iSLEEVE™ H74939349140Recalls & reported problems

Summary

The FDA's MAUDE database contains 243 adverse event reports that list this exact device (DI 08714729950660), received between Aug 15, 2018 and May 27, 2025 — classified as 12 deaths, 87 injuries, 144 malfunctions.

The most frequently reported specific device problem is “Break” (73 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 20, 2024Open, Classified

   Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.

   Z-1390-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 243 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TIP SPLIT IN A MANNER CREATING A SHARP EDGE OCCURRED. DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE VASCULAR ACCESS WAS OBTAINED VIA A MILDLY CALCIFIED AND MILDLY TORTUOUS TRANSFEMORAL APPROACH. A 14F ISLEEVE INTRODUCER SHEATH WAS PLACED AND A SAFARI2 GUIDEWIRE WAS ADVANCED INTO POSITION. AN ACURATE PRIME DELIVERY SYSTEM WITH LOADED ACURATE PRIME VALVE WAS ADVANCED AND REMOVED THROUGH THE 14F ISLEEVE INTRODUCER SHEATH WITH NO RESISTANCE NOTED. AT THE CONCLUSION OF THE PROCEDURE, AFTER REMOVAL FROM THE PATIENT, IT WAS OBSERVED THE RADIOPAQUE TIP OF THE 14F ISLEEVE INTRODUCER SHEATH WAS SPLIT IN AN ATYPICAL MANNER CREATING A SHARP EDGE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090216 ↗
• DeathMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL TRAUMA AND PATIENT DEATH OCCURRED. THE PATIENT EXPERIENCED WORSENING COUGH AND GENERAL WEAKNESS AND WAS ADMITTED TO THE HOSPITAL FOR HEART FAILURE MANAGEMENT. IMAGING IDENTIFIED BILATERAL PLEURAL EFFUSION AND PNEUMONIA. TWO (2) DAYS POST HOSPITAL ADMITTANCE, TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) SHOWED SEVERE AORTIC STENOSIS WITH AN EJECTION FRACTION OF 52 PERFECT. NINE (9) DAYS POST HOSPITAL ADMITTANCE A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WAS PERFORMED. VASCULAR ACCESS WAS OBTAINED VIA A MILDLY TORTUOUS TRANSFEMORAL APPROACH. THE NATIVE AORTIC ANNULUS MEASURED 24.6MM IN DIAMETER. A 14F ISLEEVE INTRODUCER SHEATH WAS PLACED AND SAFARI2 GUIDEWIRE WAS ADVANCED INTO POSITION. BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH TWO (2) INFLATIONS OF A 23MM NON-BOSTON SCIENTIFIC (BSC) BALLOON CATHETER. AN ACURATE NEO2 VALVE SIZE MEDIUM WAS PREPARED AND LOADED ONTO AN ACURATE NEO2 TRANSFEMORAL (TF) DELIVERY SYSTEM (DS). THE ACURATE NEO2 DS WAS ADVANCED INTO POSITION, COMMISSURAL ALIGNMENT WAS ACHIEVED, AND THE ACURATE NEO2 VALVE WAS IMPLANTED AT THE INTENDED LOCATION. POST-DILATATION BAV WAS PERFORMED WITH ONE (1) INFLATION OF A NON-BSC BA

  Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels; Thrombosis/Thrombus

  MAUDE report 22005938 ↗
• MalfunctionMay 8, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. A 14F ISLEEVE INTRODUCER SHEATH WAS USED DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. FEMORAL ACCESS WAS OBTAINED VIA THE MILDLY TORTUOUS, NON-CALCIFIED, RIGHT FEMORAL ARTERY WITH A DIAMETER MEASURING 5.6MM. THE 14F ISLEEVE INTRODUCER SHEATH WAS PLACED IN THE FEMORAL ARTERY. THE TAVR PROCEDURE WAS SUCCESSFULLY PERFORMED. DURING REMOVAL OF THE 14F ISLEEVE INTRODUCER SHEATH FROM THE PATIENT IT WAS DISCOVERED A FRAGMENT OF THE RADIOPAQUE TIP HAD DETACHED. THE DETACHED TIP FRAGMENT WAS LOCATED UNDER THE SKIN NEAR THE FEMORAL PUNCTURE SITE. THE OPERATORS REMOVED THE DETACHED TIP FRAGMENT USING SURGICAL FORCEPS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985558 ↗
• MalfunctionMay 7, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATYPICAL TIP SPLIT OCCURRED. A TRANSCATHETER AORTIC VALVE IMPLANT (TAVI) PROCEDURE WAS PERFORMED WITH USE OF AN 14F ISLEEVE INTRODUCER SHEATH FOR FEMORAL ACCESS. DURING THE TAVI AN ACURATE PRIME VALVE AND DELIVERY SYSTEM WERE ADVANCED THROUGH THE 14F ISLEEVE INTRODUCER SHEATH. AT THE CONCLUSION OF THE TAVI, AFTER 14F ISLEEVE INTRODUCER SHEATH WITHDRAWAL, THE PHYSICIAN OBSERVED THE TIP OF THE 14F ISLEEVE INTRODUCER SHEATH WAS SPLIT UNCOMMONLY. THE TIP WAS SPLIT ONLY AT ONE POINT, CREATING AN ANCHOR SHAPE WHICH THE PHYSICIAN FELT COULD BE DANGEROUS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21980224 ↗
• MalfunctionMay 6, 2025Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE PATIENT'S ANATOMY CONTAINED A NATIVE AORTIC ANNULUS MEASURING 27.5MM IN DIAMETER WITH MODERATE TO SEVERE CALCIFICATION. THE LEFT CORONARY ARTERY (LCA) DISTANCE MEASURED 8.9MM. THE FEMORAL ARTERIES CONTAINED EXTREME TORTUOSITY. AT THE BEGINNING OF THE PROCEDURE, THE PATIENT HAD A BLOOD PRESSURE UNDER 70MMHG AND AN EJECTION FRACTION <30%. THE LCA WAS PROTECTED. VASCULAR ACCESS WAS OBTAINED VIA A TRANSFEMORAL APPROACH. A 14F ISLEEVE INTRODUCER SHEATH WAS ADVANCED. A SAFARI2 GUIDEWIRE WAS ADVANCED AND POSITIONED IN THE LEFT VENTRICLE. BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH ONE INFLATION OF A 24MM NON-BOSTON SCIENTIFIC (BSC) BALLOON CATHETER. COMMISSURAL ALIGNMENT WAS PERFORMED. A 29MM ACURATE PRIME VALVE WAS PREPARED AND LOADED ONTO AN ACURATE PRIME DELIVERY SYSTEM (DS). THE ACURATE PRIME DS WAS ADVANCED INTO POSITION. THE 29MM ACURATE PRIME VALVE WAS DEPLOYED, MOVED UP AND WAS UNDER EXPANDED. A 26MM NON-BSC VALVE WAS PREPARED AND DELIVERED THROUGH THE 14F ISLEEVE INTRODUCER SHEATH. ONCE AT THE LEVEL OF THE DESCENDING AORTA, IT WAS OBSERVED THAT PART OF THE 14F ISLEEVE INTRODUCER SHEATH TIP CHIPPED AND WAS ATTACHED TO THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21972103 ↗
• MalfunctionApr 22, 2025Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SHEATH LINER TEAR OCCURRED. A 14F ISLEEVE INTRODUCER SHEATH WAS USED DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. FEMORAL ACCESS WAS OBTAINED VIA THE MILDLY CALCIFIED, MILDLY STENOTIC, MODERATELY TORTUOUS FEMORAL ARTERY. A SAFARI2 GUIDEWIRE, 20MM NON-BOSTON SCIENTIFIC (BSC) PRE-DILATATION BALLOON CATHETER, AND 23-25MM ACURATE PRIME DELIVERY SYSTEM WERE PASSED THROUGH THE 14F ISLEEVE INTRODUCER SHEATH WITHOUT ISSUE. THE TAVR PROCEDURE WAS SUCCESSFULLY COMPLETED. AT THE CONCLUSION OF THE PROCEDURE DIFFICULTY WAS ENCOUNTERED REMOVING THE 14F ISLEEVE INTRODUCER SHEATH. UPON REMOVAL A TEAR THROUGH THE SHEATH LINER AT THE DISTAL END WAS OBSERVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882158 ↗
• MalfunctionApr 22, 2025Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SHEATH LINER TEAR OCCURRED. A 14F ISLEEVE INTRODUCER SHEATH WAS USED DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. FEMORAL ACCESS WAS OBTAINED VIA THE MILDLY CALCIFIED, MILDLY STENOTIC, MILDLY TORTUOUS FEMORAL ARTERY. A SAFARI2 GUIDEWIRE, 22MM NON-BOSTON SCIENTIFIC (BSC) PRE-DILATATION BALLOON CATHETER, AND 27-29MM ACURATE PRIME DELIVERY SYSTEM WERE PASSED THROUGH THE 14F ISLEEVE INTRODUCER SHEATH WITHOUT ISSUE. THE TAVR PROCEDURE WAS SUCCESSFULLY COMPLETED. AT THE CONCLUSION OF THE PROCEDURE DIFFICULTY WAS ENCOUNTERED REMOVING THE 14F ISLEEVE INTRODUCER SHEATH. UPON REMOVAL A TEAR THROUGH THE SHEATH LINER AT THE DISTAL END WAS OBSERVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882153 ↗
• MalfunctionApr 22, 2025Break; Failure to Advance; Material Integrity Problem; Break; Failure to Advance; Material Integrity Problem

  IT WAS REPORTED THAT A SHEATH LINER TEAR OCCURRED. A 14F ISLEEVE INTRODUCER SHEATH WAS USED DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. FEMORAL ACCESS WAS OBTAINED VIA THE MILDLY TORTUOUS FEMORAL ARTERY. A SAFARI2 GUIDEWIRE AND UNKNOWN PRE-DILATATION BALLOON CATHETER WERE ADVANCED THROUGH THE 14F ISLEEVE INTRODUCER SHEATH. DIFFICULTY WAS ENCOUNTERED REMOVING THE BALLOON CATHETER THROUGH THE TIP OF THE 14F ISLEEVE INTRODUCER SHEATH. THE BALLOON CATHETER WAS INFLATED, DEFLATED, AND A SECOND ATTEMPT AT REMOVAL WAS UNSUCCESSFUL. THE 14F ISLEEVE INTRODUCER SHEATH AND BALLOON CATHETER WERE REMOVED AS A UNIT AND A SHEATH LINER TEAR AND TIP DAMAGE WERE NOTED. A NEW 14F ISLEEVE INTRODUCER SHEATH WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881773 ↗
• MalfunctionApr 14, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT A TIP TEAR RESULTING IN A PARTIALLY DETACHED FLAP AND A LINER TEAR OCCURRED. A 14F ISLEEVE INTRODUCER SHEATH WAS USED DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. AN UNKNOWN GUIDEWIRE, UNKNOWN PIGTAIL CATHETER, AND ACURATE NEO2 TRANSFEMORAL (TF) DELIVERY SYSTEM (DS) WERE ADVANCED AND REMOVED THROUGH THE 14F ISLEEVE INTRODUCER SHEATH WITH NO RESISTANCE NOTED. AT THE CONCLUSION OF THE PROCEDURE, AFTER REMOVAL FROM THE PATIENT, IT WAS OBSERVED THE LINER OF THE 14F ISLEEVE INTRODUCER SHEATH WAS TORN AND THE TIP OF THE 14F ISLEEVE INTRODUCER SHEATH WAS TORN IN AN ATYPICAL MANNER WITH A PARTIALLY DETACHED FLAP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21836637 ↗
• MalfunctionApr 14, 2025Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT AN ATYPICAL TIP TEAR OCCURRED. A 14F ISLEEVE INTRODUCER SHEATH WAS USED DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE 14F ISLEEVE INTRODUCER SHEATH WAS PLACED IN THE MODERATELY TORTUOUS RIGHT FEMORAL ARTERY WHICH HAD A DIAMETER OF 7MM. A 20MM NON-BOSTON SCIENTIFIC BALLOON AORTIC VALVULOPLASTY BALLOON CATHETER AND ACURATE NEO2 TRANSFEMORAL DELIVERY SYSTEM WITH ACURATE NEO2 VALVE WERE ADVANCED THROUGH THE 14F ISLEEVE INTRODUCER SHEATH. AT THE CONCLUSION OF THE PROCEDURE RESISTANCE WAS ENCOUNTERED REMOVING THE 14F ISLEEVE INTRODUCER SHEATH. AFTER REMOVAL IT WAS OBSERVED THE TIP OF THE 14F ISLEEVE INTRODUCER SHEATH WAS HAD TORN IN AN ATYPICAL MANNER WITH A PARTIALLY DETACHED FLAP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21836607 ↗
• MalfunctionApr 8, 2025Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT AN ATYPICAL TIP TEAR OCCURRED. A 14F ISLEEVE INTRODUCER SHEATH WAS USED DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE 14F ISLEEVE INTRODUCER SHEATH WAS PLACED IN THE MILDLY STENOTIC, MILDLY CALCIFIED, MILDLY TORTUOUS FEMORAL ARTERY. A BALLOON AORTIC VALVULOPLASTY (BAV) BALLOON CATHETER, AN UNKNOWN MANUFACTURER'S VALVE DELIVERY SYSTEM, AND A POST-DILATATION BAV BALLOON CATHETER WERE PASSED THROUGH THE 14F ISLEEVE INTRODUCER SHEATH. AT THE CONCLUSION OF THE PROCEDURE DURING REMOVAL OF THE 14F ISLEEVE INTRODUCER SHEATH, RESISTANCE WAS ENCOUNTERED. AFTER REMOVAL FROM THE PATIENT IT WAS OBSERVED THE TIP OF THE 14F ISLEEVE INTRODUCER SHEATH WAS TORN IN AN ATYPICAL MANNER WITH A PARTIALLY DETACHED FLAP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21801139 ↗
• InjuryApr 3, 2025Difficult to Remove; Defective Device; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL LACERATION OCCURRED. DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE VASCULAR ACCESS WAS OBTAINED VIA A MILDLY CALCIFIED, MILDLY TORTUOUS, SEVERELY STENOTIC TRANSFEMORAL APPROACH. THE NATIVE AORTIC ANNULUS MEASURED 22.5MM IN DIAMETER. A 14F ISLEEVE INTRODUCER SHEATH WAS PLACED AND SAFARI2 GUIDEWIRE WAS ADVANCED INTO POSITION. BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH ONE (1) INFLATION OF A 20MM NON-BOSTON SCIENTIFIC (BSC) BALLOON CATHETER. AN ACURATE NEO2 VALVE SIZE MEDIUM WAS PREPARED AND LOADED ONTO AN ACURATE NEO2 TRANSFEMORAL (TF) DELIVERY SYSTEM (DS). THE ACURATE NEO2 TF DS WAS ADVANCED INTO POSITION, COMMISSURAL ALIGNMENT WAS ACHIEVED, AND THE ACURATE NEO2 VALVE WAS SUCCESSFULLY IMPLANTED AT THE INTENDED LOCATION. DURING REMOVAL OF THE ACURATE NEO2 TF DS TENSION WAS NOTED AND ANGIOGRAPHY REVEALED THE ACURATE NEO2 TF DS WAS STUCK AT THE TIP OF THE 14F ISLEEVE INTRODUCER SHEATH CAUSING THE INTRODUCER SHEATH TO BE DEFORMED. THE 14F ISLEEVE INTRODUCER AND ACURATE NEO2 TF DS WERE REMOVED TOGETHER AS A UNIT AND A NON-BSC DRY SEAL SHEATH WAS PLACED. AFTER REMOVAL OF THE 14F ISLEEVE INTRODUCER SHEATH AND ACURATE NEO2 TF DS A VE

  Patient problems: Laceration(s)

  MAUDE report 21763558 ↗
• MalfunctionMar 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A DEVICE FRAGMENT DETACHMENT OCCURRED. DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE VASCULAR ACCESS WAS OBTAINED VIA A MILDLY TORTUOUS TRANSFEMORAL APPROACH. THE MODERATELY CALCIFIED NATIVE AORTIC ANNULUS MEASURED 24.3MM IN DIAMETER. A 14F ISLEEVE INTRODUCER SHEATH WAS PLACED AND SAFARI2 GUIDEWIRE WAS ADVANCED INTO POSITION. BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH ONE (1) INFLATION OF A 23MM NON-BOSTON SCIENTIFIC (BSC) BALLOON CATHETER. A 25MM ACURATE PRIME VALVE WAS PREPARED AND LOADED ONTO AN ACURATE PRIME DELIVERY SYSTEM (DS). THE ACURATE PRIME DS WAS ADVANCED INTO POSITION, COMMISSURAL ALIGNMENT WAS ACHIEVED, AND INITIAL STAGE OF VALVE RELEASE WAS PERFORMED. AFTER THE INITIAL STAGE OF VALVE RELEASE, THE ACURATE PRIME VALVE WAS IN A SLIGHTLY HIGH POSITION RELATIVE TO THE NATIVE AORTIC ANNULUS. THE OPERATORS PUSHED ON THE ACURATE PRIME DS WHICH CORRECTED THE POSITION OF THE ACURATE PRIME VALVE. RAPID PACING WAS INITIATED, THE FINAL STAGE OF VALVE RELEASE WAS PERFORMED, AND ACURATE PRIME VALVE EMBOLIZED AORTICALLY. A 23MM NON-BSC VALVE WAS PREPARED FOR A VALVE-IN-VALVE PROCEDURE. THE 23MM NON-BSC VALVE SYSTEM WAS ADVANCED THRO

  Patient problems: Foreign Body In Patient

  MAUDE report 21691006 ↗
• MalfunctionMar 13, 2025Difficult to Remove; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ATYPICAL TIP TEAR OCCURRED. A 14F ISLEEVE INTRODUCER SHEATH WAS USED DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE 14F ISLEEVE INTRODUCER SHEATH WAS PLACED IN THE MILDLY CALCIFIED, MILDLY TORTUOUS FEMORAL ARTERY. AT THE CONCLUSION OF THE PROCEDURE DURING REMOVAL OF THE 14F ISLEEVE INTRODUCER SHEATH, RESISTANCE WAS ENCOUNTERED. AFTER REMOVAL FROM THE PATIENT IT WAS OBSERVED THE TIP OF THE 14F ISLEEVE INTRODUCER SHEATH WAS HAD TORN IN AN ATYPICAL MANNER WITH A PARTIALLY DETACHED FLAP WHICH RESULTED IN VESSEL BLEEDING. THE ATYPICAL DAMAGE TO THE 14F ISLEEVE TIP WAS SUSPECTED TO HAVE BEEN CAUSED BY A 28MM NON-BOSTON SCIENTIFIC BALLOON CATHETER PASSING THROUGH THE 14F ISLEEVE INTRODUCER SHEATH. PRESSURE WAS APPLIED IN RESPONSE TO THE VESSEL BLEEDING AND NO FURTHER INTERVENTIONS WERE REQUIRED. THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21599001 ↗
• MalfunctionMar 3, 2025Detachment of Device or Device Component; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. A 14F ISLEEVE INTRODUCER SHEATH WAS USED DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE 14F ISLEEVE INTRODUCER SHEATH WAS PLACED IN THE MILDLY CALCIFIED, MILDLY STENOTIC, AND MILDLY TORTUOUS FEMORAL ARTERY. AN ACURATE PRIME DELIVERY SYSTEM WITH A LOADED 23MM ACURATE PRIME VALVE WAS ADVANCED. THE 23MM ACURATE PRIME VALVE WAS SUCCESSFULLY IMPLANTED. THE OPERATOR REINTRODUCED THE 14 ISLEEVE INTRODUCER SHEATH DILATOR, THE NON-BOSTON SCIENTIFIC (BSC) SUTURE-MEDIATED CLOSURE DEVICE WAS CLOSED, AND THE 14F ISLEEVE INTRODUCER SHEATH WAS REMOVED. UPON REMOVAL FROM THE PATIENT IT WAS DISCOVERED A TIP FRAGMENT OF THE 14F ISLEEVE INTRODUCER SHEATH HAD DETACHED AND REMAINED IN THE PATIENT ANATOMY. CONTRAST ASSESSMENT CONFIRMED THE TIP FRAGMENT WAS IN THE PATIENT'S LEG NEAR THE FEMORAL PUNCTURE SITE. THE DECISION WAS MADE TO LEAVE THE TIP FRAGMENT IN PLACE. ADDITIONAL DOPPLER IMAGING PERFORMED ONE (1) DAY POST INDEX PROCEDURE CONFIRMED THE TIP FRAGMENT WAS EXTRA-VASCULAR. THE PHYSICIAN SUSPECTED THE 14F ISLEEVE INTRODUCER SHEATH TIP DETACHMENT WAS CAUSED BY THE NON-BSC CLOSURE DEVICE. THE PATIENT RECOVERED AND WAS DISCHARGED

  Patient problems: Foreign Body In Patient

  MAUDE report 21510384 ↗
• MalfunctionFeb 21, 2025Break; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A SHEATH LINER TEAR OCCURRED. DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE VASCULAR ACCESS WAS OBTAINED VIA A SEVERELY CALCIFIED, MODERATELY TORTUOUS, MODERATELY STENOTIC TRANSFEMORAL APPROACH. AN ATTEMPT WAS MADE TO ADVANCE A 14F ISLEEVE INTRODUCER SHEATH AND DIFFICULTY WAS ENCOUNTERED DUE TO THE FEMORAL CALCIFICATIONS AND TORTUOSITY. UPON REMOVAL, THE 14F ISLEEVE INTRODUCER SHEATH WAS OBSERVED TO BE COMPRESSED AND NEAR THE TIP OF THE DEVICE A TEAR THROUGH THE SHEATH LINER INCONSISTENT WITH THE EXPECTED SEAM EXPANSION WAS IDENTIFIED. THE FEMORAL ARTERY WAS DILATED WITH AN UNKNOWN 16F INTRODUCER SHEATH AND A NEW 14F ISLEEVE INTRODUCER SHEATH WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21439430 ↗
• InjuryJan 30, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT AN ATYPICAL TIP TEAR OCCURRED. PROCEDURE SUMMARY: A 14F ISLEEVE INTRODUCER SHEATH WAS USED DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. AT THE CONCLUSION OF THE PROCEDURE WHEN THE 14F ISLEEVE INTRODUCER SHEATH WAS REMOVED BLEEDING AT THE FEMORAL ACCESS SITE OCCURRED. A SMALL FEMORAL ARTERY DISSECTION WAS SUSPECTED. A NEW DILATOR AND CLOSURE DEVICE WERE PLACED, PRESSURE WAS APPLIED, AND FLUOROSCOPY SHOWED THE BLEEDING RESOLVED. WHEN THE 14F ISLEEVE INTRODUCER SHEATH WAS REMOVED FROM THE PATIENT AN ATYPICAL TEAR AT THE TIP OF THE DEVICE WAS IDENTIFIED WITH A PARTIALLY DETACHED FLAP. PATIENT STATUS: THE PATIENT FULLY RECOVERED AND WAS DISCHARGED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Vascular Dissection

  MAUDE report 21277610 ↗
• InjuryJan 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. PROCEDURE SUMMARY. A 14F ISLEEVE INTRODUCER SHEATH WAS USED DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE 14F ISLEEVE INTRODUCER SHEATH WAS PLACED AND A 27MM NON-BOSTON SCIENTIFIC (BSC) TAVR DELIVERY SYSTEM WAS ADVANCED. AFTER THE NON-BSC DELIVERY SYSTEM HAD PASSED THROUGH THE 14F ISLEEVE INTRODUCER SHEATH IT WAS OBSERVED THE TIP OF THE ISLEEVE HAD DETACHED. THE 27MM NON-BSC DELIVERY SYSTEM WAS WITHDRAWN. THE DETACHED 14F ISLEEVE INTRODUCER SHEATH TIP WAS SNARED AND REMOVED FROM THE PATIENT. THE 27MM NON-BSC DELIVERY SYSTEM WAS READVANCED THROUGH THE 14F ISLEEVE INTRODUCER SHEATH. THE 27MM NON-BSC VALVE WAS SUCCESSFULLY IMPLANTED AND THE PROCEDURE COMPLETED. PATIENT STATUS NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT HAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21233646 ↗
• MalfunctionNov 14, 2024Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATYPICAL TIP DAMAGE OCCURRED. THE PATIENT'S ILIOFEMORAL ANATOMY CONTAINED MODERATE TORTUOSITY AND SEVERE CALCIFICATION. VASCULAR ACCESS WAS OBTAINED VIA A RIGHT-SIDED TRANSFEMORAL APPROACH. A 14F ISLEEVE INTRODUCER SHEATH WAS ADVANCED. AN ACURATE NEO2 VALVE SYSTEM WAS ADVANCED THROUGH THE 14F ISLEEVE INTRODUCER SHEATH AND SUCCESSFULLY IMPLANTED IN THE INTENDED LOCATION. WHEN CLOSING FEMORAL ACCESS AND RETRIEVING THE 14F ISLEEVE INTRODUCER SHEATH THE PHYSICIAN NOTED THAT THE TIP OF THE 14F ISLEEVE INTRODUCER SHEATH WAS RIPPED AND SIGNIFICANTLY MORE FLARED THAN EXPECTED. THE 14F ISLEEVE INTRODUCER SHEATH WAS SUCCESSFULLY REMOVED USING THE DILATOR. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683904 ↗
• MalfunctionNov 13, 2024Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ATYPICAL TIP TEAR OCCURRED. PROCEDURE SUMMARY A 14F ISLEEVE INTRODUCER SHEATH WAS USED DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE FEMORAL VASCULATURE WAS MILDLY STENOSED, MILDLY CALCIFIED AND MILDLY TORTUOUS. A NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE WAS PLACED. BALLOON AORTIC VALVULOPLASTY WAS PERFORMED WITH A 20MM NON-BSC BALLOON CATHETER. A 23MM ACCURATE PRIME WAS PREPARED AND LOADED ONTO AN ACCURATE PRIME DELIVERY SYSTEM (DS). THE ACCURATE PRIME DS WAS ADVANCED INTO POSITION. THE 23MM ACCURATE PRIME VALVE WAS IMPLANTED TO TREAT THE NATIVE AORTIC ANNULUS. POST DILATATION WAS PERFORMED WITH A 20MM NON-BSC BALLOON CATHETER. AT THE CONCLUSION OF THE PROCEDURE WHEN THE 14F ISLEEVE INTRODUCER SHEATH WAS REMOVED, AN ATYPICAL TEAR IN THE 14 ISLEEVE TIP WAS IDENTIFIED. THE 14F ISLEEVE TIP HAD A PARTIALLY DETACHED FLAP. PATIENT STATUS NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678079 ↗
• MalfunctionNov 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. THE PATIENT'S NATIVE AORTIC ANNULUS MEASURED 22.7MM IN DIAMETER WITH MODERATE CALCIFICATION. THE PATIENT'S ANATOMY CONTAINED A HORIZONTAL AORTA. VASCULAR ACCESS WAS OBTAINED VIA A TRANSFEMORAL APPROACH. A 14F ISLEEVE INTRODUCER SHEATH WAS ADVANCED. A SIZE SMALL SAFARI2 GUIDEWIRE WAS ADVANCED AND POSITIONED. BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED EFFECTIVELY WITH A 22MM NON-BOSTON SCIENTIFIC (BSC) BALLOON CATHETER. A THREE-CUSP VIEW WAS OBTAINED. A SIZE MEDIUM ACURATE NEO2 VALVE WAS PREPARED AND LOADED ONTO AN ACURATE NEO2 TRANSFEMORAL (TF) DELIVERY SYSTEM (DS). THE ACURATE NEO2 TF DS WAS ADVANCED INTO POSITION. COMMISSURAL ALIGNMENT WAS SUCCESSFULLY PERFORMED. THE POSITIONING WAS CHECKED WITH CONTRAST. SLOW OPENING OF KNOB ONE FOR INITIAL RELEASE WAS PERFORMED. AFTER INITIAL RELEASE STEP ONE, CONTRAST WAS INJECTED AND THE SIZE MEDIUM ACURATE NEO2 VALVE WAS POSITIONED TOO HIGH. THE PHYSICIAN REPOSITIONED TO THE CORRECT HEIGHT. INITIAL RELEASE STEP TWO WAS PERFORMED, CONTRAST WAS INJECTED, AND THE POSITION OF THE SIZE MEDIUM ACURATE NEO2 VALVE WAS ASSESSED TO BE GOOD. SHORTLY BEFORE FINAL RELEASE, IT WAS OBSERVED THAT THE ACU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20677807 ↗
• DeathOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL DISSECTION AND PATIENT DEATH OCCURRED. DURING A COMPLEX TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, VASCULAR ACCESS WAS OBTAINED VIA A TRANSFEMORAL APPROACH WITH A MINIMUM FEMORAL ARTERY DIAMETER OF 4.7MM. THE MILDLY CALCIFIED NATIVE AORTIC ANNULUS MEASURED 20.6MM IN DIAMETER. A 14F ISLEEVE INTRODUCER SHEATH WAS PLACED AND SAFARI2 GUIDEWIRE WAS ADVANCED INTO POSITION. BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH ONE (1) INFLATION OF A 20MM NON-BOSTON SCIENTIFIC (BSC) BALLOON CATHETER. A SIZE SMALL ACURATE NEO2 VALVE WAS PREPARED AND LOADED ONTO AN ACURATE NEO2 TRANSFEMORAL (TF) DELIVERY SYSTEM (DS). THE ACURATE NEO2 TF DS WAS ADVANCED INTO POSITION, COMMISSURAL ALIGNMENT WAS ACHIEVED, AND THE ACURATE NEO2 VALVE WAS RELEASED. THE AORTIC GRADIENT POST IMPLANT WAS 5MMHG. AFTER IMPLANT OF THE ACURATE NEO2 VALVE WHEN THE 14F ISLEEVE INTRODUCER SHEATH WAS REMOVED A DISSECTION OF THE ILIAC ARTERY WAS IDENTIFIED. THREE (3) NON-BSC COATED STENTS WERE IMPLANTED. THE PATIENT EXPERIENCED SEVERE BLOOD LOSS. ONE (1) DAY POST IMPLANT PROCEDURE THE PATIENT DIED. THE OFFICIAL CAUSE OF DEATH WAS VASCULAR COMPLICATIONS. IT WAS FURTHER REPORTED THE CAU

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypovolemic Shock; Vascular Dissection

  MAUDE report 20346812 ↗
• MalfunctionSep 25, 2024Defective Device; Difficult to Advance; Defective Device; Difficult to Advance

  IT WAS REPORTED THAT DIFFICULT TO ADVANCE OCCURRED. A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE WAS BEING PERFORMED UTILIZING A 14F ISLEEVE INTRODUCER SHEATH FOR FEMORAL ACCESS. WHILE TRYING TO ADVANCE THE 14F ISLEEVE INTRODUCER SHEATH, A LOT OF RESISTANCE WAS ENCOUNTERED AT THE ILIAC ARTERY AS THERE WAS A TIGHT CURVE IN THE ANATOMY. THE 14F ISLEEVE INTRODUCER SHEATH WAS REMOVED AND IT WAS FOUND TO BE SQUISHED AND NOT SUITABLE FOR USE. THE 14F ISLEEVE INTRODUCER SHEATH WAS DISCARDED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300402 ↗
• MalfunctionSep 24, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DEVICE TIP DAMAGE OCCURRED. PROCEDURE SUMMARY: A 14F ISLEEVE INTRODUCER SHEATH WAS USED DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. AT THE CONCLUSION OF THE PROCEDURE WHEN THE 14F ISLEEVE INTRODUCER SHEATH WAS REMOVED A TEAR AT THE TIP OF THE DEVICE WAS IDENTIFIED WITH A PARTIALLY DETACHED FLAP. PATIENT STATUS NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292857 ↗
• MalfunctionSep 17, 2024Difficult to Remove; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATYPICAL TIP DAMAGE OCCURRED. THE PATIENT'S FEMORAL ANATOMY CONTAINED MODERATE CALCIUM, STENOSIS, AND TORTUOSITY. A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WAS BEING PERFORMED, UTILIZING A 14F ISLEEVE INTRODUCER SHEATH FOR FEMORAL ACCESS. A 14F ISLEEVE INTRODUCER SHEATH WAS PLACED, THEN BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 25MM NON-BOSTON SCIENTIFIC (BSC) BALLOON CATHETER. DURING WITHDRAW OF THE 25MM NON-BSC BALLOON CATHETER, RESISTANCE WAS NOTED BUT THE BALLOON WAS SUCCESSFULLY REMOVED. A SIZE LARGE ACURATE NEO2 VALVE WAS PREPARED AND LOADED ONTO AN ACURATE NEO2 TRANSFEMORAL (TF) DELIVERY SYSTEM (DS). THE ACURATE NEO2 TF DS WAS ADVANCED INTO POSITION AND THE ACURATE NEO2 VALVE WAS IMPLANTED SUCCESSFULLY. UPON REMOVAL OF THE 14F ISLEEVE INTRODUCER SHEATH FROM THE PATIENT'S ANATOMY, THE RADIO-OPAQUE TIP WAS NOTED TO HAVE MORE TEARING THAN TYPICAL WITH A NOTICEABLE FLAP. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20239813 ↗