRANSSEPTAL. THERE WERE NO VISIBLE SIGNS ON THE PATIENT. THE PERICARDIAL EFFUSION WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND ABOUT 400ML OF FLUID WAS REMOVED. NO ABLATION CATHETERS WERE IN THE BODY AND THE ONLY BIOSENSE WEBSTER, INC. (BWI) CATHETER BEING USED AT THE TIME WAS A SOUNDSTAR CATHETER. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN DID NOT MENTION THE CAUSE OF THE PERICARDIAL EFFUSION.

  Patient problems: Cardiac Tamponade

  MAUDE report 11569672 ↗
• InjuryMar 23, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRYO ATRIAL FIBRILLATION CARDIAC ABLATION PROCEDURE WITH A SOUNDSTAR AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. A PERICARDIAL EFFUSION WAS NOTICED AFTER THEY WENT TRANSSEPTAL. THERE WERE NO VISIBLE SIGNS ON THE PATIENT. THE PERICARDIAL EFFUSION WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND ABOUT 400ML OF FLUID WAS REMOVED. NO ABLATION CATHETERS WERE IN THE BODY AND THE ONLY BIOSENSE WEBSTER, INC. (BWI) CATHETER BEING USED AT THE TIME WAS A SOUNDSTAR CATHETER. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN DID NOT MENTION THE CAUSE OF THE PERICARDIAL EFFUSION. SINCE THIS EVENT (CARDIAC TAMPONADE) IS LIFE THREATENING AND REQUIRED INTERVENTIONS TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, THEN IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE.

  Patient problems: Cardiac Tamponade

  MAUDE report 11555987 ↗
• MalfunctionJan 21, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE FOR ATRIAL FIBRILLATION (AFIB) WITH A SOUNDSTAR CATHETER WHERE A FOREIGN MATERIAL ISSUE OCCURRED. IT WAS REPORTED WHEN THE CATHETER WAS OPENED OUT OF THE BOX THERE WAS FOREIGN MATERIAL DESCRIBED AS ¿AN AMBER CLEAR TAPE¿ AND THE BIOSENSE WEBSTER, INC. REPRESENTATIVE WAS CONCERNED OF ANY ADHESIVE RESIDUE ON THE SOUNDSTAR CATHETER. THE CATHETER CABLE WAS REPLACED AND THE ISSUE REMAINED. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THERE WAS NO REPORT OF PATIENT CONSEQUENCE. THE ORIGIN OF THE FOREIGN MATERIAL WAS UNKNOWN. THE ORIGINAL PACKAGING WAS DISCARDED BY THE ACCOUNT. THE FOREIGN MATERIAL WAS ASSESSED AS A MDR REPORTABLE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11206394 ↗
• InjuryFeb 10, 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 FEMALE PATIENT ((B)(6) KG) UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE FOR SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND SUFFERED VESSEL PERFORATION REQUIRING NO INTERVENTIONS. DURING THE PROCEDURE, WHEN TRYING TO GET ACCESS INTO THE RIGHT FEMORAL VEIN, THEY PERFORATED THE FEMORAL VEIN. THERE WAS A DROP-IN PATIENT'S BLOOD PRESSURE. HOWEVER, NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED AS THE VESSEL WAS SELF-CLOSING. THE REMINDER OF THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS TRANSFERRED TO THE CORONARY CARE UNIT (CCU). THE PATIENT WAS REPORTED IN STABLE CONDITION. PHYSICIAN'S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT THE SOUNDSTAR CATHETER PERFORATED THE VEIN AT A TIGHT TURN IN THE VEIN. EXTENDED HOSPITALIZATION WAS NOT REQUIRED. PATIENT'S OUTCOME WAS FULLY RECOVERED. A THERMOCOOL SMART TOUCH SF CATHETER WAS INSIDE THE BODY, BUT RADIO FREQUENCY DELIVERY WAS NEVER APPLIED.

  Patient problems: Perforation of Vessels

  MAUDE report 9688691 ↗
• InjuryFeb 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT (B)(6) UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE FOR SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND SUFFERED VESSEL PERFORATION REQUIRING NO INTERVENTIONS. DURING THE PROCEDURE, WHEN TRYING TO GET ACCESS INTO THE RIGHT FEMORAL VEIN, THEY PERFORATED THE FEMORAL VEIN. THERE WAS A DROP-IN PATIENT¿S BLOOD PRESSURE. HOWEVER, NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED AS THE VESSEL WAS SELF-CLOSING. THE REMINDER OF THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS TRANSFERRED TO THE CORONARY CARE UNIT (CCU). THE PATIENT WAS REPORTED IN STABLE CONDITION. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT THE SOUNDSTAR CATHETER PERFORATED THE VEIN AT A TIGHT TURN IN THE VEIN. EXTENDED HOSPITALIZATION WAS NOT REQUIRED. PATIENT¿S OUTCOME WAS FULLY RECOVERED. A THERMOCOOL SMART TOUCH SF CATHETER WAS INSIDE THE BODY, BUT RADIO FREQUENCY DELIVERY WAS NEVER APPLIED.

  Patient problems: Perforation of Vessels

  MAUDE report 9661118 ↗
• InjuryNov 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION AFTER THE ST. JUDE/ABBOTT MEDICAL SL1 SHEATH, WHICH WAS IN LEFT ATRIUM, WAS EXCHANGED FOR ST. JUDE/ABBOTT MEDICAL 8.5 FRENCH AGILIS SHEATH. PERICARDIOCENTESIS WAS PERFORMED BY INTERVENTIONAL CARDIOLOGIST, AND 600 CC OF FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. HOWEVER, BLEEDING CONTINUED AFTER DRAINAGE. A CARDIOTHORACIC SURGEON WAS CONSULTED FOR SURGICAL REPAIR OF PERFORATION. TWO DAYS OF HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT'S OUTCOME IS FULLY RECOVERED. THE PHYSICIAN OPINION ON CAUSALITY OF THE EVENT IS THAT THIS WAS PROCEDURE RELATED. NO ERROR MESSAGES ON BIOSENSE WEBSTER, INC. EQUIPMENT WAS REPORTED. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE/ABBOTT MEDICAL 8.5 FRENCH AGILIS SHEATH, ST. JUDE/ABBOTT MEDICAL SL1 SHEATH, AND A ST. JUDE/ABBOTT MEDICAL BRK1 TRANSSEPTAL NEEDLE. NO ABLATION CATHETER WAS USED DURING THE PROCEDURE.

  Patient problems: Cardiac Tamponade; No Code Available

  MAUDE report 9286065 ↗
• InjuryNov 5, 2019Adverse 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 AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION AFTER THE ST. JUDE/ABBOTT MEDICAL SL1 SHEATH, WHICH WAS IN LEFT ATRIUM, WAS EXCHANGED FOR ST. JUDE/ABBOTT MEDICAL 8.5 FRENCH AGILIS SHEATH. PERICARDIOCENTESIS WAS PERFORMED BY INTERVENTIONAL CARDIOLOGIST, AND 600 CC OF FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. HOWEVER, BLEEDING CONTINUED AFTER DRAINAGE. A CARDIOTHORACIC SURGEON WAS CONSULTED FOR SURGICAL REPAIR OF PERFORATION. TWO DAYS OF HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME IS FULLY RECOVERED. THE PHYSICIAN OPINION ON CAUSALITY OF THE EVENT IS THAT THIS WAS PROCEDURE RELATED. NO ERROR MESSAGES ON BIOSENSE WEBSTER, INC. EQUIPMENT WAS REPORTED. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE/ABBOTT MEDICAL 8.5 FRENCH AGILIS SHEATH, ST. JUDE/ABBOTT MEDICAL SL1 SHEATH, AND A ST. JUDE/ABBOTT MEDICAL BRK1 TRANSSEPTAL NEEDLE. NO ABLATION CATHETER WAS USED DURING THE PROCEDURE.

  Patient problems: Cardiac Tamponade; No Code Available

  MAUDE report 9282215 ↗