Amplatzer™ TorqVue™ 45° x 45° Delivery Sheath (REF 9-TV45X45-14F-080)Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 05415067025906), received between May 24, 2021 and Sep 18, 2026 — classified as 7 deaths, 23 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (35 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 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Difficult to Advance; Material Split, Cut or Torn

  It was reported that on (b)(6) 2026, a 14F Amplatzer Amulet Delivery Sheath was chosen for a procedure. The patient was reported to have tortuous anatomy, which made advancement of the delivery sheath and dilator difficult. Prior to the procedure, the delivery sheath was inspected for damage, kinks, or obstructions. The device was properly flushed and prepared according to the IFU before attempting delivery. During removal of the sheath and dilator, a tear was observed in the dilator. As a result, the delivery system was replaced with a new 14F Amplatzer Amulet Delivery Sheath (Lot: 11347613). Upon use of a second delivery system, a similar issue was encountered. The physician subsequently removed the system to further dilate the vascular access site. During removal, it was noted that the guidewire had split the second TorqVue delivery system. Later, a third delivery system which is a 14F Amplatzer Amulet Delivery Sheath (Lot: 11347613) was successfully used to complete the procedure. The physician reported that the issue was not with the delivery system, but rather the patient's difficult anatomy. The patient remained hemodynamically stable throughout the procedure. There was no c

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819077 ↗
• MalfunctionSep 18, 2026Material Split, Cut or Torn

  It was reported that on (b)(6) 2026, a 14F Amplatzer Amulet Delivery Sheath was chosen for a procedure. The patient was reported to have tortuous anatomy, which made advancement of the delivery sheath and dilator difficult. Prior to the procedure, the delivery sheath was inspected for damage, kinks, or obstructions. The device was properly flushed and prepared according to the IFU before attempting delivery. During removal of the sheath and dilator, a tear was observed in the dilator. As a result, the delivery system was replaced with a new 14F Amplatzer Amulet Delivery Sheath (Lot: 11347613). Upon use of a second delivery system, a similar issue was encountered. The physician subsequently removed the system to further dilate the vascular access site. During removal, it was noted that the guidewire had split the second TorqVue delivery system. Later, a third delivery system which is a 14F Amplatzer Amulet Delivery Sheath (Lot: 11347613) was successfully used to complete the procedure. The physician reported that the issue was not with the delivery system, but rather the patient's difficult anatomy. The patient remained hemodynamically stable throughout the procedure. There was no c

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819047 ↗
• MalfunctionSep 8, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50680143 ↗
• MalfunctionMar 20, 2026Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2026, A 14 F AMPLATZER TORQVUE DELIVERY SHEATH WAS CHOSEN FOR A PROCEDURE. THE DELIVERY SHEATH WAS INSPECTED FOR DAMAGE, KINKS, OR OBSTRUCTIONS PRIOR TO USE AND FOUND ACCEPTABLE, AND IT WAS PROPERLY FLUSHED AND PREPARED PER THE IFU BEFORE DELIVERY. THE PATIENT¿S ANATOMY WAS REPORTED TO BE TORTUOUS. DURING ADVANCEMENT OF THE DELIVERY SYSTEM OVER THE WIRE INTO THE FEMORAL ACCESS SITE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE SHEATH AND ENCOUNTERED RESISTANCE IMMEDIATELY PAST THE SKIN. THE DELIVERY SYSTEM HAD NOT CONTACTED THE GUIDEWIRE PRIOR TO THE SPLIT TIP BEING NOTICED (PLACING OVER THE WIRE, NO DAMAGE VISUALIZED). AFTER MULTIPLE ATTEMPTS, THE PHYSICIAN REMOVED THE SHEATH OVER THE WIRE AND OBSERVED THAT THE DILATOR WAS DAMAGED, WITH A SMALL TEAR AT ITS DISTAL END. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING A NEW 14F AMPLATZER TORQVUE DELIVERY SHEATH. 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 24651966 ↗
• MalfunctionFeb 2, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2026, A 22MM AMPLATZER AMULET WAS CHOSEN FOR A PROCEDURE USING A 14 F AMPLATZER TORQVUE DELIVERY SYSTEM. IT WAS OBSERVED THAT THE DELIVERY SYSTEM'S SHEATH SPLIT WHILE ADVANCING UP THE PATIENT'S GROIN. THERE WAS NO DAMAGE OBSERVED PRIOR TO OPENING AND THE FLUSHING WAS DONE ACCORDING TO IFU. THE DELIVERY SYSTEM WAS REPLACED BY A 14F AMULET STEERABLE DELIVERY SHEATH. 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 24240462 ↗
• DeathJan 20, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED ON 22 DECEMBER 2025, TWO 14F DELIVERY SYSTEMS WERE CHOSEN TO BE USED IN THE PROCEDURE DURING THE CASE. ONE TORQVUE SHEATH WAS INITIALLY USED, AND A SECOND TORQVUE SHEATH WAS SUBSEQUENTLY INTRODUCED AFTER PLACEMENT OF AN OUTER SHEATH DUE TO THE TORTUOUS VEIN. THE DELIVERY SHEATH AND PIGTAIL CATHETER WERE POSITIONED AT THE OSTIUM OF THE APPENDAGE. THE FIRST RAU/CRANIAL FLUOROSCOPIC IMAGE WAS OBTAINED. AS THE TEAM PREPARED TO ACQUIRE THE RAU/CAUDAL IMAGE, THE PATIENT¿S BLOOD PRESSURE BECAME SOFT. THE PROCEDURE WAS STOPPED IMMEDIATELY, AND THE DELIVERY SHEATH AND PIGTAIL CATHETER WERE REMOVED FROM THE LEFT ATRIUM. CHEST COMPRESSIONS WERE INITIATED. A PLEURAL EFFUSION WAS IDENTIFIED INTRAPROCEDURALLY ONCE CHEST COMPRESSIONS BEGAN, AND THIS EFFUSION WAS ASSESSED AS NOT RELATED TO THE PROCEDURE OR THE ABBOTT DEVICES. THE COMPRESSIONS WERE REPORTED TO HAVE WORSENED THE EFFUSION, AND THE PATIENT¿S PRESSURES DID NOT RECOVER. THE PLEURAL EFFUSION COULD NOT BE RESOLVED, AS THE PATIENT NEVER BECAME STABLE ENOUGH FOR INTERVENTION. IMAGING CONFIRMED THE EFFUSION DURING RESUSCITATIVE EFFORTS. THE PATIENT ULTIMATELY EXPIRED ON (B)(6) 2025, WITH THE CAUSE OF DEATH DOCUMENTED AS PLEUR

  Patient problems: Low Blood Pressure/ Hypotension; No Clinical Signs, Symptoms or Conditions; Pleural Effusion

  MAUDE report 24122413 ↗
• DeathJan 20, 2026Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON 22 DECEMBER 2025, TWO 14F DELIVERY SYSTEMS WERE CHOSEN TO BE USED IN THE PROCEDURE DURING THE CASE. ONE TORQVUE SHEATH WAS INITIALLY USED, AND A SECOND TORQVUE SHEATH WAS SUBSEQUENTLY INTRODUCED AFTER PLACEMENT OF AN OUTER SHEATH DUE TO THE TORTUOUS VEIN. THE DELIVERY SHEATH AND PIGTAIL CATHETER WERE POSITIONED AT THE OSTIUM OF THE APPENDAGE. THE FIRST RAU/CRANIAL FLUOROSCOPIC IMAGE WAS OBTAINED. AS THE TEAM PREPARED TO ACQUIRE THE RAU/CAUDAL IMAGE, THE PATIENT¿S BLOOD PRESSURE BECAME SOFT. THE PROCEDURE WAS STOPPED IMMEDIATELY, AND THE DELIVERY SHEATH AND PIGTAIL CATHETER WERE REMOVED FROM THE LEFT ATRIUM. CHEST COMPRESSIONS WERE INITIATED. A PLEURAL EFFUSION WAS IDENTIFIED INTRAPROCEDURALLY ONCE CHEST COMPRESSIONS BEGAN, AND THIS EFFUSION WAS ASSESSED AS NOT RELATED TO THE PROCEDURE OR THE ABBOTT DEVICES. THE COMPRESSIONS WERE REPORTED TO HAVE WORSENED THE EFFUSION, AND THE PATIENT¿S PRESSURES DID NOT RECOVER. THE PLEURAL EFFUSION COULD NOT BE RESOLVED, AS THE PATIENT NEVER BECAME STABLE ENOUGH FOR INTERVENTION. IMAGING CONFIRMED THE EFFUSION DURING RESUSCITATIVE EFFORTS. THE PATIENT ULTIMATELY EXPIRED ON (B)(6) 2025, WITH THE CAUSE OF DEATH DOCUMENTED AS PLEUR

  Patient problems: Low Blood Pressure/ Hypotension; Pleural Effusion

  MAUDE report 24122238 ↗
• MalfunctionJan 5, 2026Retraction Problem; Improper or Incorrect Procedure or Method; Material Twisted/Bent

  IT WAS REPORTED THAT (B)(6) 2025, A 14F AMPLATZER TORQVUE SHEATH WAS CHOSEN FOR A PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO RECAPTURE A 31MM AMULET DEVICE THROUGH THE 14F SHEATH FOR DEVICE REMOVAL. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS, THE PHYSICIAN UTILIZED BALLOONING OF THE CATHETER TIP TO FACILITATE RECAPTURE OF THE DEVICE INTO THE DELIVERY SHEATH. THE DELIVERY CATHETER HAD PREVIOUSLY BEEN USED FOR TWO DEVICE RESIZING ATTEMPTS. THE PHYSICIAN WAS INFORMED THAT, PER THE INSTRUCTIONS FOR USE (IFU), THE DELIVERY SYSTEM SHOULD BE REPLACED WITH EACH FULL RECAPTURE AND EXCHANGE OF THE DEVICE. DESPITE THIS, THE SAME CATHETER WAS USED. DURING DEVICE PREPARATION, WAS THERE NO ISSUE RETRACTING DEVICE INTO THE DELIVERY SYSTEM. POST-PROCEDURE ASSESSMENT REVEALED THE CATHETER WAS KINKED IN TWO LOCATIONS. THE PHYSICIAN NOTED THAT THE PATIENT¿S TORTUOUS ANATOMY MAY HAVE CONTRIBUTED TO THE ISSUE. 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 23967817 ↗
• MalfunctionDec 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE SHEATH DILATOR SPLIT WAS NOTICED AFTER BEING USED AND HAD TO USE AGAIN DUE TO REDOING TRANSEPTAL. A NEW 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT WAS REPORTED STABLE AND DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851433 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 23729851 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) - VERITAS, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM AMPLATZER AMULET 2 WAS CHOSEN FOR IMPLANT. POST-PROCEDURE ON (B)(6) 2025, A TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) NOTED A LEFT TO RIGHT RESIDUAL SHUNT THROUGH THE TRANSSEPTAL PUNCTURE. NO TREATMENT OR INTERVENTION WAS REQUIRED.

  Patient problems: Perforation

  MAUDE report 23605860 ↗
• MalfunctionOct 6, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ON (B)(6) 2025 A 28MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT USING A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. DURING THE PROCEDURE UNIDENTIFIED MATERIAL WAS OBSERVED ATTACHED TO THE END OF THE DELIVERY SHEATH WHILE ATTEMPTING TO DEPLOY THE OCCLUDER. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 28MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER. 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 23224995 ↗
• DeathSep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WAS USED FOR A PROCEDURE. THE PATIENT HAS A PAST MEDICAL HISTORY OF CABG, BIOPROSTHETIC AVR, CEREBRAL ANEURYSM, AND ATRIAL FIBRILLATION. ON (B)(6) 2024, THE PATIENT PRESENTED TO THE HOSPITAL WITH STROKE SYMPTOMS. COMPUTED TOMOGRAPHY (CT) FOR LARGE VESSEL OCCLUSION WAS NEGATIVE. WITHIN 8 HOURS OF ADMISSION, THE PATIENT BECAME BRADYCARDIC WITH WORSENING NIH SCORE. REPEAT CT SHOWED NEW INTRACEREBRAL HEMORRHAGE. TRANEXAMIC ACID BOLUS WAS GIVEN AND ON (B)(6) 2024, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR ADMISSION. THE PATIENT RECEIVED MEDICATIONS AND MAINTAINED ABILITY TO SPEAK AND FOLLOW COMMANDS. ON (B)(6) 2024, THE PATIENT BEGAN TO DEVELOP RESPIRATORY FAILURE. THEREFORE, ON (B)(6) 2024, THE PATIENT WAS INTUBATED. "DESPITE ATTEMPTS MADE TO OPTIMIZE CLINICAL CONDITION," THE PATIENT CONTINUE TO FAIL. THE PATIENT DENIED TRACH AND ON (B)(6) 2024, TERMINAL EXTUBATING WAS PERFORMED; THE PATIENT PASSED SHORTLY AFTER EXTUBATING.

  Patient problems: Bradycardia; Intracranial Hemorrhage; Respiratory Insufficiency

  MAUDE report 23089961 ↗
• InjuryAug 15, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)6) 2025, AN 18MM AMPLATZER AMULET OCCLUDER WAS SUCCESSFULLY IMPLANTED USING A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. DURING A PROCEDURE PERFORMED UNDER CONSCIOUS SEDATION WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE), THE PATIENT PRESENTED WITH COMPLEX CARDIAC ANATOMY AND A PRE-PROCEDURAL PERICARDIAL EFFUSION MEASURING 1.7 MM. A PRE-PROCEDURAL COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A RELATIVELY LARGE LEFT ATRIAL APPENDAGE (LAA). WHILE THE OCCLUDER WAS BEING ADVANCED THROUGH THE DELIVERY SHEATH, THE PATIENT EXPERIENCED PREMATURE VENTRICULAR CONTRACTIONS (PVCS) AND REPORTED FEELING HOT, THOUGH WITHOUT CHEST PAIN. UPON INJECTING CONTRAST INTO THE LAA, A FAINT LEAK OF CONTRAST WAS OBSERVED EXITING THE APPENDAGE. AFTER DEVICE DEPLOYMENT, SUSPECTED AIR BUBBLES WERE SEEN IN THE AORTA VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE), PROMPTING A SWITCH TO TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND CONVERSION TO GENERAL ANESTHESIA. TEE IMAGING RULED OUT AORTIC COMPLICATIONS BUT CONFIRMED THE PRESENCE OF BUBBLES WITHIN THE PERICARDIAL EFFUSION, BUT WERE NOT INTRACARDIAC. A HEMATOMA WAS ALSO IDENTIFIED AND LOCATED BETWEEN THE AORTA AND THE LAA, EXTERNAL TO THE HEART. THE

  Patient problems: Air Embolism; Arrhythmia

  MAUDE report 22817060 ↗
• MalfunctionJul 24, 2025Difficult to Advance; Material Twisted/Bent; Material Split, Cut or Torn; Difficult to Advance; Material Twisted/Bent; Material Split, Cut or Torn

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22591724 ↗
• MalfunctionJul 18, 2025Difficult to Insert; Material Split, Cut or Torn; Difficult to Insert; Material Split, Cut or Torn

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541832 ↗
• MalfunctionJun 26, 2025Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn

  (B)(4) - VERITAS STUDY, PATIENT SITE ID: (B)(6). IT WAS REPORTED ON (B)(6) 2025 A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WAS SELECTED FOR A PROCEDURE. DURING THE PROCEDURE IT WAS NOTED THAT THE DILATOR OF THE DELIVERY SHEATH SPLIT WHILE ADVANCING THE DELIVERY SHEATH THROUGH THE NON-ABBOTT GUIDEWIRE THAT HAD KINKED. THE DELIVERY SHEATH WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS TO 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 22338418 ↗
• MalfunctionJun 17, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2025, A 14F AMPLATZER TORQVUE DELIVERY SYSTEM (DS) WAS SELECTED FOR USE IN AN IMPLANT PROCEDURE. AFTER THE DEVICE WAS BEING INTRODUCED, THE DILATOR HAD BECOME SPLIT. A NEW 14F AMPLATZER TORQVUE DS WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22241510 ↗
• MalfunctionMay 12, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2025, A 14F AMPLATZER TORQVUE 45X45 DELIVERY SYSTEM (DS) WAS SELECTED FOR USE IN AN IMPLANT PROCEDURE. DURING THE PROCEDURE, AFTER TRYING TO CROSS SEPTUM, WHEN THE SHEATH WAS REMOVED IT WAS NOTED THAT THE DILATOR SPLIT DUE TO AN UNKNOWN REASON. THE DEVICE WAS REPLACED WITH ANOTHER 14F AMPLATZER TORQVUE 45X45 DELIVERY SYSTEM (DS) TO RESOLVE THE EVENT. THE PHYSICIAN DOESN'T BELIEVE THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGH THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002055 ↗
• MalfunctionApr 10, 2025Product Quality Problem; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn; Product Quality Problem; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2025, A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WAS FOUND WITH BURRS AND CRACKS ON THE HEAD SECTION OF THE DELIVERY SHEATH TIP AFTER REMOVAL FROM DEVICE PACKAGING. THERE WAS NO REPORT OF ANY DAMAGE TO PACKAGING BOX DURING DEVICE PREPARATION. UPON DISCOVERY OF THE DAMAGE ON THE DELIVERY SHEATH, A DECISION WAS MADE TO REPLACE WITH A SECOND 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH TO CONTINUE THE PROCEDURE. THE PATIENT STATUS WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21821261 ↗
• DeathApr 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 20MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. DURING PROCEDURE, THE ACTIVATED CLOTTING LEVELS WERE 283S AND THE VENOUS ACCESS WAS UNEVENTFUL, UPON GETTING TRANSEPTAL THE PHYSICIAN FLOSSED THE SEPTUM 7 TIMES WITH THE AMPLATZER DELIVERY SHEATH OVER A GUIDEWIRE. THE PHYSICIAN THEN BROUGHT TORQVUE SHEATH INTO THE RIGHT ATRIUM AND PASSED ICE CATHETER INTO THE LEFT ATRIUM, ONCE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WAS IN LEFT ATRIUM A LARGE LEFT SIDED CIRCUMFERENTIAL PERICARDIAL EFFUSION WAS NOTED ON ICE. A CARDIAC TAMPONADE WAS ALSO PRESENT. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE PATIENT BUT, PATIENT LOST PULSES TWICE AND CARDIOPULMONARY RESUSCITATION (CPR) WAS DONE FOR APPROXIMATELY 6 MINUTES. THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PROBE WAS PASSED INTO PATIENTS ESOPHAGUS AND EFFUSION WAS NOTED WITH LITTLE TO NO PULSE. THEY CONFIRMED EFFUSION WAS COMING FROM A HOLE PUNCTURED IN THE LEFT ATRIAL APPENDAGE, PHYSICIAN DECIDED TO CONTINUE WITH AMULET IMPLANT IN ORDER TO TRY TO SEAL OFF EFFUSION. THE 20MM AMULET DEVICE WAS ATTEMPTED BUT RESULTED IN LEAK AROUND L

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 21798874 ↗
• MalfunctionApr 4, 2025Difficult to Insert; Material Split, Cut or Torn; Difficult to Insert; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2025, A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WAS SELECTED FOR PROCEDURE. IT WAS NOTED DURING PROCEDURE, THAT THE DILATOR TIP OF DELIVERY SHEATH BECAME DEFORMED WHEN ATTEMPTING TO INSERT IT OVER A NON-ABBOTT GUIDEWIRE BETWEEN THE LEVEL OF THE SKIN AND VENOTOMY. THE DECISION WAS MADE TO REMOVE THE 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AND REPLACE IT WITH ANOTHER ONE OF THE SAME SIZE. HOWEVER, IT WAS NOTED WHEN PASSING OVER THE NON-ABBOTT GUIDEWIRE THAT THE REPLACEMENT DELIVERY SHEATH WAS ALSO UNABLE TO BE INSERTED INTO THE PATIENT THROUGH THE VENOTOMY. THE DELIVERY SHEATH WAS REMOVED AND FOUND TO HAVE A SPLIT DILATOR TIP. BOTH DELIVERY SHEATHS MADE PATIENT CONTACT. THERE WAS NO REPORT OF THE PATIENT HAVING A TORTUOUS ANATOMY. THE DECISION WAS MADE TO DILATE THE VENOTOMY WITH AN UNKNOWN VASCULAR DILATOR SHEATH AND PREPARE ANOTHER 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS REPORTED. THE CAUSE OF THE DAMAGE TWO THE 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATHS ARE ATTRIBUTED TO THE NON-ABBOTT GUIDEWIRE. THE PATIENT WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774572 ↗
• MalfunctionApr 4, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WAS SELECTED FOR PROCEDURE. IT WAS NOTED DURING PROCEDURE, THAT THE DILATOR TIP OF DELIVERY SHEATH BECAME DEFORMED WHEN ATTEMPTING TO INSERT IT OVER A NON-ABBOTT GUIDEWIRE BETWEEN THE LEVEL OF THE SKIN AND VENOTOMY. THE DECISION WAS MADE TO REMOVE THE 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AND REPLACE IT WITH ANOTHER ONE OF THE SAME SIZE. HOWEVER, IT WAS NOTED WHEN PASSING OVER THE NON-ABBOTT GUIDEWIRE THAT THE REPLACEMENT DELIVERY SHEATH WAS ALSO UNABLE TO BE INSERTED INTO THE PATIENT THROUGH THE VENOTOMY. THE DELIVERY SHEATH WAS REMOVED AND FOUND TO HAVE A SPLIT DILATOR TIP. BOTH DELIVERY SHEATHS MADE PATIENT CONTACT. THERE WAS NO REPORT OF THE PATIENT HAVING A TORTUOUS ANATOMY. THE DECISION WAS MADE TO DILATE THE VENOTOMY WITH AN UNKNOWN VASCULAR DILATOR SHEATH AND PREPARE ANOTHER 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS REPORTED. THE CAUSE OF THE DAMAGE TWO BOTH THE 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATHS ARE ATTRIBUTED TO THE NON-ABBOTT GUIDEWIRE. THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774391 ↗
• DeathMar 20, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2025, AN AMPLATZER AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLUDER WAS CHOSEN FOR IMPLANTATION UTILIZING A 14F TORQVUE 45X45 DELIVERY SHEATH. DURING ADVANCEMENT OF THE DELIVERY SYSTEM, RESISTANCE WAS ENCOUNTERED AND ADVANCEMENT WAS STOPPED. ON FLUOROSCOPY, THE SHEATH WAS WRAPPED AROUND ITSELF AND KINKED SO THE DELIVERY SYSTEM WAS REMOVED AND REPLACED. A 18F GROIN SHEATH WAS PLACED AND THE REPLACEMENT 14F TORQVUE 45X45 DELIVERY SYSTEM WAS ADVANCED. THE DELIVERY SYSTEM EXPERIENCED RESISTANCE WHEN TRYING TO CROSS THE SEPTUM. THE DELIVERY SYSTEM WAS REMOVED AND THE SEPTUM WAS DILATED. THE DELIVERY SYSTEM WAS THEN ABLE TO CROSS THE SEPTUM AND ADVANCED TO THE LAA. BLOOD PRESSURE BECAME UNSTABLE SO THE CASE WAS ABORTED. NO EFFUSION OR GROIN COMPLICATIONS WERE OBSERVED. ONCE PATIENT WAS BROUGHT TO THE RECOVERY AREA BLOOD PRESSURE DROPPED. A HEMATOMA WAS NOTED IN GROIN AREA. MANUAL COMPRESSION WAS PERFORMED, AND THE PATIENT CODED AND DIED. IT IS BELIEVED THAT THE PATIENT HAD A BLEED AT THE GROIN SITE AND ENTERED CARDIOGENIC SHOCK DUE TO A LOW EJECTION FRACTION. THE CAUSE OF THE BLEED IS UNKNOWN AS AN ARTERIAL LINE HAD ALSO BEEN INSERTED.

  Patient problems: Cardiac Arrest; Hematoma; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 21654377 ↗
• MalfunctionMar 14, 2025Difficult to Insert; Material Split, Cut or Torn; Difficult to Insert; Material Split, Cut or Torn

  IT WAS REPORTED ON (B)(6) 2025 A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WAS SELECTED FOR A PROCEDURE. THE PATIENT'S LANDING ZONE WAS 22MM AND LEFT ATRIAL APPENDAGE (LAA) DEPTH WAS 14MM. DURING THE PROCEDURE IT WAS NOTED THAT THERE WAS RESISTANCE WHILE ATTEMPTING TO INSERT THE DELIVERY SHEATH INTO THE PATIENT ANATOMY. UPON INSERTION OF THE DELIVERY SHEATH INTO THE PATIENT'S GROIN, THE TIP OF THE DILATOR SPLIT. THE DELIVERY SHEATH WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. IT WAS NOTED THERE WAS ALSO RESISTANCE WHILE ATTEMPTING TO INSERT THE SECOND DELIVERY SHEATH INTO THE PATIENT ANATOMY. AFTER INSERTION OF THE DELIVERY SHEATH, RESISTANCE WAS OBSERVED WHILE ATTEMPTING TO ADVANCE THE DELIVERY SHEATH THROUGH THE PATIENT ANATOMY. THE TIP OF THE DILATOR ALSO SPLIT. THE SECOND DELIVERY SHEATH WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW THIRD DELIVERY SHEATH. THE AMULET WAS NOT IMPLANTED DUE TO LEFT ATRIAL APPENDAGE (LAA) BEING TOO LARGE FOR CLOSURE. THE PROCEDURE WAS ABORTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS DURING THE PROCEDURE. THERE WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607185 ↗