SOUNDSTAR 10439236Recalls & reported problems

Summary

The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 10846835008869), received between Feb 9, 2018 and Sep 1, 2026 — classified as 4 deaths, 29 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (61 reports).

1 other recall cover devices cleared under the same FDA submission (K140318); they may or may not involve this specific model.

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 107 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Patient Device Interaction Problem

  It was reported that a patient underwent an Atrial Tachycardia ablation procedure with a QDOT MICRO catheter and a SOUNDSTAR catheter and the patient experienced cardiac perforation and syncope which required pericardiocentesis.After the Atrial Tachycardia ablation with the QDOT catheter, a pericardial effusion was noticed. The patient had been stable during the entire procedure. Thirty-five minutes after the patient left the room post ablation, the patient had a drop in blood pressure and they became unconscious. It was unknown how the pericardial effusion was confirmed. The medical intervention provided was a pericardiocentesis and 180cc of fluid was removed. An additional 900 mL fluid was removed during the night after the procedure. Patient stayed in the hospital for two nights because the effusion grew. The patient was reported to be in stable condition.They found a trace pericardial effusion in the left ventricle before the procedure and when they checked on intracardiac echocardiogram after the procedure, the pericardial effusion was the same. The physician could not confirm what caused the pericardial effusion after the procedure but believed the SOUNDSTAR catheter may have

  Patient problems: Cardiac Perforation; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 50545889 ↗
• InjuryDec 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VARIPULSE¿ BI-DIRECTIONAL CATHETER AND A SOUNDSTAR CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED DRAINAGE AND PROLONGED HOSPITALIZATION. DURING THE PROCEDURE, CARDIAC TAMPONADE OCCURRED. DURING POST-MAPPING, THE CARTO 3 SCREEN FROZE AND WAS FORCED TO RESTART. THE FORCED RESTART OCCURRED DURING POST-MAPPING. WHILE THE SYSTEM WAS BEING RESTORED, THE PATIENT¿S BLOOD PRESSURE DROPPED. INTRACARDIAC ECHOCARDIOGRAPHY WAS PERFORMED AND REVEALED THE PERICARDIAL EFFUSION. DRAINAGE WAS PERFORMED. A DECREASE IN THE PERICARDIAL EFFUSION AND STABILIZATION OF THE PATIENT¿S VITALS WAS CONFIRMED, AND THE PATIENT WAS OBSERVED IN THE INTENSIVE CARE UNIT. AFTER THE CARTO 3 WORKSTATION (WS) MAIN POWER WAS FORCIBLY TERMINATED, THE WS WAS REBOOTED AND THE SYSTEM WAS SUBSEQUENTLY RESTORED. THE PHYSICIAN ASSESSMENT OF THE HEALTH PROBLEM WAS SERIOUS. THE PHYSICIAN'S OPINION ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS AS A RESULT OF BLOOD-GAS ANALYSIS, THE ACCUMULATED BLOOD WAS VENOUS. EXTENDED HOSPITALIZATION WAS REPORTED. THE VARIPULSE CATHETER, WHICH HAD BEEN MANEUVERED IN THE LEFT ATRIUM, WAS UNLIKELY TO

  Patient problems: Cardiac Tamponade

  MAUDE report 23873725 ↗
• InjuryDec 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR CATHETER AND THE PATIENT EXPERIENCED CARDIAC PERFORATION TREATED WITH PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT DURING AN AFIB CASE WITH A PERICARDIAL EFFUSION WAS NOTICED IN THE PATIENT. THE PHYSICIAN WAS CHECKING INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WITH THE SOUNDSTAR CATHETER AND A PERICARDIAL EFFUSION WAS NOTICED. THE PERICARDIAL EFFUSION WAS CONFIRMED VIA ECHO. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS; IT IS UNKNOWN HOW MUCH FLUID WAS REMOVED. THE PATIENT WAS IN STABLE CONDITION. THE PHYSICIAN BELIEVES THAT THE SOUNDSTAR CATHETER MAY HAVE CAUSED A PERFORATION, AS THE PHYSICIAN WAS HAVING DIFFICULTY ACCESSING THE VENTRICLE, BUT THE INFORMATION HAS NOT YET BEEN CONFIRMED. A NEW VARIPULSE CATHETER WAS OPENED FOR THE PROCEDURE, BUT IT WAS NEVER INSERTED INTO THE PATIENT. A WEBSTER CS CATHETER AND A SOUNDSTAR CATHETER WERE THE ONLY BWI DEVICES INSIDE THE PATIENT FOR THE PROCEDURE. NO ABLATION HAD BEEN PERFORMED FOR THE PROCEDURE. ADDITIONAL INFORMATION WAS LATER RECEIVED INDICATING THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PATIENT

  Patient problems: Cardiac Perforation

  MAUDE report 23824162 ↗
• MalfunctionDec 15, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A SOUNDSTAR CATHETER. THE SOUNDSTAR CATHETER HAD PLASTIC MATERIAL ATTACHED TO THE HANDLE IN MULTIPLE LOCATIONS WHERE IT SHOULD NOT BE, RIGHT OUT OF THE PACKAGE. THE CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. THE ISSUE WAS NOTICED BEFORE USE ON THE PATIENT. NO PICTURE AVAILABLE. MATERIAL OBSERVED WAS EMBEDDED TO THE DEVICE. CONFIRMED THAT THE SECTION OF THE CATHETER THAT THE ISSUE WAS FOUND WAS THE HANDLE. NO PHYSICAL DAMAGE NOTED. JUST THE FOREIGN MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23805188 ↗
• MalfunctionDec 5, 2025Contamination /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 AND SOME "TAGADERM" WAS ON THE TIP OF THE CATHETER. IT WAS REPORTED THAT THE PHYSICIAN NOTICED THAT SOME "TAGADERM" WAS ON THE TIP OF THE CATHETER. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. REPLACEMENT CATHETER REQUESTED. THE CATHETER WAS BRAND NEW AND NOT REPROCESSED. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23724450 ↗
• MalfunctionDec 4, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR CATHETER WHICH HAD THE DEFLECTION MECHANISM "STUCK." THE CALLER REPLACED THE SOUNDSTAR® CATHETER AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS ABLE TO CONTINUE WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23723508 ↗
• MalfunctionOct 29, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR AND THERE WAS DEBRIS ON THE INSIDE OF THE CATHETER BOX. THE ISSUE WAS DISCOVERED WHEN THEY OPENED THE CATHETER. THE CATHETER WAS BRAND NEW FROM BWI BOX PACKAGING. THEY DID NOT FEEL COMFORTABLE USING THE CATHETER, SO THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE CASE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23411290 ↗
• MalfunctionOct 20, 2025Contamination /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) PROCEDURE WITH A SOUNDSTAR CATHETER AND A STICKY ADHESIVE SUBSTANCE WAS ON THE CATHETER. THEY OPENED AND REMOVED A SOUNDSTAR CATHETER FROM ITS PACKAGING AND NOTICED A "STICKY ADHESIVE" SUBSTANCE WAS ON THE CATHETER. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THE CALLER NOTED THAT IT WAS A BRAND NEW CATHETER. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. NO PATIENT CONSEQUENCE REPORTED. THE NGEN¿ GENERATOR WAS IN USE. ADDITIONAL INFORMATION WAS RECEIVED. THE ISSUE ON THE SOUNDSTAR CATHETER WAS NOTICED BEFORE USE, AS SOON AS THE CATHETER WAS REMOVED FROM THE PACKAGING AND THE CATHETER WAS NOT USED ON THE PATIENT. THE MATERIAL LOOKED LIKE REMNANTS OF TAPE, IT WAS NOT MOVING AND LOOKED LIKE WHITE/TRANSPARENT STICKY ADHESIVE. THEY DO NOT HAVE THE PACKAGING BUT THEY DO HAVE THE CATHETER AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23344010 ↗
• MalfunctionOct 16, 2025Material Twisted/Bent; Mechanical Jam; Positioning Problem; Material Twisted/Bent; Mechanical Jam; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A SOUNDSTAR ECO AND THE DEFLECTION MECHANISM BECAME STUCK. AFTER INSERTING THE CATHETER INTO THE CARDIAC CAVITY AND PERFORMING BROCKENBROUGH, APPROXIMATELY ONE HOUR AFTER USING IT IN THE LEFT ATRIUM (TO CONFIRM THE SITE FOR ABLATION WITH FARAPULSE) THE PHYSICIAN REPORTED THAT ITS BEHAVIOR WAS DIFFERENT FROM USUAL. AFTER BENDING THE SOUNDSTAR ECO CATHETER ON THE P SIDE, IT DID NOT RETURN TO THE CENTER AND REMAINED UNABLE TO BECOME FLAT. IT APPEARED TO HAVE DEVELOPED A BEND OR KINK, AND EVEN WHEN BENT ON THE A SIDE, THE CATHETER DID NOT STRAIGHTEN OUT. SINCE IT WAS JUST BEFORE THE END OF THE PROCEDURE, THE PHYSICIAN INSTRUCTED NOT TO REPLACE THE CATHETER, AND THE PROCEDURE WAS COMPLETED AS IT WAS. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. ADDITIONAL INFORMATION RECEIVED INDICATED THE KNOB WAS ABLE TO BE TURNED AND/OR PUSHED UP AND DOWN BUT THE CATHETER WAS STUCK. THE CATHETER COULD NOT BE FLATTENED, EVENT WHEN SHAPED BY HAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23318983 ↗
• MalfunctionAug 27, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A SOUNDSTAR ECO GE 8F CATHETER AND THERE WAS ADHERENT MATERIAL ON THE TIP OF THE CATHETER (SOMETHING LIKE A FILM). THE MATERIAL WAS IDENTIFIED WHEN THE STERILE PACKAGING OF THE WAS OPENED. THE DEVICE WAS NOT INSERTED INTO THE PATIENT. ADHERENT MATERIAL WAS LOOSE, AND IT WAS POSSIBLE TO WIPE IT OFF WITH A MOISTENED GAUZE, BUT THE NATURE OF THE ADHERENT MATERIAL WAS UNKNOWN. THE PROCEDURE WAS CONTINUED WITH CATHETER REPLACEMENT (AND THE ADHERENT MATERIAL WAS DISCARDED ALONG WITH THE GAUZE). THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22901751 ↗
• MalfunctionMar 14, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A SOUNDSTAR AND A KNOTTED CATHETER ISSUE WAS OBSERVED. THE SOUNDSTAR CATHETER WAS NOT ABLE TO BE MANIPULATED CORRECTLY AND WHEN TRYING TO PULL THE CATHETER OUT, THE CATHETER HAD A LOOP AND WAS NOT COMING OUT OF THE SHEATH. THEY DECIDED TO USE FLUOROSCOPY AND AFTER GAGING VISUALIZATION OF THE CATHETER, IT WAS KNOTTED. THE PHYSICIAN PUSHED THE CATHETER IN AND OUT OF THE SHEATH AND MANAGED TO RELEASE THE KNOT. THE CATHETER WAS PULLED AND THEN REPLACED. THE PROBLEM WAS RESOLVED. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. IN THE PHYSICIAN¿S OPINION, THE CATHETER¿S ISSUE DID NOT PUT THE PATIENT AT RISK FOR A POTENTIAL HARM OR INJURY. THERE WAS RESISTANCE TRYING TO REMOVE THE CATHETER, WHICH TOLD US IT WAS KNOTTED. ONCE THE CATHETER WAS VISUALIZED UNDER FLUOROSCOPY AND STRAIGHTENED OUT, THERE WAS NO RESISTANCE REMOVING THE CATHETER FROM THE SHEATH. NO DETACHMENT OF ANY COMPONENT. THE LOOP/TIP BECAME UNKNOTTED. THE ISSUE DID NOT RESULT IN EXPOSURE OF ANY INTERNAL CATHETER COMPONENTS OR SHARP EDGES. FLUOROSCOPY IMAGES WERE NOT SAVED, SO NO IMAGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21611558 ↗
• MalfunctionMar 4, 2025Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR AND A HOLE IN STERILE PACKAGING WAS FOUND. IT WAS REPORTED BY THE CALLER THAT WHEN PREPARING TO OPEN THE CATHETER, IT WAS NOTICED THERE WAS A PIN HOLE IN THE PACKAGING. THE CALLER SAW THE HOLE WHILE REMOVING THE CATHETER FROM THE BOX. THE HOLE GOES THROUGH BOTH LEVELS OF STERILE PACKAGING. THE CALLER REPLACED THE CATHETER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21521432 ↗
• MalfunctionMar 2, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A SOUNDSTAR. IT WAS REPORTED THAT THE LOCKING MECHANISM ON THE SOUNDSTAR CATHETER WAS "STUCK" AND IT WOULD NOT UNLOCK. THE SOUNDSTAR CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS THE LOCKING KNOB THAT WAS STUCK. IT SEEMED LIKE THE PHYSICIAN DEFLECTED THE CATHETER AND WAS UNABLE TO RESTORE TO NEUTRAL BECAUSE THE CATHETER LOCK MECHANISM WOULD NOT RELEASE. THE CURVE OF THE CATHETER WAS STUCK/JAMMED IN A FULL/PARTIAL DEFLECTED POSITION. THE FAILURE WAS FOUND PRIOR TO INSERTION INTO THE BODY. THERE WAS NO RING, ELECTRODE OR OTHER PHYSICAL DAMAGE OBSERVED AT THE DISTAL END OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21501272 ↗
• InjuryJan 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED PERICARDIOCENTESIS AND SURGICAL INTERVENTION. AFTER SOUND MERGE WAS PERFORMED IN LEFT ATRIUM USING SOUND STAR ECO CATHETER, BROCKENBROUGH WAS PERFORMED TO APPROACH THE LEFT ATRIUM. AFTER PRE LA (LEFT ATRIUM) MAPPING WAS PERFORMED BY OCTARAY, RPV (RIGHT PULMONARY VEIN) ABLATION WAS ABOUT TO BE ATTEMPTED USING SMART TOUCH SF CATHETER UNDER CS1-2 PACING. BUT BLOOD PRESSURE WAS FOUND TO BE DECREASED JUST BEFORE THE ABLATION START. THE SOUND STAR ECO CATHETER WAS INSERTED IN RIGHT VENTRICLE, LEFT VENTRICULAR SHORT AXIS VIEW WAS DRAWN, AND PERICARDIAL FLUID WAS OBSERVED. AFTER VASOPRESSOR WAS ADMINISTERED, THE VITAL WAS IMPROVED, AND THE RPV ABLATION WAS STARTED AT THE PHYSICIAN¿S DISCRETION. AFTER ABLATING THE ENTIRE CIRCUMFERENCE OF THE RPV, WHEN THE LPV (LEFT PULMONARY VEIN) WAS ABLATED AT THREE POINTS, THE BLOOD PRESSURE DROPPED AND PERICARDIAL FLUID INCREASED, SO EMERGENT PERICARDIAL DRAINAGE WAS PERFORMED. AT THAT POINT, THE ABLATION WAS TERMINATED. THE PATIENT'S BLOOD PRESSURE ROSE TRANSIENTLY, BUT THE V

  Patient problems: Cardiac Perforation

  MAUDE report 21117167 ↗
• MalfunctionDec 31, 2024Mechanical Jam; Positioning Problem; Mechanical Jam; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE AND THE LOCKING MECHANISM FOR THE SOUNDSTAR CATHETER GOT STUCK AND WOULD NOT UNLOCK. THE SOUNDSTAR CATHETER WAS REPLACED, AND THE ISSUE WAS RESOLVED. PROCEDURE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21049055 ↗
• MalfunctionNov 22, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A SOUNDSTAR CATHETER AND A STEERING MECHANISM "GETTING STUCK¿ ISSUE OCCURRED. IT WAS REPORTED BY THE CALLER THAT THE PHYSICIAN STATED THE SOUNDSTAR CATHETER STEERING MECHANISM WAS "GETTING STUCK". THIS WAS NOTED TOWARD THE END OF THE PROCEDURE AND THE CATHETER WAS NOT REPLACED. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE CURVE OF THE CATHETER WAS STUCK IN A PARTIALLY DEFLECTED POSITION. NOT KNOWN IF THE KNOB/PISTON WAS UNABLE TO BE TURNED AND / OR PUSHED UP AND DOWN. NO DIFFICULTY IN REMOVING THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20765625 ↗
• InjuryAug 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION AND THE PATIENT EXPERIENCED CARDIAC PERFORATION / PERICARDIAL EFFUSION THAT REQUIRED MEDICATION. AN ATRIAL PERFORATION AND EFFUSION WERE CAUSED BY THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER. WHILE GETTING READY TO DRAW CONTOURS, THE PERFORATION WAS VISUALIZED IN ICE AND CONFIRMED BY TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE PATIENT WAS PROVIDED WITH "NEO" TO RAISE BLOOD PRESSURE. THE PATIENT WAS IN STABLE CONDITION AND WAS ADMITTED FOR OBSERVATION OVERNIGHT.

  Patient problems: Cardiac Perforation

  MAUDE report 20072613 ↗
• MalfunctionJul 23, 2024Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem; Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A SOUNDSTAR CATHETER AND WHEN THE PHYSICIAN TOOK THE SOUNDSTAR CATHETER OUT OF THE BOX, AND STARTED TO USE IT BY INSERTING TO PATIENT, HE NOTICED SOMETHING WHITE THAT WAS ON THE TIP OF CATHETER. THE SIZE WAS VERY SMALL, AND IT WAS LIKE A WHITE DOT. THE PHYSICIAN THOUGHT THAT THIS ONE IS CONTAMINATED AND REQUESTED TO CHANGE IT WITH NEW ONE TO CONTINUE WITH THE PROCEDURE SAFELY. THE DEVICE WAS NOT USED ON THE PATIENT AND THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19813052 ↗
• MalfunctionMay 1, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER AND A WHITE POWDER WAS FOUND ON THE HANDLE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE WHITE POWDER WAS ONLY FOUND ON THE CATHETER. IT WAS DESCRIBED AS "SMALL POWDERY" MATERIAL THAT WAS LOOSE. THE DEVICE WAS NOT USED ON THE PATIENT. IT WAS REPLACED AND THE CASE CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19227083 ↗
• MalfunctionApr 25, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER AND A WHITE POWDER WAS FOUND ON THE HANDLE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE WHITE POWDER WAS ONLY FOUND ON THE CATHETER. IT WAS DESCRIBED AS ¿SMALL POWDERY¿ MATERIAL THAT WAS LOOSE. THE DEVICE WAS NOT USED ON THE PATIENT. IT WAS REPLACED AND THE CASE CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19187840 ↗
• MalfunctionMar 24, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB)- PAROXYSMAL ABLATION PROCEDURE WHICH INCLUDED A SOUNDSTAR. ECO 8FG ULTRASOUND CATHETER AND THERE WAS WHITE DEBRIS FOUND ON THE SOUNDSTAR CATHETER WHEN IT WAS REMOVED FROM THE. PACKAGING. THE CATHETER WAS NOT USED. IT WAS EXCHANGED TO CONTINUE THE CASE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18966615 ↗
• MalfunctionMar 8, 2024Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PAROXYSMAL ABLATION PROCEDURE WHICH INCLUDED A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER AND THERE WAS WHITE DEBRIS FOUND ON THE SOUNDSTAR CATHETER WHEN IT WAS REMOVED FROM THE PACKAGING. THE CATHETER WAS NOT USED. IT WAS EXCHANGED TO CONTINUE THE CASE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18871306 ↗
• MalfunctionNov 13, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER AND A FOREIGN MATERIAL WAS OBSERVED. IT WAS REPORTED BY THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE THAT WHEN THEY OPENED A CATHETER FOR THEIR FIRST CASE, THERE WAS FOREIGN MATERIAL IN IT. THEY NOTICED SMALL WHITE PARTICLES IN VARIOUS SIZES FROM TINY ROUND TO SMALL ROUND ALONG THE CATHETER AND MAINLY ALONG THE HANDLE. IT WAS LOOSE AND MOST OF IT HAD COME OFF BY THE TIME IT WAS GIVEN TO THE BWI REPRESENTATIVE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18124154 ↗
• MalfunctionNov 3, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER AND A FOREIGN MATERIAL WAS OBSERVED. IT WAS REPORTED BY THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE THAT WHEN THEY OPENED A CATHETER FOR THEIR FIRST CASE, THERE WAS FOREIGN MATERIAL IN IT. THEY NOTICED SMALL WHITE PARTICLES IN VARIOUS SIZES FROM TINY ROUND TO SMALL ROUND ALONG THE CATHETER AND MAINLY ALONG THE HANDLE. IT WAS LOOSE AND MOST OF IT HAD COME OFF BY THE TIME IT WAS GIVEN TO THE BWI REPRESENTATIVE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18068448 ↗
• InjuryOct 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE USING SOUNDSTAR ECO 8FG ULTRASOUND CATHETER AND DECANAV ELECTROPHYSIOLOGY CATHETER. THE PATIENT EXPERIENCED HEART BLOCK THAT REQUIRED IMPLANTATION OF TEMPORARY PACEMAKER. THE PATIENT DEVELOPED TRANSIENT HEART BLOCK DURING THE PROCEDURE. THIS OCCURRED PRIOR TO ANY ABLATION AND PRIOR TO TRANSSEPTAL ACCESS. UPON REVIEW OF THE STUDY USING THE TIMELINE FEATURE, THERE WERE NO CATHETERS NEAR THE HIS/ ATRIOVENTRICULAR (AV) NODE. PRIOR TO ADVANCING THE DECANAV AND RIGHT VENTRICLE (RV) QUAD CATHETERS INTO THE PATIENT, THERE WAS RIGHT BUNDLE BRANCH BLOCK NOTED. THE SOUNDSTAR ECO 8FG ULTRASOUND CATHETER HAD ALREADY BEEN ADVANCED AND WAS FLOATING IN THE RIGHT ATRIUM. AFTER ALL THE CATHETERS WERE PLACED, A WIRE WAS ADVANCED TO THE SUPERIOR VENA CAVA AND THE HEART BLOCK WAS THEN NOTED. THE PHYSICIAN IS UNSURE HOW/WHY THE HEART BLOCK OCCURRED. THE PATIENT WAS IN AF AT THE BEGINNING OF THE PROCEDURE, SO NO AV NODE INTERVAL MEASUREMENTS COULD BE RECORDED. A TEMPORARY PACEMAKER WAS PLACED AT THIS TIME. THE PATIENT WAS CURRENTLY STABLE AND INTERMITTENTLY IN SINUS RHYTHM, WITH A LONG PR INTERVAL. BIOSENSE WEBSTER, INC. PRODUCTS USED

  Patient problems: Heart Block

  MAUDE report 17990281 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140318. One submission often covers many models, so check the product and lot details in each record.

• Z-0003-2016 · Sep 10, 2015 · Terminated
  SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualiza