StarClose SE™ 14679-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 08717648175060), received between Oct 17, 2016 and Nov 3, 2025 — classified as 66 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (17 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 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THIS WAS CLOSURE OF AN UNSPECIFIED ACCESS SITE USING A STARCLOSE DEVICE AFTER AN UNKNOWN PROCEDURE. REPORTEDLY, THE SHEATH DID NOT SPLIT ALL THE WAY DOWN AND ONLY SPLIT HALFWAY DURING STEP THREE WHEN ADVANCING THE THUMB ADVANCER. THE SAFETY RELEASE WAS PRESSED, AND THE DEVICE WAS REMOVED. THE DEVICE CLIP WAS NOT DEPLOYED. THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT PROVIDED. 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 23458741 ↗
• MalfunctionNov 3, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THIS WAS CLOSURE OF AN UNSPECIFIED ACCESS SITE USING A STARCLOSE DEVICE AFTER AN ANGIOGRAPHY INTERVENTIONAL PROCEDURE USING A 6F SHEATH. REPORTEDLY, THE SHEATH DID NOT SPLIT ALL THE WAY DOWN AND ONLY SPLIT HALFWAY DURING STEP THREE WHEN ADVANCING THE THUMB ADVANCER. THE SAFETY RELEASE WAS PRESSED, AND THE DEVICE WAS REMOVED. THE DEVICE CLIP WAS NOT DEPLOYED. THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT PROVIDED. 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 23458493 ↗
• MalfunctionNov 3, 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 LOWER LEFT EXTREMITY ANGIOGRAPHY INTERVENTIONAL PROCEDURE USING A 6F SHEATH. REPORTEDLY, THE SHEATH DID NOT SPLIT ALL THE WAY DOWN AND ONLY SPLIT HALFWAY DURING STEP THREE WHEN ADVANCING THE THUMB ADVANCER. THE SAFETY RELEASE WAS PRESSED, AND THE DEVICE WAS REMOVED. THE DEVICE CLIP WAS NOT DEPLOYED. MANUAL 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 23458424 ↗
• InjuryAug 13, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THIS WAS AN ARTERIOTOMY CLOSURE OF A RIGHT COMMON FEMORAL ARTERY USING A STARCLOSE DEVICE AFTER AN INTERVENTIONAL PROCEDURE WITH A 6F SHEATH. REPORTEDLY, AFTER PERFORMING ALL FOUR STEPS WITHOUT ISSUES, THE CLIP DID NOT DETACH FROM THE DEVICE. MANUAL COMPRESSION 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 22800161 ↗
• InjuryAug 5, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THE SHEATH DID NOT SPLIT AND THE THUMB ADVANCER GOT STUCK. THE DEVICE WAS REMOVED AND REPLACED. AN ADDITIONAL STARCLOSE WAS THEN USED TO ACHIEVE HEMOSTASIS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22716412 ↗
• InjuryJun 27, 2025Entrapment of Device; Difficult to Open or Close; Mechanical Jam; Entrapment of Device; Difficult to Open or Close; Mechanical Jam

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A STARCLOSE DEVICE AFTER A PULMONARY ARTERIOGRAM AND INTERVENTIONAL PROCEDURE USING A 5F SHEATH. REPORTEDLY, THE CLIP WAS DEPLOYED; HOWEVER, THE VESSEL LOCATOR WINGS DID NOT RETRACT AND THE DEVICE COULD NOT BE REMOVED FROM THE PATIENT. THE BAILOUT METHODS WERE USED; HOWEVER, THIS WAS UNSUCCESSFUL AND THE DEVICE STILL COULD NOT BE REMOVED. A VASCULAR SURGEON WAS CALLED WHO PERFORMED CUT DOWN SURGERY TO REMOVE THE DEVICE AND ACHIEVE HEMOSTASIS. IT APPEARED THAT THE CLIP HAD GRABBED THE BOTTOM OF THE ARTERIAL WALL BUT ALSO GRABBED TISSUE. THERE WAS NO ADVERSE PATIENT SEQUELA; HOWEVER, THERE WAS A REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY DUE TO THE NEED FOR THE CUT DOWN SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22349899 ↗
• InjuryMay 13, 2025Off-Label Use; Failure to Cut; Off-Label Use; Failure to Cut

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF A CALCIFIED LEFT COMMON FEMORAL ARTERY USING A STARCLOSE DEVICE AFTER AN INTERVENTIONAL ATHERECTOMY AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE WITH A 5F SHEATH. REPORTEDLY, THE THUMB ADVANCER WAS UNABLE TO ADVANCE AS RESISTANCE WAS FELT. THE SHEATH WAS PARTIALLY SPLIT, AND THE GARAGE TUBE WAS FLARED OUT. THE SHEATH WAS THEN MANUALLY SPLIT TO DEPLOY THE CLIP. BLEEDING WAS OBSERVED AFTER DEPLOYMENT AND MANUAL COMPRESSION WAS USED TO ACHIEVED 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 22010559 ↗
• InjuryMar 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS WAS A VESSEL CLOSURE OF AN UNKNOWN VESSEL USING A STARCLOSE SE RELATIVE TO AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE DEVICE HAD AN UNKNOWN FAILURE. AN UNSPECIFIED METHOD WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21623326 ↗
• InjuryMar 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS WAS A VESSEL CLOSURE OF AN UNKNOWN VESSEL USING A STARCLOSE SE RELATIVE TO AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE DEVICE HAD AN UNKNOWN FAILURE. AN UNSPECIFIED METHOD WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619183 ↗
• InjuryFeb 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A STARCLOSE SE AFTER AN ATTEMPTED PERIPHERAL PROCEDURE WITH A 6F SHEATH. CONTRALATERAL ACCESS WAS NOT SUCCESSFUL. THE PROCEDURE COULD NOT BE PERFORMED. REPORTEDLY, THE STARCLOSE SE CLIP WAS DEPLOYED TO CLOSE THE ACCESS SITE. AFTER DEPLOYMENT, PULSATILE BLEEDING WAS OBSERVED. IT COULD NOT BE DETERMINED IF THE CLIP HAD DEPLOYED PROPERLY AS THE DEVICE WAS DISCARDED IMMEDIATELY AFTER USE. HOWEVER, THERE WAS NO NOTED RESISTANCE OR ISSUE WITH DEPLOYMENT OF THE CLIP. MANUAL COMPRESSION 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 21409663 ↗
• InjuryOct 14, 2024Leak/Splash; Material Separation; No Audible Prompt/Feedback; Leak/Splash; Material Separation; No Audible Prompt/Feedback

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A STARCLOSE DEVICE AFTER A RIGHT CAROTID INTERVENTIONAL PROCEDURE USING A 5F SHEATH. REPORTEDLY, THE PROCEDURE WAS A HIGH STICK. THE LAB TECH INTRODUCED THE DEVICE INTO THE SHEATH; HOWEVER, THE FIRST CLICK DIDN¿T HAPPEN AND WAS NOT HEARD. THE DEVICE WAS ATTEMPTED TO BE REMOVED, BUT THE HUB DETACHED FROM THE SHEATH AND THE SHEATH REMAINED IN THE PATIENT AND WAS BLEEDING. A VASCULAR SURGEON GAINED ACCESS ON THE LCFA USING UP AND OVER TECHNIQUE TO REMOVED THE REST OF THE DEVICE. TWO NON-ABBOTT STENTS WERE THEN PLACED TO STOP THE BLEEDING AND ACHIEVE HEMOSTASIS IN THE RCFA. THE SURGEON THEN PERFORMED A CUT-DOWN ON THE RCFA TO CONFIRM ALL SECTIONS OF THE DEVICE WERE REMOVED FROM THE PATIENT. THE CUT-DOWN WAS TREATED WITH SURGICAL SUTURING. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20439706 ↗
• InjurySep 18, 2024Difficult to Insert; Off-Label Use; Material Split, Cut or Torn; Difficult to Insert; Off-Label Use; Material Split, Cut or Torn

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE CALCIFIED RIGHT COMMON FEMORAL ARTERY USING A STARCLOSE DEVICE AFTER AN ANTEGRADE RIGHT LEG ANGIOGRAM PROCEDURE USING A 6F SHEATH. REPORTEDLY, A LOT OF RESISTANCE WAS FELT WHEN INSERTING THE EXCHANGE SHEATH OVER THE GUIDE WIRE. THE SHEATH WAS RE-ADJUSTED; HOWEVER, RESISTANCE GOT WORSE. THE SHEATH WAS PULLED OUT AND WAS NOTED TO BE TORN/SPLIT ON THE BOTTOM. THE PHYSICIAN BELIEVES IT WAS AN ANGLE ISSUE. A NON-ABBOTT DEVICE 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 20248485 ↗
• InjurySep 12, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A STARCLOSE SE DEVICE AFTER A TIBIAL BALLOON ANGIOPLASTY INTERVENTIONAL PROCEDURE USING A 6F SHEATH. REPORTEDLY, THERE WAS RESISTANCE ADVANCING THE THUMB ADVANCER AND THE SHEATH DID NOT SPLIT CORRECTLY OR COMPLETELY. THEREFORE, THE CLIP WAS NOT DEPLOYED. MANUAL 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 20206300 ↗
• InjuryApr 26, 2024Off-Label Use; Patient Device Interaction Problem; Off-Label Use; Patient Device Interaction Problem

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY USING A STARCLOSE SE DEVICE AFTER A ILIAC INTERVENTION PROCEDURE USING A 6F SHEATH. REPORTEDLY, THE STARCLOSE CLIP DID NOT ACHIEVE HEMOSTASIS AT THE ACCESS SITE POSSIBLY DUE TO THE PHYSICIAN NOT SPREADING THE ACCESS SITE ENOUGH WITH HEMOSTATS. MANUAL 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 19195727 ↗
• InjuryApr 16, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A STARCLOSE SE AFTER A CEREBRAL ANEURYSM EMBOLIZATION PROCEDURE WITH A 6F SHEATH. REPORTEDLY, THE STARCLOSE WAS DEPLOYED YET DID NOT ACHIEVE HEMOSTASIS. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THE PATIENT'S BLOOD PRESSURE DROPPED. THE PATIENT EXPERIENCED PAIN AND SWELLING IN THE GROIN. A RETROPERITONEAL HEMATOMA WAS OBSERVED. THE HEMATOMA RESOLVED WITH MANUAL COMPRESSION. THE PHYSICIAN INDICATED POST-PROCEDURE COMPLICATIONS WERE UNRELATED TO THE STARCLOSE SE DEVICE. THERE WAS 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 19121273 ↗
• InjuryApr 4, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A STARCLOSE SE AFTER A DIAGNOSTIC CEREBRAL ANGIOGRAM PROCEDURE WITH A 5F SHEATH. REPORTEDLY, THE STARCLOSE WAS DEPLOYED AND DID NOT ACHIEVE HEMOSTASIS. THE PATIENT EXPERIENCED PAIN AND SWELLING IN THE GROIN. A PSEUDOANEURYSM WAS OBSERVED. MANUAL COMPRESSION WAS APPLIED AND ACHIEVED HEMOSTASIS. THE PSEUDOANEURYSM RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Pseudoaneurysm; Swelling/ Edema

  MAUDE report 19047221 ↗
• InjuryJan 8, 2024Improper or Incorrect Procedure or Method; Failure to Cut; Improper or Incorrect Procedure or Method; Failure to Cut

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF A RIGHT COMMON FEMORAL ARTERY USING A STARCLOSE SE AFTER A DIAGNOSTIC CEREBRAL ANGIOGRAM PROCEDURE WITH A 6F SHEATH. REPORTEDLY, THERE WAS RESISTANCE ADVANCING THE THUMB ADVANCER DUE TO THE SHEATH NOT SPLITTING PROPERLY. THE SHEATH FAILED TO SPLIT. PROLONGED MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. POST RECOVERY HOSPITALIZATION WAS PROLONGED. NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: REPORTEDLY, THE SAFETY RELEASE BUTTON WAS NOT USED PRIOR TO REMOVING THE DEVICE. THERE WAS A REPORTED CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18465268 ↗
• InjuryDec 31, 2023Improper or Incorrect Procedure or Method; Failure to Cut; Improper or Incorrect Procedure or Method; Failure to Cut

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF A RIGHT COMMON FEMORAL ARTERY USING A STARCLOSE SE AFTER A DIAGNOSTIC CEREBRAL ANGIOGRAM PROCEDURE WITH A 6F SHEATH. REPORTEDLY, THERE WAS RESISTANCE ADVANCING THE THUMB ADVANCER DUE TO THE SHEATH NOT SPLITTING PROPERLY. THE SHEATH FAILED TO SPLIT. PROLONGED MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. POST RECOVERY HOSPITALIZATION WAS PROLONGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18422984 ↗
• InjuryNov 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT CLOSURE OF AN UNSPECIFIED ACCESS SITE WAS ATTEMPTED USING A STARCLOSE DEVICE. REPORTEDLY, AN UNSPECIFIED FAILURE OCCURRED. THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT PROVIDED. 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 18075020 ↗
• InjuryNov 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT CLOSURE OF AN UNSPECIFIED ACCESS SITE WAS ATTEMPTED USING A STARCLOSE DEVICE. REPORTEDLY, AN UNSPECIFIED FAILURE OCCURRED. THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT PROVIDED. 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 18066031 ↗
• InjuryOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY WAS DONE SUCCESSFULLY WITH A STARCLOSE SE DEVICE AFTER AN ILIAC STENT INTERVENTIONAL PROCEDURE USING A 6F SHEATH. REPORTEDLY, THE DEVICE FUNCTIONED AS INTENDED; HOWEVER, THE PATIENT EXPERIENCED RASHES ON AND OFF SINCE THE PROCEDURE. THE PHYSICIAN DETERMINED THAT THE PATIENT HAS A NICKEL ALLERGY AND THE RASHES WERE CAUSED BY THE STARCLOSE CLIP. THERE WAS NO REPORTED TREATMENT, BUT THE PHYSICIAN PLANS ON REMOVING THE CLIP IN THE FUTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17933815 ↗
• InjuryJun 23, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A STARCLOSE SE DEVICE AFTER A RIGHT TIBIAL BALLOON CATHETER INTERVENTIONAL PROCEDURE USING A 6F SHEATH. REPORTEDLY, WHEN THE PLUNGER WAS PUSHED, THE VESSEL LOCATOR WINGS DID NOT OPEN. THERE WAS NO RESISTANCE PUSHING THE PLUNGER. THE DEVICE WAS REMOVED AND MANUAL 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 17192152 ↗
• InjuryMay 31, 2023Noise, Audible; Patient Device Interaction Problem; Noise, Audible; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE DEVICE AFTER A DIAGNOSTIC PROCEDURE WITH A 6F SHEATH. REPORTEDLY, THE CLIP DEPLOYED, BUT AFTER A 2 MINUTE GROIN HOLD, THERE WAS CONTINUED BLEEDING. THE PHYSICIAN NOTED AN AUDIBLE "THUG" SOUND AND NOT THE USUAL DISTINCT/CRISP SOUND EXPECTED WHEN DEPLOYING STARCLOSE. THE CLIP REMAINED IN THE PATIENT. MANUAL ARTERIAL COMPRESSION 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 17032212 ↗
• InjuryMay 30, 2023Failure to Fire; 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 COILING ANEURYSM EMBOLIZATION PROCEDURE USING A 6F SHEATH. REPORTEDLY, THE CLIP DEPLOYED; HOWEVER, HEMOSTASIS WAS NOT FULLY ACHIEVED AS ONLY PARTIAL CAPTURE OF THE VESSEL WAS OBTAINED WITH THE CLIP. MANUAL 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 17025110 ↗
• InjuryNov 22, 2022Firing Problem; Firing Problem

  IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE DEVICE AFTER A DIAGNOSTIC LEFT LEG ANGIOGRAM PROCEDURE WITH A 6F SHEATH. REPORTEDLY, THE DEVICE DIDN'T DEPLOY CORRECTLY AS THE CLIP WAS DEPLOYED INTO THE EXCHANGE SHEATH [FIRING PROBLEM]. MANUAL ARTERIAL COMPRESSION 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 15846810 ↗