StarClose SE™ 14679-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 589 adverse event reports that list this exact device (DI 08717648079467), received between Aug 5, 2016 and Sep 29, 2026 — classified as 535 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (128 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 589 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Difficult to Remove; Failure to Fire; Mechanical Jam

  It was reported that this was an arteriotomy closure of a left common femoral artery using a StarClose SE device after a diagnostic angiogram procedure with a 5F sheath. Reportedly, the clip did not deploy and the emergency release did not work; however, the device was ultimately able to be removed. Manual compression was applied to achieve hemostasis. There were no reported adverse patient effects. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936933 ↗
• MalfunctionSep 28, 2026Noise, Audible; Firing Problem

  It was reported that this was an arteriotomy closure using a StarClose device after a procedure. Reportedly, after deploying the clip, the flex guide or delivery tube snapped "[audible noise]", forcing the physician to pull the clip out of artery "[clip stuck on distal end of sheath or device when device was withdrawn]". Manual compression was used to achieve hemostasis. There were no reported adverse patient effects. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917956 ↗
• MalfunctionAug 31, 2026Misfire

  It was reported this was an unknown procedure to treat an unspecified vessel. Reportedly, the StarClose clip deployed prematurely. Manual compression was used to achieve hemostasis. There were no adverse patient effects. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525322 ↗
• MalfunctionMay 12, 2026Mechanical Jam

  IT WAS REPORTED THAT THIS WAS A CLOSURE USING A STARCLOSE SE DEVICE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, IN STEP 2, THE PLUNGER WOULD NOT GO DOWN. THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT PROVIDED. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25152773 ↗
• MalfunctionApr 30, 2026Misfire

  THIS WAS REPORTED AS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A STARCLOSE DEVICE WITH A 6F SHEATH AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE CLIP FIRED BEFORE TRIGGER WAS PRESSED. THE CLIP REMAINED AT THE DISTAL END OF THE SHEATH. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25047124 ↗
• MalfunctionMar 25, 2026Malposition of Device; Firing Problem

  IT WAS REPORTED THAT THIS WAS A CLOSURE USING A STARCLOSE SE DEVICE AFTER A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. REPORTEDLY, THE STARCLOSE DID NOT ATTACH TO VESSEL. DIRECT PRESSURE WAS HELD TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24694429 ↗
• MalfunctionMar 9, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A STARCLOSE SE DEVICE AFTER A LEFT HEART CATHETERIZATION PROCEDURE. REPORTEDLY, THE STARCLOSE SE DEVICE WAS USED 10 DAYS AFTER EXPIRATION. THE STARCLOSE SE DEVICE WAS SUCCESSFULLY USED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24547340 ↗
• MalfunctionFeb 12, 2026Break; Failure to Fire

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A STARCLOSE SE DEVICE AFTER A HEMORRHOIDAL ARTERY EMBOLIZATION PROCEDURE. REPORTEDLY, THE TRIGGER BUTTON WAS PRESSED; HOWEVER, THE CLIP DID NOT DEPLOY. THE CLIP WAS NOT IN THE PATIENT ANATOMY OR THE DEVICE. THE CLIP WAS LATER SEEN LOOSE INSIDE THE PACKAGE WITH THE STARCLOSE SE DEVICE WHEN PACKAGING THE DEVICE AFTER THE PROCEDURE. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED. ANALYSIS OF THE RETURNED STARCLOSE SE DEVICE REVEALED DAMAGE NOTED TO THE ONE VESSEL LOCATOR WING AT THE DISTAL END WAS SEPARATED BUT STILL INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24329058 ↗
• MalfunctionDec 17, 2025Product Quality Problem; Failure to Cut; Product Quality Problem; Failure to Cut

  IT WAS REPORTED THAT THIS WAS A CLOSURE OF AN UNSPECIFIED VESSEL USING A STARCLOSE DEVICE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, WHEN COMPLETING STEP 2, (PUSHING THE PLUNGER TO OPEN THE VESSEL LOCATOR WINGS AND INITIATE THE SHEATH SPLIT), THE ENTIRE SHEATH SPLIT AND SEEMED LIKE IT WAS WARPED. THEREFORE, THE CLIP WAS NOT DEPLOYED. THE METHOD OF ACHIEVING HEMOSTASIS WAS NOT REPORTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829934 ↗
• MalfunctionDec 17, 2025Product Quality Problem; Failure to Cut; Product Quality Problem; Failure to Cut

  IT WAS REPORTED THAT THIS WAS A CLOSURE OF AN UNSPECIFIED VESSEL USING A STARCLOSE DEVICE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, WHEN COMPLETING STEP 2, (PUSHING THE PLUNGER TO OPEN THE VESSEL LOCATOR WINGS AND INITIATE THE SHEATH SPLIT), THE ENTIRE SHEATH SPLIT AND SEEMED LIKE IT WAS WARPED. THEREFORE, THE CLIP WAS NOT DEPLOYED. THE METHOD OF ACHIEVING HEMOSTASIS WAS NOT REPORTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829726 ↗
• MalfunctionDec 12, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF A MILDLY CALCIFIED LEFT COMMON FEMORAL ARTERY USING A STARCLOSE DEVICE AFTER AN INTERVENTIONAL PERIPHERAL PROCEDURE WITH A 6F SHEATH. REPORTEDLY WHEN ATTEMPTING TO DEPLOY THE STARCLOSE DEVICE, THE SHEATH WAS UNABLE TO SPLIT WHEN PERFORMING STEP 2. A NEW STARCLOSE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791311 ↗
• MalfunctionDec 11, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY USING A STARCLOSE SE DEVICE AFTER A NEURO INTERVENTION PROCEDURE, USING A 6F SHEATH. REPORTEDLY, THE SHEATH SPLIT CROOKED DURING STEP 2 (SHEATH SPLIT INITIATION). THEREFORE, THE CLIP WAS NOT DEPLOYED. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783552 ↗
• MalfunctionDec 9, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF A CALCIFIED RIGHT COMMON FEMORAL ARTERY USING A STARCLOSE DEVICE AFTER A DIAGNOSTIC PROCEDURE WITH A 6F SHEATH. REPORTEDLY, THE STARCLOSE SE DID NOT DEPLOY CORRECTLY. COMPUTED TOMOGRAPHY WAS PERFORMED AND IT WAS FOUND THAT THE CLIP HAD DEPLOYED INSIDE THE POSTERIOR WALL. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23761079 ↗
• MalfunctionNov 24, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THIS WAS AN ARTERIOTOMY CLOSURE OF A RIGHT COMMON FEMORAL ARTERY USING A PROSTYLE DEVICE AFTER AN INTERVENTIONAL PROCEDURE WITH A 6F SHEATH. REPORTEDLY, DUE TO SCAR TISSUE, THE STARCLOSE DID NOT TAKE TO THE VESSEL WALL. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638615 ↗
• MalfunctionNov 20, 2025Off-Label Use; Mechanical Jam; Off-Label Use; Mechanical Jam

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY USING A STARCLOSE SE DEVICE AFTER A LEFT SUPERFICIAL FEMORAL ARTERY INTERVENTIONAL PROCEDURE USING A 6F SHEATH. SCAR TISSUE WAS PRESENT AT THE ACCESS SITE. REPORTEDLY, RESISTANCE WAS MET DURING THUMB ADVANCEMENT IN STEP 3 AND AT THE SAME TIME THE WHOLE STARCLOSE DEVICE POPPED OUT OF THE VESSEL; HOWEVER, THE VESSEL LOCATOR WINGS REMAINED OPENED WITH THE PLUNGER WAS STILL ENGAGED. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607651 ↗
• MalfunctionNov 17, 2025Unintended System Motion; Mechanical Jam; Unintended System Motion; Mechanical Jam

  PATIENT ID: (B)(6). IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE MILDLY CALCIFIED, RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A STARCLOSE SE DEVICE AFTER A PERCUTANEOUS TRANSLUMINAL PERIPHERAL ANGIOPLASTY PROCEDURE USING A 6F SHEATH. DURING STEP 3 WHEN THE PHYSICIAN WAS DELIVERING THE STARCLOSE SE DEVICE DOWN THE TUBE TO THE COMMON FEMORAL ARTERY, HE ENCOUNTERED SOME PRESSURE AND THE DEVICE JUMPED A BIT. THERE WAS NO ADVERSE EVENT. MANUAL PRESSURE WAS HELD TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE CONDITION RESOLVED AND THE PATIENT WAS DISCHARGED HOME THE SAME DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570502 ↗
• MalfunctionNov 10, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE CALCIFIED COMMON FEMORAL ARTERY USING A STARCLOSE DEVICE AFTER AN INTERVENTIONAL LOWER EXTREMITY ANGIOGRAM PROCEDURE WITH AN 6F SHEATH. REPORTEDLY, THE STARCLOSE DEVICE DID NOT DEPLOY CORRECTLY AS IT REMAINED ON THE DISTAL END OF THE DEVICE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510830 ↗
• MalfunctionOct 30, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THIS WAS A CLOSURE OF AN UNKNOWN VESSEL USING A STARCLOSE DEVICE RELATED TO AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN DEPRESSING THE BLUE PLUNGER, THE PLUNGER DID NOT FULLY DEPRESS AS THE NUMBER TWO WAS NOT VISIBLE IN THE WINDOW. AN UNKNOWN METHOD WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23429695 ↗
• MalfunctionOct 28, 2025Off-Label Use; Difficult to Open or Close; Off-Label Use; Difficult to Open or Close

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE CALCIFIED RIGHT COMMON FEMORAL ARTERY WITH A STARCLOSE DEVICE USING A 6F SHEATH AFTER A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. REPORTEDLY, AFTER DEPLOYING THE CLIP, THE VESSEL LOCATOR WINGS STAYED OPEN. THE SAFETY RELEASE MECHANISM WAS USED FOR SUCCESSFUL RELEASE OF THE DEVICE. THE DEPLOYED CLIP DID NOT ACHIEVE HEMOSTASIS; THEREFORE, MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23405135 ↗
• MalfunctionOct 28, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A STARCLOSE DEVICE AFTER A RENAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) INTERVENTIONAL PROCEDURE USING A 6F SHEATH. REPORTEDLY, THE STARCLOSE DEVICE CAME OUT OF THE VESSEL AFTER ADVANCING THE THUMB ADVANCER. IT HAD CAME OUT WITH VESSEL LOCATOR WINGS OPEN. NO VESSEL OR TISSUE DAMAGE WAS NOTED. THE SHEATH HAD NOT SPLIT COMPLETELY AND THEREFORE THE CLIP WAS NOT DEPLOYED (REMAINED IN DEVICE). MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23403798 ↗
• InjuryOct 7, 2025Entrapment of Device; Mechanical Jam; Firing Problem; Entrapment of Device; Mechanical Jam; Firing Problem

  IT WAS REPORTED THAT THIS WAS ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE DEVICE AFTER A CEREBRAL ANGIOGRAM DIAGNOSTIC PROCEDURE USING A 6F SHEATH. STEP ONE THROUGH THREE WERE PERFORMED AS INTENDED. REPORTEDLY, THE CLIP DID NOT DEPLOY AT STEP FOUR, AND THE SAFETY RELEASE DID NOT WORK, AND THE DEVICE WAS STUCK IN THE ANATOMY. A CUT-DOWN WAS THEN PERFORMED TO REMOVE THE DEVICE AND CLIP. HEMOSTASIS WAS ACHIEVED VIA CUT-DOWN AND SURGICAL SUTURING. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23240389 ↗
• InjuryOct 3, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED DURING USE OF THE STARCLOSE DEVICE, THE SHEATH FAILED TO PROPERLY DEPLOY, DUE TO THE ACCESS SHEATH NOT TEARING PROPERLY. AN UNKNOWN METHOD WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23214196 ↗
• InjurySep 11, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF A RIGHT COMMON FEMORAL ARTERY USING A STARCLOSE DEVICE AFTER AN INTERVENTIONAL GASTROINTESTINAL BLEED PROCEDURE WITH A 6FR SHEATH. REPORTEDLY, THE VALVE GOT STUCK CAUSING THE INTRODUCER TO BLEED BACK. A NEW STARCLOSE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025533 ↗
• InjurySep 11, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A STARCLOSE DEVICE AFTER AN INTERVENTIONAL PERIPHERAL PROCEDURE USING A 6F SHEATH. REPORTEDLY, RESISTANCE WAS NOTED WHILE DEPRESSING THE PLUNGER DURING STEP 2. THE #2 WAS VISIBLE HOWEVER, THE DEVICE DID NOT WORK. THE PHYSICIAN ATTEMPTED TO USE THE SAFETY RELEASE BUTTON, BUT DID NOT WORK SINCE THE LOCATOR WINGS HAD NOT BEEN DEPLOYED. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025049 ↗
• InjuryAug 18, 2025Failure to Cut; Deformation Due to Compressive Stress; Failure to Cut; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY USING A SMALL-BORE SHEATH WITH A STARCLOSE DEVICE AFTER A BILATERAL ILIAC STENTING PROCEDURE. REPORTEDLY, THE THUMB ADVANCER COULD NOT BE FULLY ADVANCED. THE SHEATH BECAME SHREDDED, AND IT WAS NOTED THAT THE GARAGE LEAVES WERE BENT. MANUAL COMPRESSION WAS HELD FOR 30 MINUTES TO ACHIEVE HEMOSTASIS. ALTHOUGH A DELAY WAS REPORTED DUE TO THE NEED FOR MANUAL COMPRESSION, THERE WAS NO SIGNIFICANT IMPACT TO THE PATIENT DUE TO THE DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22828563 ↗