Liberator Beacon Tip G26550Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00827002265509), received between Feb 18, 2016 and Apr 6, 2026 — classified as 2 deaths, 18 injuries.

The most frequently reported specific device problem is “Break” (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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION IS EXCERPTED FROM A CASE REPORT TITLED, "HIGHLY COMPLICATED LEAD EXTRACTION PROCEDURE IN PATIENT WITH PREVIOUS EARLY ORTHOTOPIC HEART TRANSPLANTATION: A FIRST CASE REPORT" (SCHILLACI, ET AL.). AN RV [RIGHT VENTRICULAR] LEAD ACTIVE FIXATION WAS UNSCREWED FROM THE ENDOCARDIUM, AND A LOCKING STYLET (LIBERATOR COOK MEDICAL, BLOOMINGTON, IN, USA) WAS EXCHANGED WITH THE STANDARD ONE. THE [LIBERATOR] LOCKING STYLET WAS HARDLY ADVANCED TILL OBSTRUCTION SITE, AND SIMPLE TRACTION WAS ATTEMPTED. THE SIMPLE TRACTION PROVED UNSUCCESSFUL, AND A NEW ATTEMPT WAS PERFORMED USING A LASER DILATOR SHEATH (SPECTRANETICS 14FR, COLORADO SPRINGS, CO) ADVANCED OVER THE [LIBERATOR] LEAD/LOCKING STYLET COMPLEX. HOWEVER, IT WAS NOT POSSIBLE TO ADVANCE THE LASER DILATOR SHEATH OVER THE OBSTRUCTION DUE TO THE PRESENCE OF IMPORTANT CALCIFICATION AT SUPERIOR VENA CAVA/JUNCTION OF THE BRACHIOCEPHALIC VEINS. MOREOVER, DURING THE LEAD TRACTION, A DISTAL COIL MIGRATION TO THE CAVOATRIAL JUNCTION (CAJ) OCCURRED, AND RV LEAD FRACTURED PROXIMALLY TO THE OBSTRUCTION. ABOUT LV [LEFT VENTRICULAR] LEAD REMOVAL, THE LOCKING STYLET (LIBERATOR COOK MEDICAL) WAS NOT ADVANCED TO THE DISTAL PORTION DUE T

  Patient problems: Foreign Body In Patient

  MAUDE report 24792356 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  DURING A VENTRICULAR LEAD REMOVAL PROCEDURE, CARDIAC TAMPONADE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE SUBJECT DEVICE (LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET) WAS ADVANCED USING A 12 FR LASER SHEATH (NON-COOK DEVICE; UNKNOWN MANUFACTURER). ALTHOUGH STRONG ADHESIONS WERE ENCOUNTERED AROUND THE TRICUSPID VALVE, THE DEVICE WAS ABLE TO PASS. CARDIAC TAMPONADE OCCURRED DURING COUNTER-TRACTION. OPEN CHEST SURGERY WAS PERFORMED TO MANAGE THE CARDIAC TAMPONADE. THE RELATIONSHIP BETWEEN THE LEAD REMOVAL DEVICE AND THE EVENT REMAINS UNKNOWN.

  Patient problems: Cardiac Tamponade

  MAUDE report 24778396 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS RECEIVED THROUGH THE FDA'S MEDWATCH PROGRAM VIA MEDWATCH REPORT#: MW5182082: "A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD DUE TO CIED/POCKET INFECTION. COOK MEDICAL LIBERATORS WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. DURING THE EXTRACTION OF THE RA LEAD UTILIZING A SPECTRANETICS GLIDELIGHT LASER SHEATH, THE RA LEAD WAS REMOVED AND THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS. IT WAS SUSPECTED THERE WAS A RA PERFORATION, AND THE PATIENT SURVIVED THE PROCEDURE. THE PHYSICIAN BELIEVES THE CAUSE OF THE PERFORATION WAS DUE TO TRACTION WITH THE LIBERATOR." NOTE THAT CIED = CARDIAC IMPLANTABLE ELECTRONIC DEVICE. B3: 'DATE OF EVENT' WAS NOT PROVIDED BY THE REPORTER.

  Patient problems: Cardiac Perforation; Low Blood Pressure/ Hypotension

  MAUDE report 24472543 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO COOK JAPAN FROM THE USER FACILITY: A SCREW-IN RIGHT VENTRICLE (RV) LEAD WAS FITTED WITH A LIBERATOR BEACON TIP LOCKING STYLET (LR-OFA01), AND DURING DISSECTION WITH A 16F LASER (MANUFACTURED BY ANOTHER COMPANY), THE PATIENT¿S BLOOD PRESSURE DROPPED. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED, AND AN OPEN-CHEST SURGERY WAS CONDUCTED, DURING WHICH A DEFECT WAS FOUND NEAR THE RIGHT ATRIUM (RA) ¿SUPERIOR VENA CAVA (SVC) REGION. THE DEFECT WAS REPAIRED, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). ALTHOUGH APPROXIMATELY 3 CM OF THE LEAD TIP REMAINED, THE REST OF THE LEAD AND LR-OFA01 WERE REMOVED. REGARDING THE RETAINED LEAD TIP, IT WAS DETERMINED BY THE PHYSICIAN THAT NO ADDITIONAL REMOVAL PROCEDURE WOULD BE PERFORMED. ACCORDING TO THE PHYSICIAN, THE LASER (NON-COOK DEVICE) USED FOR LEAD STRIPPING WAS CONSIDERED TO BE THE DIRECT CAUSE OF THE REPORTED EVENT. ADDITIONAL INFORMATION WAS LATER PROVIDED TO A COOK SALES REPRESENTATIVE, INDICATING THE PATIENT REMAINED IN THE ICU AND WAS UNABLE TO BE WEANED FROM THE PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) SYSTEM.

  Patient problems: Intraoperative Cardiac Injury; Low Blood Pressure/ Hypotension

  MAUDE report 24349666 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  2X LR-OFA01 DEVICES INSERTED INTO RIGHT ATRIUM (RA)1 & RIGHT VENTRICLE (RV)1 LEFT SIDED PACING LEADS DUE FOR EXTRACTION. 3RD LIBERATOR (LOT NUMBER N215551) INSERTED AND ACTIVATED WITHIN TARGETED RV2 LEAD. ONETIE APPLIED. TRACTION APPLIED AND NO RETRACTION NOTED. ACTIVATED CORRECTLY WITH GUIDED INSTRUCTION FROM MERIT SUPPORT PERSONNEL). RA1 LEAD, LIBERATOR PULLED BACK LEAVING ACTIVE FILAMENT PORTION OF DEVICE STILL INSIDE OF TARGETED LEAD. RV1 LEAD, ACTIVATED AND FIXED WITH ONETIE PROXIMAL COMPRESSION COIL. WHEN DIRECT TRACTION APPLIED, LIBERATOR BEGAN TO RETRACT WITHIN THE LEAD, PULLED BACK TO SUBCLAVIAN REGION OF BODY. DEVICE APPEARED INTACT WITHIN THE LEAD, BEACON TIP MARKER VISIBLE WITHIN SUBCLAVIAN REGION OF LEAD.

  Patient problems: Foreign Body In Patient

  MAUDE report 23693263 ↗
• InjurySep 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY THREE YEARS AFTER IMPLANTATION, REMOVAL OF A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RESULTED IN CARDIAC TAMPONADE DUE TO DAMAGE TO THE FREE WALL OF THE RIGHT ATRIUM. THE LEFT VENTRICLE (LV) LEAD HAD ALREADY COME OUT OF THE CORONARY SINUS VEIN AT THE START AND HAD BEEN PULLED INTO THE RIGHT ATRIAL CAVITY, BUT IT WAS STUCK DUE TO ADHESION BETWEEN THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) LEAD AND THE LV LEAD. A 12FR GLIDELIGHT (EXCIMER LASER SHEATH) WAS USED TO PEEL AWAY THE ADHESION BETWEEN THE LV LEAD AND THE ICD LEAD. PEELING WAS SUCCESSFUL UP TO THE THIRD ELECTRODE, BUT COULD NOT PROCEED FURTHER, SO A 14FR GLIDELIGHT WAS USED INSTEAD. WHILE ADVANCING THE SHEATH OVER THE ICD LEAD, CARDIAC TAMPONADE OCCURRED UPON REACHING THE RIGHT ATRIUM. THE TAMPONADE OCCURRED SOLELY DUE TO ADVANCING THE SHEATH, WITHOUT ANY LASER IRRADIATION PRIOR TO REACHING THE RIGHT ATRIUM. THE LIBERATOR WAS IN THE LV LEAD FROM THE INITIAL STAGE OF LEAD DETACHMENT UNTIL THE COMPLICATION OCCURRED. AT THE TIME THE COMPLICATION OCCURRED, IT WAS INSERTED INTO THE STYLET LUMEN OF THE LEAD IN QUESTION. THE EVOLUTION 9FR SHORTIE ONLY REACHED AS FAR AS THE SUPERIOR VENA CAVA, SO I

  Patient problems: Cardiac Tamponade; Great Vessel Perforation

  MAUDE report 23123518 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ATRIAL LEAD AND AN ICD LEAD HAD BEEN / HAVE BEEN PLACED FROM THE LEFT ANTERIOR CHEST. SINCE THE ICD LEAD BROKE, THE LEAD REMOVAL WAS ATTEMPTED. OFA01 WAS USED FOR BOTH LEADS AS A LOCKING STYLET (TOTALLY, TWO OFA01 WERE USED), AND PHILIPS'S LASER SHEATH 14FR AND 16FR WERE USED FOR ADHESION REMOVAL. BOTH TIPS OF ATRIAL LEAD AND AN ICD LEAD CAME OFF, BUT BOTH STUCK AROUND AT SVC. HEMOTHORAX OCCURRED DURING THE 16FR LASER SHEATH BEING USED AROUND SVC, AND THE CHEST WAS OPENED. HEMOSTASIS WAS ACCOMPLISHED BY OPENING THE CHEST. IT IS NOT CONFIRMED WHETHER THE TARGET LEADS WHICH INCLUDE OFA01 COULD BE SURGICALLY REMOVED FROM ANATOMY SURGICALLY AT THE SAME TIME. ADDITIONAL INFORMATION PROVIDED ON 7 JULY 2025. THE SURGEON FINISHED THE OPEN CHEST SURGERY BUT LEFT THE LEADS IN THE PATIENT. THE LEAD TIPS WERE AT AROUND THE JUNCTION OF THE SVC AND THE RA, AND THE LIBERATORS REMAIN INSIDE THE LEAD. 'BAILOUT' FOR THE LIBERATORS WERE NOT PERFORMED. INFORMATION UPDATED ON 8 JULY 2025. THE VENTRICULAR LEAD HAD BEEN REMOVED, AND ONLY THE ATRIAL LEAD REMAINS.

  Patient problems: Hemothorax

  MAUDE report 22814154 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WITH A DUAL CHAMBER (DDD) PACEMAKER IMPLANTED. SURGERY WAS STARTED WITH THE PLAN TO REMOVE ONLY THE RA LEAD AND IMPLANT A NEW LEAD. A LIBERATOR WAS INSERTED INTO THE RA LEAD. THE LEAD WAS FIXED USING A ONE-TIE AS WELL. A BYRD DILATOR SHEATH 8.5FR WAS USED TO DISSECT FROM THE INSERTION SITE TO THE SUPERIOR VENA CAVA (SVC) PROXIMAL PART. CHANGED TO AN EVOLUTION 9FR + STEADY SHEATH AND DISSECTION WAS PERFORMED UP TO THE FRONT OF THE RING ELECTRODE, BUT IT COULD NOT PROCEED ANY FURTHER. WHEN THE DISSECTION WAS CONTINUED AFTER CHANGING TO A PHILIPS GLIDELIGHT 14FR, THE TIP OF THE LEAD BROKE OFF AND REMAINED. THE LEAD REMOVAL WAS COMPLETED AS A CLINICAL SUCCESS, AND AS PREPARATIONS WERE BEING MADE TO IMPLANT A NEW RA LEAD, THE PATIENT'S BLOOD PRESSURE GRADUALLY DECREASED, DROPPING FROM THE 90S IMMEDIATELY AFTER REMOVAL TO THE 70S. PERICARDIAL FLUID ACCUMULATION WAS CONFIRMED BY A TRANSESOPHAGEAL ECHOCARDIOGRAPHY, AND CARDIAC TAMPONADE WAS DIAGNOSED. AFTER PERICARDIAL DRAINAGE, BLOOD PRESSURE RECOVERED FROM THE 60S TO THE 80S. DRAINAGE WAS CONTINUED WHILE BLOOD TRANSFUSION WAS PERFORMED. AS BLOOD PRESSURE STABILIZED, A NEW RA LEAD WAS PLACED AND THE SURGERY WAS COMPLETED. THE SU

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 20636823 ↗
• DeathAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICES INVOLVED: LR-OFA01 (LOT N205140) --- APPROACHED FROM THE LEFT SUBCLAVIAN VEIN FOR RV LEAD. LR-NES001 (LOT N199524) --- APPROACHED FROM THE LEFT SUBCLAVIAN VEIN FOR RV LEAD. LR-EVN-SH-9.0-RL (LOT N202627) --- APPROACHED FROM THE LEFT SUBCLAVIAN VEIN FOR RV LEAD. LR-PPLBES-10.0 (LOT N202202) --- APPROACHED FROM THE LEFT SUBCLAVIAN VEIN FOR RV LEAD. PHILIPS / 518-067 / LEAD LOCKING DEVICE KIT (LOT FLK24C05A). PHILIPS /500-303 / GLIDELIGHT LASER SHEATH 16FR (LOT FGC22K05A). SHORTLY AFTER SUCCESSFULLY COMPLETING TLE (TRANSVENOUS LEAD EXTRACTION), THE PATIENT'S BLOOD PRESSURE DROPPED TO THE 50S. TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS PERFORMED TO CHECK FOR PERICARDIAL EFFUSION, BUT THERE WAS NO CHANGE FROM BEFORE SURGERY. ANGIOGRAPHY OF THE SVC (SUPERIOR VENA CAVA) WAS PERFORMED, BUT THERE WAS NO INDICATION OF DAMAGE TO THE SVC. AT THE SURGEON'S INSTRUCTION, THE PATIENT WAS CONNECTED TO PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS), AND HER BLOOD PRESSURE IMPROVED FROM THE 40S TO THE 100S. THE SURGEONS DIAGNOSED HER WITH A SUSPECTED PULMONARY EMBOLISM. THE PATIENT WAS CONNECTED TO PCPS AND RETURNED TO THE ICU AFTER SURGERY. HER CONDITION WILL BE IMPROVED BY ADMINISTERING MEDICATION.

  Patient problems: Great Vessel Perforation; Low Blood Pressure/ Hypotension; Pulmonary Embolism

  MAUDE report 20047238 ↗
• InjuryAug 14, 2024Break; Entrapment of Device; Break; Entrapment of Device

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A 74-YEAR-OLD MALE PATIENT UNDERWENT A LEAD EXTRACTION/ HEART PROCEDURE IN WHICH THE LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET, (B)(6), WAS USED. THE ELECTRODE IS DEBRIDED FROM THE PACEMAKER BAG, THE STYLET WIRES ARE INTRODUCED TO RELEASE FIXATION AND VERIFY PATENCY, THE CONNECTOR IS CUT AND THE LIBERATOR GUIDE IS INTRODUCED, MAKING SURE THAT IT REACHES THE DISTAL TIP OF THE ELECTRODE BY MEANS OF FLUOROSCOPY. UPON REACHING THE MOST DISTAL PART OF THE ELECTRODE, THE SPIKES ARE RELEASED FROM THE GUIDE. DUE TO THE TRACTION INFERRED AT THE MOMENT OF RELEASING, IT IS SEPARATED FROM THE EXTENSOR OF THE SAME, BRINGING THE EXTERNAL LUMEN OF THE GUIDE, LEAVING THE INNER PART OF THE LIBERATOR INSIDE THE CABLE AND THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19980324 ↗
• InjuryFeb 12, 2024Break; Mechanical Problem; Break; Mechanical Problem

  PER EMAIL RECEIVED ON (B)(6)2024: SHE UNDERWENT A SURGICAL PROCEDURE AS AN INFANT KNOWN AS A MUSTARD PROCEDURE, WHICH AT THE TIME, WAS THE ACCEPTED METHOD OF CORRECTING THE BLOOD FLOW, BUT HAD THE ADDED COMPLICATION OF THE PACEMAKER LEADS BEING IN THE LEFT ATRIUM AND VENTRICLE. SHE HAD A MEDTRONIC 4057 PACEMAKER LEAD PLACED IN 1993 AT 9 YEARS OLD, WHICH CLEARLY FRACTURED AND WAS ABANDONED, REQUIRING A NEW SYSTEM IN 2005 (LA GUIDANT 4470, LV MDT 5076). RECENTLY, THE 4470 ATRIAL LEAD BEGAN MALFUNCTIONING AND BEING PACING DEPENDENT, REQUIRED ANOTHER REVISION. THE LEFT BRACHIOCEPHALIC VEIN CONTAINING THE LEADS WAS COMPLETELY OCCLUDED WITH CONSIDERABLE COLLATERALS PROVIDING BLOOD RETURN. LEAD PREPARATION WAS PERFORMED FIRST, WITH DISSECTION DOWN TO THE BROKEN FRAGMENT OF THE OLD LEAD, WHICH TOOK A CONSIDERABLE AMOUNT OF TIME TO LOCATE. LIBERATORS WERE PLACED IN EACH LEAD AND DR. (B)(6) CHOSE NOT TO UTILIZE ONETIES FOR PROXIMAL SUPPORT. 4057 ¿ LIBERATOR LOT #N199513. 5076 ¿ LIBERATOR LOT #N199030. 4470 ¿ LIBERATOR LOT #N198962 (INITIAL). LOT #N199030 X 2 (SUBSEQUENT). THE 5076 LEAD WAS TARGETED FIRST AND EXTRACTED USING A COMBINATION OF LASER AND MECHANICAL EXTRACTION WITH A14FR EXCIMER

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 18687776 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER EMAIL RECEIVED ON 18JAN2024: SHE UNDERWENT A SURGICAL PROCEDURE AS AN INFANT KNOWN AS A MUSTARD PROCEDURE, WHICH AT THE TIME, WAS THE ACCEPTED METHOD OF CORRECTING THE BLOOD FLOW, BUT HAD THE ADDED COMPLICATION OF THE PACEMAKER LEADS BEING IN THE LEFT ATRIUM AND VENTRICLE. SHE HAD A MEDTRONIC 4057 PACEMAKER LEAD PLACED IN 1993 AT 9 YEARS OLD, WHICH CLEARLY FRACTURED AND WAS ABANDONED, REQUIRING A NEW SYSTEM IN 2005 (LA GUIDANT 4470, LV MDT 5076). RECENTLY, THE 4470 ATRIAL LEAD BEGAN MALFUNCTIONING AND BEING PACING DEPENDENT, REQUIRED ANOTHER REVISION. THE LEFT BRACHIOCEPHALIC VEIN CONTAINING THE LEADS WAS COMPLETELY OCCLUDED WITH CONSIDERABLE COLLATERALS PROVIDING BLOOD RETURN. LEAD PREPARATION WAS PERFORMED FIRST, WITH DISSECTION DOWN TO THE BROKEN FRAGMENT OF THE OLD LEAD, WHICH TOOK A CONSIDERABLE AMOUNT OF TIME TO LOCATE. LIBERATORS WERE PLACED IN EACH LEAD AND DR. BASHIR CHOSE NOT TO UTILIZE ONETIES FOR PROXIMAL SUPPORT. 4057 ¿ LIBERATOR LOT #N199513. 5076 ¿ LIBERATOR LOT #N199030. 4470 ¿ LIBERATOR LOT #N198962 (INITIAL). LOT #N199030 X 2 (SUBSEQUENT). THE 5076 LEAD WAS TARGETED FIRST AND EXTRACTED USING A COMBINATION OF LASER AND MECHANICAL EXTRACTION WITH A14FR EXCIMER L

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 18687148 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATTEMPTED TO DETACH THE ADHESION OF THE ATRIAL LEAD WITH EVNSH9, THE BLOOD PRESSURE DROPPED TO ABOUT 20 WHEN THE TIP OF THE INNER SHEATH WAS ABOUT TO ENTER THE SUBCLAVIAN VEIN AND HAS NOT RISEN SINCE. PROBABLY PERICARDIAL DRAINAGE AND POSSIBLY OPEN THORACOTOMY. ON (B)(6) 2023 ADDITIONAL INFORMATION WAS OBTAINED: TARGET SITE WAS RIGHT ATRIUM AND ACCESS SITE WAS LEFT SUBCLAVIAN VEIN. ON (B)(6) 2023 ADDITIONAL INFORMATION WAS PROVIDED BY THE PHYSICIAN: 1) THE CAUSE OF CARDIAC TAMPONADE THAT OCCURRED DURING LEAD REMOVAL USING COOK PRODUCTS (EVN AND OFA) WAS THAT THE LEAD TIP, WHICH WAS TINED TO THE INNER WALL OF THE ATRIUM, RUPTURE THE ATRIUM. 2) THE REASON WHY THE LEAD TIP RUPTURED THE ATRIUM WAS THE STRUCTURE OF THE LEAD STRUCTURE (TINED TIP (PASSIVE FIXATION) , NOT THOSE COOK PRODUCTS. 3) THE RUPTURE AREA WAS IMMEDIATELY OPENED AND SUTURED SURGICALLY.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 17622817 ↗
• DeathMay 3, 2017Device Operates Differently Than Expected; Appropriate Device Problem Term/Code Not Available; Device Operates Differently Than Expected; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING A LEAD REMOVAL PROCEDURE TO EXTRACT A NON-FUNCTIONAL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEAD WHICH WAS IMPLANTED FROM RIGHT SIDE. THE BLOOD PRESSURE WAS 210/100MMHG AT THE BEGINNING OF THE PROCEDURE. THE LEAD WAS PREPPED USING A LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET. THE PHYSICIAN BEGAN THE EXTRACTION USING A LASER SHEATH FROM A DIFFERENT MANUFACTURER. THE USE OF THE LASER SHEATH WAS STOPPED WHEN IT COULD NOT MAKE ANY FURTHER PROGRESS AT THE INNOMINATE VEIN / SUPERIOR VENA CAVA JUNCTION. THE PHYSICIAN PULLED THE LEAD AND THE BLOOD PRESSURE DROPPED TO 50MMHG. THE PHYSICIAN APPLIED CHEST COMPRESSIONS AND ADMINISTRATED ADRENALINE. AN EFFUSION WAS NOTED AND THE LEAD WAS EXTRACTED MANUALLY BY SIMPLE TRACTION. PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) WAS APPLIED. THE PHYSICIAN IMMEDIATELY PERFORMED A PERICARDIAL DRAINAGE. BLOOD PRESSURE WAS RESTORED TO 80MMHG. THE PHYSICIAN NOTED THE EFFUSION AGAIN AND THE BLOOD PRESSURE DROPPED AGAIN. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM AND A STERNOTOMY WAS PERFORMED. A TEAR OF ABOUT 7CM WAS CONFIRMED AT THE RIGHT ATRIUM WALL. THE TEAR WAS REPAIRED UNDER OPEN CHES

  Patient problems: Death

  MAUDE report 6541747 ↗
• InjuryApr 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, THE EXTRACTING PHYSICIAN WAS PULLING TENSION ON A LIBERATOR LOCKING STYLET AND ADVANCING AN EVOLUTION RL (9FR). THE EVOLUTION RL WAS PROXIMAL TO THE BRACHIOCEPHALIC VEIN WHEN THERE WAS A NOTED DROP IN BLOOD PRESSURE. AT THIS POINT THE PATIENT WAS TAKEN FOR AN OPEN CHEST PROCEDURE. AT THIS POINT IT WAS NOTED THAT BOTH LEADS WERE BOUND TOGETHER AND TO THE VESSEL WALL. THE ADHESION WAS CALCIFIED AND ALSO ATTACHED TO THE VESSEL WALL. ONCE THE HEART LEADS REMOVED FROM THE VESSEL WALL, THE TEAR OCCURRED WHICH CAUSED THE DROP IN BLOOD PRESSURE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY.

  Patient problems: Blood Loss; Low Blood Pressure/ Hypotension

  MAUDE report 6464017 ↗
• InjuryDec 13, 2016Device Slipped; Device Slipped

  IT WAS REPORTED THAT DURING A LEAD EXTRACTION PROCEDURE, A LIBERATOR AND ONE TIE WAS USED. WHILE USING TRACTION TO EXTRACT THE LEAD, THE LIBERATOR AND ONE TIE SLIPPED AND PULLED AWAY FROM THE LEAD TIP. THE PHYSICIAN THEN ATTACHED SUTURE TIES TO THE LEAD TO TRY AND MAKE IT MORE SECURE, THEN AS MORE TRACTION WAS USED, THE LEAD SNAPPED AND THE LOCKING STYLET AND PARTIAL LEAD CAME OUT. THE PATIENT SUFFERED A RIGHT ATRIAL PERFORATION. THE PHYSICIAN PERFORMED A SUB XIPHOID WINDOW AND REPAIRED THE PERFORATION. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: Atrial Perforation; Unspecified Infection

  MAUDE report 6169383 ↗
• InjuryApr 7, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN PLACED THE LIBERATOR LOCKING STYLET DOWN THE PACEMAKER LEAD. THE LOCKING STYLET WENT HALF WAY DOWN AND WAS NOT ABLE TO BE ADVANCE FURTHER. THE DOCTOR STARTED TO PLACE THE 11FR EVOLUTION OVER THE PACEMAKER LEAD WHEN THE LEAD PULLED BACK AND WAS FREE. THE ADHESION ON THE PACEMAKER LEAD PULLED A HOLE IN THE HEART MUSCLE THAT CAUSE A RIP. THE DOCTOR THEN STARTED TO OPEN THE PATIENT CHEST TO REPAIR THE RIP. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. NO ADDITIONAL ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: Cardiac Perforation

  MAUDE report 5553776 ↗
• InjuryMar 24, 2016Break; Break

  PHYSICIAN WAS REMOVING A CORONARY SINUS LEAD FROM THE (B)(6) MALE PATIENT. THE FIRST LOCKING STYLET WAS PLACED IN THE LEAD AND ENGAGED TO LOCK, BUT UPON PULLING TO REMOVE, IT SLIPPED BACK AND WAS NOT LOCKED. THE DEVICE WOULD NOT LOCK ON SECOND ATTEMPT. AT THIS POINT THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED. UPON TRYING TO LOCK THE SECOND LIBERATOR, THE LIBERATOR BROKE APPROXIMATELY 5CM DISTAL TO THE WELD. FORCEPS WERE USED TO PULL OUT THE BROKEN PIECE ALONG WITH THE LEAD AS INTENDED. THE PROCEDURE WAS ULTIMATELY SUCCESSFULLY COMPLETED WITH NO PATIENT HARM. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 5522555 ↗
• InjuryFeb 18, 2016Material Separation; Material Separation

  MIDWAY INTO THE CASE THE LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET BROKE ABOUT 5CM DISTAL TO THE WELD WHERE IT ATTACHES TO THE BRAIDED HANDLE. THERE WAS ENOUGH OF THE LIBERATOR REMAINING OUTSIDE OF THE PROXIMAL TO WHERE THE SURGEON, USING HEMOSTATS, COULD GRAB AND SUCCESSFULLY REMOVE THE LEAD. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5444340 ↗
• InjuryFeb 18, 2016Material Separation; Material Separation

  DURING AN ELECTRODE PULLING TECHNIQUE (HEART) PROCEDURE ON THE (B)(6) MALE PATIENT, THE SURGEON EXTRACTED THE ELECTRODE AND FOUND THE LOCKING STYLET WAS DETACHED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH OTHER EQUIPMENT. THE LOCKING STYLET HAS BEEN REMOVED FROM THE PATIENTS BODY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 5444151 ↗