Amplatzer™ TorqVue™ 45° x 45° Delivery Sheath (REF 9-TV45X45-12F-080)Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 05415067025883), received between Oct 8, 2018 and Jan 6, 2026 — classified as 2 deaths, 23 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Material Separation; Improper or Incorrect Procedure or Method; Scratched Material

  IT WAS REPORTED THAT ON (B)(6) 2025, A 12F AMPLATZER TORQVUE SHEATH WAS CHOSEN FOR A PROCEDURE. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE DEVICE SHAVINGS WERE VISIBLE ON THE ECHOCARDIOGRAPHY, AFTER THE DEVICE WAS CHANGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23981024 ↗
• MalfunctionNov 7, 2025Positioning Problem; Premature Separation; Positioning Problem; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 20MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. DURING PROCEDURE, THE DOC'S SHEATH CAME OUT OF THE APPENDAGE AND ACCIDENTALLY WENT ACROSS MITRAL VALVE WHILE IN BALL AND HIT THE MITRAL ANNULUS MULTIPLE TIMES. THE FIRST DEPLOYMENT WAS SO DEEP THAT IT WASN'T SEEN WELL ON IMAGING. THERE WERE MULTIPLE REDEPLOYMENTS AND A NEW 18MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN. DURING THE FIRST DEPLOYMENT OF THE SECOND DEVICE, WHEN THE DISC WAS DEPLOYED THE LOBE JUMPED UP MORE PROXIMALLY. THE DOC REDEPLOYED TWICE AND THEY LEFT A GOOD IMPLANT. AFTER RELEASE, A PERICARDIAL EFFUSION WAS NOTED THAT GREW BIGGER. A PERICARDIOCENTESIS WAS PERFORMED AND REMOVED 458CCS OF BLOOD. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497994 ↗
• MalfunctionAug 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2025, A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, IT WAS NOTED THAT THE TIP OF THE DELIVERY SHEATH WAS SPLIT UPON ATTEMPTING TO BE INSERTED INTO RIGHT FEMORAL VEIN. A NEW SHEATH WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22926329 ↗
• MalfunctionMay 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2025, A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WAS SELECTED FOR USE IN AN IMPLANT PROCEDURE. WHILE THE PHYSICIAN ATTEMPTED TO INSERT THE DILATOR AND SHEATH INTO THE PATIENT'S FEMORAL ARTERY, DIFFICULTY WAS NOTED. THE PHYSICIAN THEN EXAMINED THE TIP OF THE DILATOR AND IT WAS NOTED TO BE SPLIT DOWN THE MIDDLE. THE DEVICE WAS REPLACED WITH ANOTHER 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH TO RESOLVE THE EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS ONLY A MINIMAL DELAY ASSOCIATED WITH THE SHEATH REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21996508 ↗
• MalfunctionJan 30, 2025Difficult to Insert; Material Split, Cut or Torn; Difficult to Insert; Material Split, Cut or Torn

  IT WAS REPORTED THAT A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WAS SELECTED FOR A PROCEDURE ON (B)(6) 2025. THE DEVICE WAS PREPARED PER IFU. THE DELIVERY SHEATH WAS PLACED ON THE GUIDEWIRE; HOWEVER, IT WAS NOTED THAT DELIVERY SHEATH COULD NOT BE INSERTED INTO THE PATIENT. UPON INSPECTION THE DILATOR WAS SPLIT. THE DELIVERY SHEATH WAS REPLACED WITH A NEW 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21276275 ↗
• InjuryDec 27, 2024Use of Device Problem; Positioning Problem; Use of Device Problem; Positioning Problem

  IT WAS REPORTED THAT A 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. THE PATIENT WAS IN SINUS RHYTHM. THERE WERE TWO PREVIOUSLY FAILED ATTEMPTS TO IMPLANT A 27MM NON-ABBOTT DEVICE AND A 24MM NON-ABBOTT DEVICE. THE PATIENT HAD A COMPLEX, SHALLOW LEFT ATRIAL APPENDAGE. TRANSSEPTAL PUNCTURE WAS INFERIOR MID. THE PATIENT'S LEFT ATRIAL PRESSURE WAS 6MMHG. THE 22MM OCCLUDER WAS UNABLE TO BE IMPLANTED IN A STABLE LOCATION AND WAS RE-CAPTURED 3 TIMES. THE OCCLUDER WAS REMOVED FROM THE PATIENT. THE DECISION WAS MADE TO USE A 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER. DURING DEVICE PREPARATION IT WAS NOTED THAT THERE WAS A LOCALIZED AND GROWING CIRCUMFERENTIAL PERICARDIAL EFFUSION THAT WAS MEASURED APPROXIMATELY 1CM. A PERICARDIOCENTESIS WAS PERFORMED AND 300ML OF BLOOD WAS DRAINED FROM THE PERICARDIUM. THE PATIENT REMAINED STABLE AND WAS MONITORED. APPROXIMATELY 15 MINUTES LATER THE PATIENT WAS BLEEDING AGAIN AND THE DECISION WAS MADE TO CONVERT THE PATIENT TO SURGERY. DURING SURGERY A MODERATELY-SIZED PERFORATION WAS NOTED TO THE BACK WALL OF THE APPENDAGE. A NON-ABBOTT DEVICE WAS

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Pericardial Effusion

  MAUDE report 21028189 ↗
• InjuryDec 4, 2024Use of Device Problem; Use of Device Problem

  CLINICAL INFORMATION: (B)(4), PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, A 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. THE SHAPE OF THE APPENDAGE WAS CHICKEN WING AND THE ACTIVATED CLOTTING LEVELS WERE 269S AND THE AMULET WAS SUCCESSFULLY DEPLOYED IN THE LEFT ATRIAL APPENDAGE (LAA). POST PROCEDURE, THE PATIENT WAS NOTED HYPOTENSIVE AND COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) REVELED RUPTURE OF RIGHT COMMON FEMORAL ARTERY PSEUDOANEURYSM. THE PATIENT EXPERIENCED HEMORRHAGIC SHOCK AND RETROPERITONEAL HEMORRHAGE, RECEIVED TRANSFUSION OF 2 UNITS OF PACKED RED BLOOD CELLS (PRBC), FRESH FROZEN PLASMA (FFP) AND PLATELETS. THE PATIENT UNDERWENT EMERGENCY REPAIR BY VASCULAR SURGERY WITH PLACEMENT OF STENT IN RIGHT EXTERNAL ILIAC AND COMMON FEMORAL ARTERY WITH RESOLUTION. ON (B)(6) 2024, PATIENT WAS REPORTED STABLE AND GOT DISCHARGED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Pseudoaneurysm

  MAUDE report 20846567 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WAS SELECTED FOR PROCEDURE. THERE WAS NO DIFFICULTY/ISSUE USING THE 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH DURING PROCEDURE. ON (B)(6) 2024, IT WAS NOTED THAT THE PATIENT BEGAN TO EXPERIENCE PAIN AT THE ACCESS SITE OF THE 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. THE DECISION WAS MADE TO ADMINISTER THE PATIENT 30MG OF ORAL ROTUNDIN TABLETS. THE CAUSE OF THE PATIENT'S PAIN IS RELATED TO THE PATIENT'S TOLERANCE LEVEL. THERE IS NO ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVICE OR PROCEDURE. THE PATIENT WAS DISCHARGED AT THE TIME OF REPORT AND THERE WAS NO PROLONGED HOSPITALIZATION DUE TO THIS EVENT.

  Patient problems: Pain

  MAUDE report 20693011 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WAS SELECTED FOR A PROCEDURE ON (B)(6) 2024. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVELS WERE BETWEEN 350 AND 370 SEC. DURING THE PROCEDURE, AS THE DEVICE WAS BEGINNING TO BE INSERTED INTO THE PATIENT, A BLOOD CLOT WAS NOTED ON THE WIRE IN THE RIGHT ATRIUM ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS ABORTED. NO INTERVENTION WAS REQUIRED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20642439 ↗
• MalfunctionOct 24, 2024Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WAS SELECTED FOR A PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE IT WAS NOTED THAT THE DELIVERY SYSTEM COULD NOT BE ADVANCED THROUGH THE ATRIAL SEPTUM AND INTO THE LEFT ATRIUM. THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AND INSPECTED. IT WAS NOTED THAT THE DILATOR HAD SPLIT. THE USER REALIZED HE HAD ADVANCED THE DELIVERY SYSTEM OVER A NON-ABBOTT FLOPPY J-WIRE AND NOT THE REQUESTED NON-ABBOTT SUPER STIFF GUIDEWIRE. THE LAB TECH HAD NOT EXCHANGED THE WIRES. THE USER BELIEVED THE DILATOR SPLIT FROM CROSSING THE DELIVERY SYSTEM OVER THE WRONG WIRE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523144 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(6) - AMULET CHINA PMS, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, A 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS IMPLANTED IN A PATIENT USING A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. AN ATRIAL FIBRILLATION ABLATION WAS A CONCOMITANT PROCEDURE. ON (B)(6) 2024, THE PATIENT HAD CHEST PAIN FOR ONE DAY, WHICH WORSENED FOR 10 HOURS. THE PATIENT WENT TO AN OUTPATIENT DEPARTMENT TO COMPLETE RELEVANT EXAMINATIONS AND THEN WENT TO THE EMERGENCY DEPARTMENT. THE PATIENT WAS HOSPITALIZED DUE TO PERICARDITIS. THE PHYSICIAN CONSIDERED THAT USE OF ANTICOAGULATION MEDICATION CAUSED THE PERICARDITIS AFTER THE PROCEDURE. THE SUBCUTANEOUS BRUISING AT THE PUNCTURE SITE AND PAIN SYMPTOMS WERE ALLEVIATED AFTER ANTICOAGULATION MEDICATION WAS DISCONTINUED DURING THE HOSPITALIZATION. THE PATIENT WAS STABLE.

  Patient problems: Pain

  MAUDE report 20317046 ↗
• DeathSep 20, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 20MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 14F AMULET STEERABLE DELIVERY SHEATH. THE DELIVERY SYSTEM WAS ATTEMPTED TO BE USED BUT THEN WAS DOWNSIZED TO A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. THE AMULET OCCLUDER WAS IMPLANTED. AN ABBOTT PERCLOSE CLOSURE DEVICE WAS USED TO CLOSE THE ACCESS SITE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. UNDER AN HOUR AFTER THE PROCEDURE, THE PATIENT HAD DEVELOPED A HEMATOMA IN POST-OPERATIVE RECOVERY AT THE DELIVERY SYSTEM'S ACCESS SITE. A VENOUS PERFORATION OF UNDETERMINED LOCATION WAS DETERMINED TO BE PRESENT. CONTRALATERAL ACCESS WAS OBTAINED, AND STENTS WERE PLACED IN THE FEMORAL ARTERY AND THE FEMORAL VEIN IN ATTEMPT TO STOP THE BLEEDING. THE BLEEDING WAS UNABLE TO BE CONTROLLED. THIS VASCULAR COMPLICATION ULTIMATELY LED TO THE PATIENT'S DEATH. NO PERICARDIAL EFFUSION WAS NOTED.

  Patient problems: Hematoma; Perforation

  MAUDE report 20270527 ↗
• InjuryAug 26, 2024Material Invagination; Device Difficult to Setup or Prepare; Material Deformation; Material Invagination; Device Difficult to Setup or Prepare; Material Deformation

  IT WAS REPORTED THAT A 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. DURING THE PROCEDURE, SEVERAL ATTEMPTS WERE MADE TO ATTACH THE LOADING TUBE TO THE DELIVERY SHEATH FOR OCCLUDER INSERTION. UPON THE THIRD ATTEMPT IT WAS NOTED THAT THE INTERNAL CUFF OF THE LOADING TUBE APPEARED TO BE INVAGINATED, AND THE PLASTIC OF THE THREADS WERE DEFORMED. BOTH THE OCCLUDER AND DELIVERY SHEATH WERE REPLACED WITH A NEW 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE AND 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. THE PATIENT EXPERIENCED EXCESSIVE BLEEDING DUE TO THE DELAY IN ATTACHING THE LOADER TO THE DELIVERY SHEATH. ONE UNIT OF BLOOD WAS TRANSFUSED TO THE PATIENT POST-PROCEDURE. THE PATIENT STATUS WAS STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20071623 ↗
• MalfunctionAug 1, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, WHEN THE SHEATH EXCHANGE WAS ATTEMPTED AND DELIVERY SHEATH WAS ACCESSING THE GROIN, A KINK WAS NOTED. THE SHEATH WAS REMOVED AND A NEW 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19883632 ↗
• InjuryMay 31, 2024Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2024, A 20MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT USING A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. DURING THE PROCEDURE, THE TRANSSEPTAL PUNCTURE WAS INFERIOR AND POSTERIOR. HEPARIN WAS ADMINISTERED, AND THE ACTIVATED CLOTTING TIME (ACT) LEVEL WAS 330 SECONDS. IT WAS NOTED THAT THE DELIVERY SHEATH WAS RIDING THE PERICARDIAL WALL DUE TO ANGULATION NEAR THE TRANSVERSE SINUS WALL. THE DEVICE WAS ATTEMPTED TO BE IMPLANTED AND WAS PARTIALLY RETRACTED 3 TIMES. A 1.2MM PERICARDIAL EFFUSION WAS DETECTED ALONG THE PERICARDIAL WALL. THE DEVICE REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS STOPPED. THE PATIENT WAS ADMINISTERED PROTAMINE SULFATE. THE CAUSE OF THE PERICARDIAL EFFUSION WAS BELIEVED TO BE RELATED TO THE DELIVERY SHEATH. THE PATIENT STATUS WAS STABLE.

  Patient problems: Pericardial Effusion

  MAUDE report 19434532 ↗
• MalfunctionMay 24, 2024Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2024, A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH (LOT 9114597) WAS CHOSEN FOR PROCEDURE. IT WAS NOTED THAT THE PATIENT HAD A TOUGH ATRIAL SEPTUM WHICH WAS DIFFICULT TO CROSS. THERE WAS RESISTANCE DURING THE TRANSSEPTAL PUNCTURE, AND IT WAS CHALLENGING TO ADVANCE THE DELIVERY SYSTEM ACROSS THE SEPTUM. A NON-ABBOTT CATHETER WAS UTILIZED TO BALLOON THE SEPTUM TO 6MM. THE TIP OF THE DILATOR OF THE SHEATH BECAME FRAYED IN AN ATTEMPTED SEPTAL CROSSING, SO THE DEVICE WAS REPLACED WITH A NEW 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH (LOT 9137769). THE PHYSICIAN DID NOT BELIEVE TO BE IN "OUT OF BOX" CONDITION, AND THE PHYSICIAN REPORTED THAT THE DELIVERY SHEATH LOOKED "BEATEN UP." THE DEVICE WAS ATTEMPTED TO BE USED BUT RESULTED IN THE CATHETER LOOKING DAMAGED AND WAS UNABLE TO BE ADVANCED. THE DEVICE WAS REPLACED WITH ANOTHER 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH (LOT 9138439). THERE WAS MILD DIFFICULTY ADVANCING THE DELIVERY SHEATH, AND IT WAS REPORTED THAT THERE WAS A SLIGHT "HITCH" POINT WHERE THE DILATER TAPERS INTO THE SHEATH TIP. HOWEVER, THIS DEVICE WAS ABLE TO BE SUCCESSFULLY ADVANCED AND USED TO IMPLANT AN AMPLATZER AMULET LEFT ATRIAL APPE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19394056 ↗
• MalfunctionMay 24, 2024Product Quality Problem; Difficult to Advance; Material Deformation; Product Quality Problem; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH (LOT 9114597) WAS CHOSEN FOR PROCEDURE. IT WAS NOTED THAT THE PATIENT HAD A TOUGH ATRIAL SEPTUM WHICH WAS DIFFICULT TO CROSS. THERE WAS RESISTANCE DURING THE TRANSSEPTAL PUNCTURE, AND IT WAS CHALLENGING TO ADVANCE THE DELIVERY SYSTEM ACROSS THE SEPTUM. A NON-ABBOTT CATHETER WAS UTILIZED TO BALLOON THE SEPTUM TO 6MM. THE TIP OF THE DILATOR OF THE SHEATH BECAME FRAYED IN AN ATTEMPTED SEPTAL CROSSING, SO THE DEVICE WAS REPLACED WITH A NEW 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH (LOT 9137769). THE PHYSICIAN DID NOT BELIEVE TO BE IN "OUT OF BOX" CONDITION, AND THE PHYSICIAN REPORTED THAT THE DELIVERY SHEATH LOOKED "BEATEN UP." THE DEVICE WAS ATTEMPTED TO BE USED BUT RESULTED IN THE CATHETER LOOKING DAMAGED AND WAS UNABLE TO BE ADVANCED. THE DEVICE WAS REPLACED WITH ANOTHER 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH (LOT 9138439). THERE WAS MILD DIFFICULTY ADVANCING THE DELIVERY SHEATH, AND IT WAS REPORTED THAT THERE WAS A SLIGHT "HITCH" POINT WHERE THE DILATER TAPERS INTO THE SHEATH TIP. HOWEVER, THIS DEVICE WAS ABLE TO BE SUCCESSFULLY ADVANCED AND USED TO IMPLANT AN AMPLATZER AMULET LEFT ATRIAL APPE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393788 ↗
• InjuryMay 24, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. THE PATIENT WAS UNDER GENERAL SEDATION. NO ASPIRATION WAS PERFORMED. THE LOADER OF THE AMULET OCCLUDER WAS IMMEDIATELY CONNECTED TO THE SHEATH AFTER THE REMOVAL OF THE DILATOR. AFTER CONNECTING THE AMULET OCCLUDER TO THE DELIVERY SYSTEM, THERE WERE PROBLEMS WITH DE-AIRING THE SYSTEM. BLEEDBACK WAS OCCURRING, BUT AIR WOULD NOT LEAVE THE LOADER. THE DEVICE WAS NOT ABLE TO BE DE-AIRED. THE DEVICE WAS NOT ATTEMPTED FOR IMPLANT OR ADVANCED FOR DEPLOYMENT. THE AMULET OCCLUDER WAS REPLACED WITH A NEW 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER. THE DELIVERY SHEATH WAS NOT REPLACED. DURING THE DEPLOYMENT OF THE REPLACEMENT DEVICE, ST ELEVATIONS WERE NOTED, AND AN AIR EMBOLISM WAS SUSPECTED. ST ELEVATIONS RESOLVED WITHIN 10 MINUTES. NO TREATMENT WAS REQUIRED. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: Air Embolism; Non specific EKG/ECG Changes

  MAUDE report 19393216 ↗
• MalfunctionMay 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2024, A AMPLATZER AMULET WAS CHOSEN FOR IMPLANTATION UTILIZING A 12F TORQVUE DELIVERY SHEATH. ONCE THE SHEATH WAS INSERTED INTO THE PATIENT, A SPLIT WAS OBSERVED. THE DEVICE WAS REMOVED AND A REPLACEMENT DELIVERY SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19288316 ↗
• InjuryMay 3, 2024Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT A 20MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR A PROCEDURE ON (B)(6) 2024 USING A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. DURING THE PROCEDURE IT WAS NOTED THAT IT WAS DIFFICULT TO ADVANCE THE DEVICE THROUGH THE SHEATH DUE TO A KINK ON THE DELIVERY SHEATH. THE DELIVERY SHEATH WAS NOT REPLACED. THE LOADER WAS IMMEDIATELY CONNECTED TO THE SHEATH AFTER REMOVAL OF THE GUIDEWIRE. AFTER THE DEVICE WAS POSITIONED ON THE APPENDAGE THE PATIENT PRESENTED WITH ST ELEVATIONS. NO INTERVENTIONS WERE PERFORMED AND THE ST ELEVATION RESOLVED ON ITS OWN AFTER 10 MINUTES. THE DEVICE WAS IMPLANTED. THE PATIENT DID NOT PRESENT WITH ANY OTHER CLINICAL SIGNS OR SYMPTOMS. IT WAS BELIEVED THAT THE ST ELEVATIONS WERE CAUSED BY AN AIR EMBOLISM BUT NO AIR BUBBLES WERE VISUALIZED. THE PATIENT STATUS WAS STABLE.

  Patient problems: Air Embolism; Non specific EKG/ECG Changes

  MAUDE report 19241923 ↗
• MalfunctionApr 17, 2024

  AMULET SHEATH INSERTED INTO PATIENT. SPLIT NOTED IN SHEATH. SHEATH REMOVED AND REPLACED. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19125775 ↗
• InjuryMar 28, 2024Use of Device Problem; Use of Device Problem

  CLINICAL INFORMATION: (B)(6) STUDY, PATIENT SITE ID: (B)(6) IT WAS REPORTED THAT ON 22 MARCH 2022, A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WAS USED DURING A PROCEDURE. AFTER THE PROCEDURE, IT WAS NOTED THAT DRAINAGE WAS RUNNING DOWN PATIENT'S LEG FROM THE ACCESS SITE OF THE DELIVERY SYSTEM AT THE GROIN. MANUAL PRESSURE WAS APPLIED FOR 50 MINUTES BEFORE A PRESSURE DRESSING WAS APPLIED AND THE DRAINAGE WAS CONTROLLED. THE PATIENT STATUS WAS STABLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18995378 ↗
• InjuryJan 11, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 20MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER TORQVUE 45 X 45 DELIVERY SHEATH (DS). THE PATIENT HAD PREVIOUSLY HAD A FAILED WATCHMAN ATTEMPTED AND AN ATRIAL FIBRILLATION ABLATION. THE SIZING OF THE DEVICE WAS DETERMINED BY PRE-PROCEDURE IMAGES VS. INTRA-PROCEDURE IMAGES VS. ANGIOGRAPHY MEASUREMENT OF 15.6. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY WITH THE TRANS-SEPTAL PUNCTURE. ONCE ACCESS WAS OBTAINED, THE PHYSICIAN WAS HAVING DIFFICULTY ADVANCING THE DS. THE PHYSICIAN THEN THOUGHT THAT HE HAD LOST ACCESS THE THE LEFT ATRIUM, SO THE DS WAS REMOVED AND NON-ABBOTT CATHATER WAS PUT BACK IN. HEPARIN WAS ADMINISTERED AND THE ACTIVATED CLOTTING LEVELS (ACT) WERE DRAWN WITH A RESULT OF 336. IT WAS THEN NOTED THAT THERE WAS A KINK IN THE TORQVUE DS, SO A NEW 12F AMPLATZER TORQVUE 45 X 45 DELIVERY SHEATH WAS CHOSEN AND TO CONTINUE THE PROCEDURE. THE LEFT ATRIAL (LA) PRESSURE WAS 12MM HG. THERE WAS A DIFFICULTY TO GETTING INTO THE LEFT LOWER PULMONARY VEIN (LUPV) AND THEN THE PIGTAIL TO LEFT ATRIAL APPENDAGE. AFTER SEVERAL DEPLOYMENTS, IT WAS NOTED THAT THERE WAS A LEAK NOTED SO THE PHYSICIA

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18499109 ↗
• InjuryDec 8, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WAS ELECTED TO IMPLANT A DEVICE. DURING PROCEDURE, THE PHYSICIAN STRUGGLED GETTING SHEATH ACROSS SEPTUM DURING THE TRANSSEPTAL PUNCTURE (TSP) AND DID NOT WANT TO ADMINISTER HEPARIN UNTIL THE SHEATH WAS SUCCESSFULLY ACROSS THE SEPTUM. HEPARIN WAS NOT IMMEDIATELY GIVEN POST TSP. SEVERAL MINUTES PASSED WITH EQUIPMENT IN LEFT ATRIUM (LA) BEFORE HEPARIN WAS GIVEN. THE FIRST ACTIVATED CLOTTING TIME (ACT) LEVEL WAS 227 SECONDS AND DID NOT DEMONSTRATE THERAPEUTIC LEVELS. ADDITIONAL HEPARIN WAS ADMINISTERED, AND THE SECOND ACT WAS 293 SECONDS. A THROMBUS NOTED IN LA WHILE THE PHYSICIAN WAS TRYING TO ACCESS LEFT ATRIAL APPENDAGE (LAA). THE DELIVERY SHEATH AND NON-ABBOTT PIGTAIL CATHETER WERE IN THE LA AT THE TIME. THE DELIVERY SHEATH AND PIGTAIL CATHETER WERE BOTH ASPIRATED IN ATTEMPT TO REMOVE THE CLOT. BOTH THE DELIVERY SHEATH AND THE PIGTAIL CATHETER WERE CAREFULLY REMOVED FROM THE PATIENT, AND THROMBUS WAS NOTED ON THE TIP OF THE PIGTAIL CATHETER. THOROUGH TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING DID NOT SHOW A THROMBUS ANYWHERE ELSE IN THE HEART OR SURROUNDING AREAS. THE PROCEDURE WAS THEN ABORTED, AN

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18297509 ↗
• MalfunctionDec 1, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON(B)(6) 2023, A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WAS CHOSEN FOR THE PROCEDURE. IT WAS INDICATED THAT THE DILATOR TIP SPLIT. A REPLACEMENT 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18246596 ↗