Sentrant™ SENSH1428W (UDI 00643169792586)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00643169792586), received between Aug 26, 2019 and Mar 21, 2024 — classified as 7 deaths, 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• DeathMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SENTRANT SHEATH WAS USED AS FOR PRE-DILATION DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE. IT WAS REPORTED DURING THE PROCEDURE, THE PHYSICIAN CONFIRMED THAT THERE WAS DISSECTION OF THE ASCENDING AORTA, THE PATIENT WENT INTO CARDIAC ARREST, CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. AFTER 40 MINUTES OF CPR, THE PATIENT SUBSEQUENTLY DIED.   NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS DUE TO A POSSIBLE ASCENDING AORTIC DISSECTION. IT WAS CONFIRMED THAT THE SENTRANT SHEATH WAS ONLY USED FOR PRE-DILATION AND DID NOT CONTRIBUTE TO THE DISSECTION.

  Patient problems: Cardiac Arrest; Vascular Dissection

  MAUDE report 18947969 ↗
• DeathJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SENTRANT SHEATH WAS USED AS A CONDUIT DURING THE IMPLANT OF A TRANSCATHETER VALVE. IT WAS REPORTED DURING THE PROCEDURE, THE SENTRANT SHEATH WAS USED BEFORE THE DELIVERY SYSTEM WAS INTRODUCED. THE VALVE WAS IMPLANTED AS PLANNED. IT WAS NOTED AFTER THE RELEASE OF THE PROSTHESIS, THE PATIENTS¿ BLOOD PRESSURE DROPPED AND THROUGH THE ECHOCARDIOGRAM IMAGES A PERICARDIAL EFFUSION WAS IDENTIFIED, IT WAS SUSPECTED A GUIDE WIRE INJURED THE PERICARDIUM. A PUNCTURE FOR DRAINAGE WAS PERFORMED, AFTER MANAGING TO STABILIZE THE PATIENT'S HEMODYNAMIC CONDITION AND THE PATIENT UNDERWENT AN INTERVENTION FOR SEPTAL CLOSURE. ON THE 14-DEC-2023. THE PATIENT CONDITION DETERIORATED AND THE PATIENT PASSED AWAY. PER THE PHYSICIAN THE SENTRANT SHEATH DID NOT CAUSE ANY HARM TO THE PATIENT. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT EXPIRED.

  Patient problems: Pericardial Effusion

  MAUDE report 18442422 ↗
• DeathJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SENTRANT SHEATH WAS USED AS A CONDUIT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE. IT WAS REPORTED DURING THE PROCEDURE, PRE-DILATION WAS CARRIED OUT WITH THE SENTRANT SHEATH AND A NON MDT DELIVERY SYSTEM WAS ADVANCED THROUGH THE RIGHT FEMORAL, PROSTHESIS RELEASED AT 5MM DEPTH AFTER 3 RECAPTURES . THE PATIENT HAD AN ABNORMAL ELECTROCARDIOGRAM (BAVT) AND WAS DEPENDENT ON A TEMPORARY TRANSVENOUS PACEMAKER. AFTER RELEASE, A MODERATE LEAK WAS NOTED AND POST-DILATION WAS PERFORMED WITH A NON MDT BALLOON. FINAL CONTROL WAS CARRIED OUT AND OK. THE PATIENTS BLOOD PRESSURE DROPPED AND CONNECTION TO THE TRANSVENOUS PACEMAKER WAS LOST. RIGHT VENTRICULAR PERFORATION AND CARDIAC TAMPONADE WERE IDENTIFIED ON THE ECHOCARDIOGRAM. PERICARDIAL DRAINAGE AND CARDIOPULMONARY RESUSCITATION MANEUVERS WERE PERFORMED. BUT WITHOUT SUCCESS AND THE PATIENT EXPIRED. PER THE PHYSICIAN THE SENTRANT SHEATH DID NOT CONTRIBUTE TO THE CARDIAC TAMPONADE, VENTRICULAR PERFORATION OR THE PATIENT DEATH. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 18442337 ↗
• DeathSep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SENTRANT SHEATH WAS USED AS A CONDUIT DURING AN TAVR PROCEDURE. IT WAS REPORTED ON 2 DAYS POST THE INDEX PROCEDURE THE PATIENT SUFFERED COMPLICATIONS. CPR WAS GIVEN HOWEVER THE PATIENT EXPIRED IN HOSPITAL DUE TO COMPLICATIONS. THE CAUSE OF THE COMPLICATIONS AND DEATH IS UNDETERMINED.

  Patient problems: Cardiac Arrest

  MAUDE report 17841912 ↗
• DeathApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SENTRANT SHEATH WAS USED IN A TAVR PROCEDURE WHERE A MEDTRONIC EVOLUT HEART VALVE WAS IMPLANTED. IT WAS REPORTED THAT DURING THE PROCEDURE, A AORTIC DISSECTION OCCURRED AFTER PRE-DILATION. THE PATIENT THEN EXPIRED DUE TO THE DISSECTED AORTA.  PER THE PHYSICIAN THE CAUSE OF THE DISSECTION WAS ANATOMY AND THE ASCENDING AORTA DILATED, BICUSPID VALVE.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Vascular Dissection

  MAUDE report 16775647 ↗
• DeathJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO SENTRANT SHEATHS WERE USED DURING AN AORTIC HEART VALVE PROCEDURE. IT WAS REPORTED DURING THE INDEX PROCEDURE, AFTER DISSECTION OF THE LEFT AXILLARY ARTERY, THE PHYSICIAN TRIED TO PROGRESS THE DELIVERY SYSTEM OF THE EVOLUT PRO BUT WAS UNSUCCESSFUL. AFTER PUNCTURE OF THE LEFT FEMORAL ARTERY AND ACCOMMODATING THE GUIDEWIRE, THE SENTRANT 14F WAS SUCCESSFULLY INTRODUCED. THE INTRODUCER WAS REMOVED HOWEVER, THE DELIVERY SYSTEM OF THE HEART VALVE COULD NOT THEN BE INTRODUCED. IT WAS NOTED THE INSERTION OF THE INTRODUCER WAS TO TEST THE CALIBER OF THE ACCESS, BECAUSE IF THE SENTRANT WERE SUCCESSFULLY INTRODUCED, THE DELIVERY SYSTEM WITH THE PROSTHESIS WOULD PROBABLY ALSO PROGRESS. IT WAS NOTED THAT THE MINIMUM DIAMETER OF THE ACCESS FEMORAL ARTERY WAS 4.2 X 6.4MM. A LEFT ANGIOPLASTY WAS PERFORMED WITH A 7X40MM BALLOON. THE DELIVERY SYSTEM WAS THEN INSERTED BUT WOULD NOT ADVANCE THROUGH THE ARTERY DUE TO PATIENT'S ANATOMY. AN ATTEMPT WAS MADE TO INSERT THE 18F SENTRANT BUT IT WAS NOT SUCCESSFUL. THERE WAS EVIDENCE OF A DISSECTION IN THE ILIAC AND LEFT FEMORAL ARTERY. COVERED STENTS WERE SUCCESSFULLY THEN IMPLANTED. PER THE PHYSICIAN THE CAUSE OF THE DIFFICULTY TO ADVANCE WAS ANATOMY RE

  Patient problems: Vascular Dissection

  MAUDE report 14641493 ↗
• MalfunctionAug 23, 2021Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  A SENTRANT SHEATH WAS ATTEMPTED TO BE USED AS AN ACCESSORY DEVICE FOR A UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE SHEATH STARTED LEAKING WHEN CATHETER WAS INSERTED. THE CATHETER WAS THEN REMOVED AND THE VALVE ASSEMBLY CAME OUT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12354936 ↗
• InjuryAug 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SENTRANT SHEATH WAS USED AS AN ACCESSORY DEVICE IN AN UNKNOWN TEVAR PROCEDURE IT WAS REPORTED THE ANGIO TAKEN AT THE END OF THE PROCEDURE SHOWED A TEAR IN THE RIGHT EXTERNAL ILIAC ARTERY. BALLOONING WAS PERFORMED FOLLOWED BY STENTING WITH NON MDT DEVICES. THE SITE ASSESSED THE EVENT AS HAVING A CAUSAL RELATIONSHIP TO THE SENTRANT SHEATH AND TO THE PROCEDURE. THE SPONSOR ASSESSED THE EVENT AS RELATED TO BOTH THE DEVICE AND THE PROCEDURE NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE

  Patient problems: Vascular Dissection

  MAUDE report 12352857 ↗
• MalfunctionJul 8, 2021Leak/Splash; Leak/Splash

  A SENTRANT SHEATH WAS USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, THERE APPEARED TO BE A LEAK FROM THE VALVE OF THE DEVICE. THE PHYSICIAN THEN PLACED A 9 FR SHEATH INSIDE THE 14 FR SENTRANT SHEATH AND THIS SOLVED THE PROBLEM. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS MOST LIKELY AND ISSUE WITH THE VALVE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12133996 ↗
• DeathMar 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SENTRANT HYDRO SHEATH WAS USED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PATIENT HAD BLEEDING IN THE LEFT FEMORAL REGION AFTER REMOVAL OF THE DELIVERY CATHETER SYSTEM. AN OPEN SUTURE WAS MADE, BUT IT CONTAINED NO BLEEDING, THE PATIENT WAS TAKEN TO THE SURGERY BLOCK. PATIENT DIED FEW HOURS LATER. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO A VASCULAR DISEASE. THE CAUSE OF DEATH WAS DUE TO ARTERIAL LACERATION OF THE LEFT FEMORAL ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED. PATIENT EXPIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 11420447 ↗
• MalfunctionSep 15, 2020Material Deformation; Material Deformation

  A SENTRANT SHEATH WAS INTENDED TO BE USED AS AN ACCESSORY DEVICE IN AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE SHEATH HUB AND VALVES PULLED APART WHILE THE DEVICE WAS BEING PREPPED FOR THE CASE. A REPLACEMENT SHEATH WAS USED TO IN THE PROCEDURE INSTEAD. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10533540 ↗
• MalfunctionMar 27, 2020Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  A SENTRANT SHEATH WAS USED IN THE ENDOVASCULAR TREATMENT OF A PATIENT. IT WAS REPORTED THAT DURING THE PROCEDURE AFTER SHEATH INSERTION AND DILATOR REMOVAL THERE WAS DIFFICULTY DRAWING BACK FROM THE SIDEPORT. IT WAS REPORTED THAT A KINK WAS NOTED IN THE PROXIMAL PORTION OF THE SIDEPORT (IN THE CLEAR TUBING). THERE WAS NO INJURY TO THE PATIENT AND IT WAS POSSIBLE TO DRAW SLOWLY FROM THE SIDE PORT. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS BELIEVED TO BE DEVICE RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9888043 ↗
• MalfunctionJan 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  A SENTRANT SHEATH WAS INTENDED TO BE USED IN THE ENDOVASCULAR TREATMENT OF A PATIENT. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE SHEATH WAS ADVANCED BUT THE DILATOR WAS ATTEMPTED TO BE REMOVED , THE HEMOSTATIC VALVE CAME WITH IT. THIS SHEATH WAS THEN REMOVED AND REPLACED WITH A NEW SENTRANT SHEATH OF THE SAME LOT NUMBER WITHOUT ANY ISSUES ENCOUNTERED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS THE HEMOSTATIC VALVE NOT BEING CONNECTED TO THE REST OF THE SHEATH. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9563315 ↗
• MalfunctionAug 26, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A SENTRANT SHEATH WAS USED AS AN ACCESSORY DEVICE FOR THE ENDOVASCULAR TREATMENT OF A PATIENT. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THERE WAS BLOOD LEAKING FROM THE VALVE. THE DEVICE WAS EXCHANGED FOR ANOTHER SHEATH AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8930626 ↗