Prostar™ 12322-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 08717648000621), received between Jan 30, 2018 and May 19, 2025 — classified as 74 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (37 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 85 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS WAS A CLOSURE OF AN UNKNOWN VESSEL USING FIVE PROSTAR DEVICES. REPORTEDLY, AN UNKNOWN ISSUE OCCURRED. AN UNKNOWN METHOD 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 22048564 ↗
• InjuryMay 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS WAS A CLOSURE OF AN UNKNOWN VESSEL USING FIVE PROSTAR DEVICES. REPORTEDLY, AN UNKNOWN ISSUE OCCURRED. AN UNKNOWN METHOD 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 22048563 ↗
• InjuryMay 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS WAS A CLOSURE OF AN UNKNOWN VESSEL USING FIVE PROSTAR DEVICES. REPORTEDLY, AN UNKNOWN ISSUE OCCURRED. AN UNKNOWN METHOD 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 22048560 ↗
• InjuryMay 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS WAS A CLOSURE OF AN UNKNOWN VESSEL USING FIVE PROSTAR DEVICES. REPORTEDLY, AN UNKNOWN ISSUE OCCURRED. AN UNKNOWN METHOD 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 22048559 ↗
• InjuryMay 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS WAS A CLOSURE OF AN UNKNOWN VESSEL USING FIVE PROSTAR DEVICES. REPORTEDLY, AN UNKNOWN ISSUE OCCURRED. AN UNKNOWN METHOD 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 22048558 ↗
• InjuryAug 9, 2024Entrapment of Device; Retraction Problem; Failure to Fire; Entrapment of Device; Retraction Problem; Failure to Fire

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY USING A PROSTAR XL AFTER AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE WITH A 10F SHEATH. REPORTEDLY, THE PROSTAR XL HANDLE WAS REMOVED WITH ONLY THREE NEEDLES COMING OUT OF THE HUB. IT WAS NOT POSSIBLE TO REMOVE ONE NEEDLE. AFTER MANY ATTEMPTS TO REMOVE THE NEEDLE, IT WAS STILL STUCK IN THE GUIDE. THE SUTURE WAS CUT AND THE DEVICE REMOVED WITH SIGNIFICANT VESSEL DAMAGE. A PROGLIDE SUTURE WAS DEPLOYED IN AN ATTEMPT TO ACHIEVE HEMOSTASIS YET THE SUTURE DID NOT CATCH THE VESSEL. A SURGICAL CUT DOWN WAS PERFORMED WITH SURGICAL CLOSURE. NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19949142 ↗
• InjuryApr 24, 2024Failure to Fire; Failure to Fire

  THE DATE OF PROCEDURE WILL BE ESTIMATED AS (B)(6) 2024. IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF AN UNSPECIFIED ACCESS SITE WAS ATTEMPTED WITH A PROSTAR DEVICE AFTER A THORACIC ENDOVASCULAR AORTIC REPAIR INTERVENTIONAL PROCEDURE. REPORTEDLY, NEEDLE POSITION MISSED THE INTENDED OPENING ON THE DEVICE WITH TWO PROSTAR DEVICES. A CUT-DOWN WITH SURGICAL SUTURING WERE PERFORMED TO ACHIEVE HEMOSTASIS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19174867 ↗
• InjuryApr 24, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF AN UNSPECIFIED ACCESS SITE WAS ATTEMPTED WITH A PROSTAR DEVICE AFTER A THORACIC ENDOVASCULAR AORTIC REPAIR INTERVENTIONAL PROCEDURE. REPORTEDLY, NEEDLE AT THE 10-O-CLOCK POSITION MISSED THE INTENDED OPENING ON THE DEVICE WITH TWO PROSTAR DEVICES. A CUT-DOWN WITH SURGICAL SUTURING WERE PERFORMED TO ACHIEVE HEMOSTASIS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19174828 ↗
• InjuryApr 8, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THIS WAS A VESSEL PUNCTURE CLOSURE USING TWO PROSTAR DEVICES AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE NEEDLE IN THE 10 O'CLOCK POSITION, MISFIRED WITH BOTH DEVICES. NEEDLE BACK DOWN WAS SUCCESSFULLY PERFORMED. A NEW PROSTAR 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 19067268 ↗
• InjuryApr 8, 2024Entrapment of Device; Failure to Fire; Entrapment of Device; Failure to Fire

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A PROSTAR RELATIVE TO AN INTERVENTIONAL PROCEDURE. REPORTEDLY, REPORTEDLY, THE NEEDLE IN THE 10 O'CLOCK POSITION, MISFIRED. NEEDLE BACK DOWN WAS UNSUCCESSFUL AND THE DEVICE WAS STUCK IN THE PATIENT. A CUT DOWN WAS PERFORMED TO REMOVE THE STUCK DEVICE AND ACHIEVE HEMOSTASIS. DUE TO THE CUT DOWN, A CLINICALLY SIGNIFICANT DELAY WAS REPORTED. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067236 ↗
• InjuryApr 8, 2024Failure to Fire; Failure to Fire

  PROCEDURE DATE IS ESTIMATED. IT WAS REPORTED THAT THIS WAS A VESSEL PUNCTURE CLOSURE USING TWO PROSTAR DEVICES AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE NEEDLE IN THE 10 O'CLOCK POSITION, MISFIRED WITH BOTH DEVICES. NEEDLE BACK DOWN WAS SUCCESSFULLY PERFORMED. A NEW PROSTAR 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 19067133 ↗
• InjuryMar 21, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED WITH THREE PROSTAR DEVICES RELATED TO AN INTERVENTIONAL PROCEDURE WITH A 10F SHEATH. REPORTEDLY, THE NEEDLE DID NOT LINE UP WITH THE OPENING FOR ALL THREE DEVICES. AN ADDITIONAL PROSTAR 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 18955516 ↗
• InjuryMar 21, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED WITH THREE PROSTAR DEVICES RELATED TO AN INTERVENTIONAL PROCEDURE WITH A 10F SHEATH. REPORTEDLY, THE NEEDLE DID NOT LINE UP WITH THE OPENING FOR ALL THREE DEVICES. AN ADDITIONAL PROSTAR 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 18955514 ↗
• InjuryMar 21, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED WITH THREE PROSTAR DEVICES RELATED TO AN INTERVENTIONAL PROCEDURE WITH A 10F SHEATH. REPORTEDLY, THE NEEDLE DID NOT LINE UP WITH THE OPENING FOR ALL THREE DEVICES. AN ADDITIONAL PROSTAR 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 18955513 ↗
• InjuryMar 21, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THIS WAS A VESSEL CLOSURE OF AN UNSPECIFIED ACCESS SITE USING TWO PROSTAR DEVICES. REPORTEDLY, THE NEEDLE DID NOT LINE UP WITH THE OPENING FOR BOTH DEVICES. AN ADDITIONAL PROSTAR 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 18955055 ↗
• InjuryMar 21, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY USING A PROSTAR DEVICE RELATED TO AN INTERVENTIONAL PROCEDURE WITH A 6F SHEATH. REPORTEDLY, THE NEEDLE DID NOT LINE UP WITH THE OPENING. AN ADDITIONAL PROSTAR 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 18954983 ↗
• InjuryMar 21, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THIS WAS A VESSEL CLOSURE OF AN UNSPECIFIED ACCESS SITE USING TWO PROSTAR DEVICES. REPORTEDLY, THE NEEDLE DID NOT LINE UP WITH THE OPENING FOR BOTH DEVICES. AN ADDITIONAL PROSTAR 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 18954981 ↗
• InjuryMar 21, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THIS WAS A VESSEL CLOSURE OF AN UNSPECIFIED ACCESS SITE USING A PROSTAR DEVICE RELATED TO AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE NEEDLE DID NOT LINE UP WITH THE OPENING. AN ADDITIONAL PROSTAR 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 18954665 ↗
• InjuryFeb 2, 2023Off-Label Use; Obstruction of Flow; Off-Label Use; Obstruction of Flow

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE MILD RIGHT COMMON FEMORAL ARTERY USING A PROSTAR XL AFTER A FENESTRATED ENDOVASCULAR ANEURYSM REPAIR (FEVAR) PROCEDURE USING A 16F SHEATH. REPORTEDLY, THE PROSTAR XL WAS SUCCESSFULLY PREFLUSHED. AFTER INSERTION INTO THE VESSEL, THERE WAS NO BLEEDBACK FROM THE MARKER LUMEN. THE DEVICE WAS SUCCESSFULLY FLUSHED AGAIN AND REINSERTED WITH NO BLEEDBACK SEEN. TWO PROSTYLE DEVICES WERE 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 16285788 ↗
• InjuryJan 30, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH TWO PROSTAR DEVICES USING THE PRE-CLOSE TECHNIQUE VIA AN 8F SHEATH HOLE PRIOR TO AN INTERVENTIONAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. REPORTEDLY, THERE WAS NO BLEED-BACK WITH EITHER OF THE DEVICES WHEN THEY WERE INSERTED IN THE PATIENT. THE USE OF ANY ADDITIONAL PROSTAR DEVICES WAS ABANDONED AND THE SUTURES OF TWO PROSTYLE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO A 16F SHEATH AND THE EVAR PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROSTYLE SUTURES. 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 16268620 ↗
• InjuryJan 30, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH TWO PROSTAR DEVICES USING THE PRE-CLOSE TECHNIQUE VIA AN 8F SHEATH HOLE PRIOR TO AN INTERVENTIONAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. REPORTEDLY, THERE WAS NO BLEED-BACK WITH EITHER OF THE DEVICES WHEN THEY WERE INSERTED IN THE PATIENT. THE USE OF ANY ADDITIONAL PROSTAR DEVICES WAS ABANDONED AND THE SUTURES OF TWO PROSTYLE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO A 16F SHEATH AND THE EVAR PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROSTYLE SUTURES. 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 16268593 ↗
• MalfunctionNov 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS WAS A VESSEL CLOSURE OF AN UNKNOWN VESSEL USING A PROSTAR XL AFTER AN UNKNOWN PROCEDURE. REPORTEDLY, THE DEVICE BROKE OR MALFUNCTIONED. 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 15711569 ↗
• InjuryNov 1, 2022Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS WAS A VESSEL CLOSURE OF AN UNKNOWN VESSEL USING A PROSTAR XL AFTER AN UNKNOWN PROCEDURE. REPORTEDLY, THE DEVICE BROKE OR MALFUNCTIONED. 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. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A SEPARATED SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15711398 ↗
• InjuryMay 4, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A PROSTAR DEVICE AFTER AN ABDOMINAL AORTIC ANEURYSM INTERVENTIONAL PROCEDURE USING A 12F SHEATH. REPORTEDLY, THE KNOTS WERE SUCCESSFULLY ADVANCED AND TIGHTENED (WORKED AS INTENDED); HOWEVER, COMPLETE HEMOSTASIS WAS NOT ACHIEVED AS BLEEDING CONTINUED. A CUTDOWN AND MANUAL SUTURING WERE DONE 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 14280393 ↗
• InjuryJan 4, 2022Product Quality Problem; Failure to Fire; Product Quality Problem; Failure to Fire

  IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING TWO PROSTAR XL DEVICES WITH A 10F SHEATH AFTER AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. REPORTEDLY, THE NEEDLES DID NOT COME OUT THROUGH THE HUB FOR BOTH DEVICES AND DEPLOYMENT FELT DIFFERENT. A THIRD PROSTAR XL DEVICE WAS USED AND FELT NORMAL. THE THIRD DEVICE 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 13156249 ↗