ANGIO-SEAL C610134Recalls & reported problems

Summary

The FDA's MAUDE database contains 179 adverse event reports that list this exact device (DI 00389701011783), received between Jul 31, 2017 and Mar 8, 2022 — classified as 1 death, 99 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (34 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 25 most recent of 179 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 2022Activation Problem; Activation Problem

  THE USER FACILITY REPORTED THAT DURING DEPLOYMENT THE INVOLVED ANGIO-SEAL DEVICE TAMP TUBE DID NOT COME DOWN. BACK PRESSURE WAS CONTINUED. BLEEDING WAS NOTICED WHEN THE SUTURE WAS CUT. MANUAL PRESSURE WAS HELD. THE PATIENT'S PEDAL PULSES WERE INTACT. THE PROCEDURE PERFORMED WAS A CORONARY PERCUTANEOUS CORONARY INTERVENTION (PCI). THE PATIENT WAS IN STABLE CONDITION PRE AND POST SURGERY. THERE WAS NO HEMATOMA, HOWEVER, EXTENDED MANUAL PRESSURE WAS HELD. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. THERE WAS NO DIRECT ALLEGATION THAT THE INVOLVED ANGIO-SEAL DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S NEED FOR MEDICAL INTERVENTION. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13686587 ↗
• InjuryDec 5, 2021Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT THE WHILE DEPLOYING THE ANGIO-SEAL DEVICE, THE WHOLE SYSTEM PULLED OUT AND PRESSURE NEEDED TO BE HELD. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED 15NOVEMBER2021: PROCEDURE BEING PERFORMED WAS A NEURO INTERVENTION WITH A 6FR SHEATH. THERE WERE NO DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. AFTER SETTING THE ANCHOR, THE ANCHOR/SUTURE/COLLAGEN PULLED OUT WHEN PULLING BACK THE DEVICE. THERE WAS NO BLOOD LOSS. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12931493 ↗
• MalfunctionOct 12, 2021Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT DURING A PERIPHERAL ARTERIOGRAM WITH INTERVENTION, THE DOCTOR CHECKED THE 6FR ACCESS SITE TO SEE IF THE SITE WAS ACCEPTABLE FOR AN ANGIO-SEAL CLOSURE. AFTER CONFIRMING THE STICK SITE AS ACCEPTABLE FOR CLOSURE, HE PROCEEDED IN USING THE 6FR ANGIO-SEAL. HE LOCATED THE VESSEL, SET THE FOOTPLATE, AND SEALED THE VESSEL WITHOUT DIFFICULTLY AND THE SITE WAS FREE FROM ANY BLEEDING POST CLOSURE. NEXT, HE ATTEMPTED TO RELEASE THE SUTURE (EVOLUTION), HOWEVER AFTER MULTIPLE ATTEMPTS TO DEPRESS THE WHITE BUTTON USED TO RELEASE THE SUTURE, THE SUTURE WOULD NOT RELEASE AT ALL. SO, THEY DECIDED TO CUT THE TUBE, TO REMOVE THE DEVICE AND CUT THE SUTURE BELOW SKIN LEVEL. THE DEPLOYMENT WENT GREAT HOWEVER, HE HAD TO CUT THE DEVICE TO REMOVE IT FROM STICK TRACT. THE PATIENT WAS NOT HARMED, AND NO BLOOD LOSS WAS NOTED. A 6FR PINNACLE EXCHANGED FOR 6FR DESTINATION WAS SHEATHS USED FOR PROCEDURE. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS UNSATISFACTORY BUT ACCEPTABLE. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12616130 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE PATIENT GOT UP FOR THE FIRST TIME TO USE THE BATHROOM AROUND NOON AND ON THE WAY BACK TO BE COMPLAINED OF PAIN IN HER RIGHT LEG. SHE HAD AN 8CM HEMATOMA. PRESSURE WAS HELD AND A FEMSTOP WAS APPLIED AT THE SITE. THE FEMORAL ARTERY WAS VISUALIZED PRIOR TO CLOSURE. THERE WAS NO ACCESS COMPLICATION WERE NOTED. THE PROCEDURE PERFORMED WAS A MITRAL CLIP. PATIENT IS KNOWN TO BE STABLE. ADDITIONAL INFORMATION 15SEPTEMBER 2021: THE PROCEDURE SHEATH WAS A 7FR. THERE WERE NOTES REGARDING DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THERE WERE NO NOTES REGARDING ANY ISSUES WITH INSERTION, DEPLOYMENT, OR WITHDRAWAL OF THE DEVICE.

  Patient problems: Hematoma; Pain

  MAUDE report 12615510 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL DEVICE APPEARED TO DEPLOY FINE, HOWEVER AFTER CUTTING THE STRING AT THE END, THE ANGIO-SEAL MATERIAL PROTRUDED OUT OF THE SKIN AND A HEMATOMA FORMED. IT APPEARED THAT IT DID NOT TAMP DOWN OVER THE ARTERIOTOMY SITE. THERE WERE NO ISSUES WITH ACCESS. THEY STARTED WITH A 5-FRENCH SHORT PROCEDURAL SHEATH AND EXCHANGED FOR A 6-FRENCH SHUTTLE. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THERE WERE NO ISSUES WITH USING THE DEVICE. ULTIMATELY, PRESSURE WAS HELD FOR APPROXIMATELY 30 MINUTES TO ACHIEVE HEMOSTASIS. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE. IT LOOKED OK AND SEEMED TO DEPLOY OK UNTIL THE VERY END. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 16SEPT2021. THE PROCEDURE WAS A PIPELINE PLACEMENT/NEURO ANEURYSM EMBOLIZATION.

  Patient problems: Hematoma

  MAUDE report 12591443 ↗
• MalfunctionSep 8, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL EVOLUTION WAS USED DURING THE PROCEDURE. THE RIGHT GROIN WAS SUCCESSFULLY ENGAGED WITH A 6FR ANGIO-SEAL SHEATH AND GUIDEWIRE AND 6FR EVOLUTION. THE PROPER STEPS WERE FOLLOWED, AND AN ANGIO WAS TAKEN AND NO ACUTE ANGLES WERE PRESENT WHICH POTENTIALLY COULD AFFECT DEPLOYMENT. AFTER SEEING GREEN INDICATOR, THE RT WENT TO PUSH RELEASE BUTTON, AND NOTHING HAPPENED. THE RT TRIED MULTIPLE TIMES TO PUSH WITH BOTH THUMBS AT ONE POINT, THE SUTURE WOULD STILL NOT RELEASE. THE RT MANUALLY CUT THE SHEATH, ETC. IN THE VISIBLE WINDOW, REMOVED PIECES MANUALLY, CUT THE SUTURE AT SKIN LEVEL PER PROTOCOL. THE RT VALIDATED PULSES AT SITE AND DISTALLY. NO HEMATOMAS. THE ANGIO-SEAL WAS DEPLOYED MANUALLY SUCCESSFULLY. THE PATIENT'S CONDITION WAS STABLE, NO ISSUES. THE PROCEDURE OUTCOME WAS SUCCESSFUL, DIAGNOSTIC LHC. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 19AUG2021. OTHER DEVICES USED WAS NOT AN ISSUE FOR THEM; USED GLIDEWIRE, J-WIRE, PINNACLE SHEATH, WITHOUT ANY ISSUE. THERE WERE NO ISSUES WITH ARTERIAL ACCESS. NO KNOWN PLAQUE OR STENOSIS, ETC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12438013 ↗
• InjuryAug 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED AN ISSUE WITH THE ANGIO-SEAL EVOLUTION DEVICE SIX HOURS AFTER THE PROCEDURE. THE PATIENT WAS AT HOME AND THERE WAS A SMALL AMOUNT OF BLEEDING AT THE ACCESS SITE. THE PATIENT RETURNED TO THE HOSPITAL AND NO INJURY WAS NOTED, HOWEVER THERE WAS A SMALL HEMATOMA THAT HAD FORMED. THE PROCEDURE PERFORMED WAS A DIAGNOSTIC LEG ANGIO. MANUAL COMPRESSION WAS PERFORMED.

  Patient problems: Hematoma

  MAUDE report 12292267 ↗
• InjuryAug 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THE ANGIO-SEAL EVOLUTION WAS USED AND TWO HOURS POST-OPERATIVE THERE WAS A HEMATOMA FORMATION. THE TYPE OF PROCEDURE BEING PERFORMED WAS A GI BLEED EMBOLIZATION. THERE WAS NO BLOOD LOSS. MANUAL COMPRESSION WAS PERFORMED.

  Patient problems: Hematoma

  MAUDE report 12281447 ↗
• InjuryJun 2, 2021Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THE ANGIO-SEAL EVOLUTION DEVICE CAME OUT OF THE BODY DURING PULLBACK. THE PROCEDURE PERFORMED WAS A NEURO INTERVENTION USING A 6 FR SHEATH. THE CONDITION OF THE PATIENT WAS GOOD. MANUAL PRESSURE WAS HELD, AND THE CLOSURE DEVICE WAS NOT PLACED. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 13MAY2021: THERE WERE NO DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. A PRE DEPLOYMENT ANGIOGRAM WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11921934 ↗
• InjuryApr 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT WHILE THEY WERE USING THE ANGIO-SEAL DEVICE THERE WAS AN INITIAL CLICK WHEN PIECING TOGETHER HOWEVER THEN NO TENSION OR SERIES OF CLICKS WHEN PULLING BACK. THE DOCTOR STATED THAT BOTH THE ANCHOR AND THE COLLAGEN ARE INSIDE OF THE PATIENT HOWEVER, THE ANCHOR IS NOT IN THE CORRECT SPOT THEREFORE HEMOSTASIS WAS NOT ACHIEVED, AND MANUAL PRESSURE WAS APPLIED. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 05APR2021. THE ANCHOR AND COLLAGEN WERE IN THE PATIENT. THE STRING WAS CONNECTED TO THE ANCHOR, HOWEVER, NOT CONNECTED TO THE HANDLE. AN ULTRASOUND WAS PERFORMED TO MAKE SURE THAT THE ANCHOR WAS NOT OCCLUSIVE IN THE COMMON FEMORAL ARTERY, AND IT WAS NOT. DOPPLER SIGNALS WERE UNCHANGED AT THE FOOT FROM PRE-OP, SO UNLIKELY TO HAVE EMBOLIZED. THE PROCEDURE PRIOR TO USING THE ANGIO-SEAL CLOSURE DEVICE WAS A SUPERFICIAL FEMORAL ARTERY (SFA) ANGIOPLASTY ON CONTRALATERAL LEG. A 6FR PROCEDURAL SHEATH WAS USED. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11698535 ↗
• InjuryMar 31, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B(4). THE EVENT DESCRIPTION STATES TERUMO MEDICAL ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE FAILED TO DEPLOY. THE PHYSICIAN CHOSE TO HOLD PRESSURE INSTEAD OF OBTAINING A SECOND DEVICE. PRESSURE WAS HELD AND BLEEDING WAS STOPPED. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 15MARCH2021: MAUDE REPORT NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11597341 ↗
• MalfunctionMar 17, 2021Material Twisted/Bent; Material Twisted/Bent

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL INTRODUCER BENT WHEN ATTEMPTING TO PUT OVER THE WIRE, CAUSING THEM TO DISCARD AND GRAB A NEW ANGIO-SEAL. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS A SUCCESS. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 05MARCH2021: THE TYPE OF PROCEDURE THAT WAS BEING PERFORMED WAS A PERIPHERAL ANGIOGRAM USING A FRENCH SHEATH. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11506228 ↗
• InjuryFeb 11, 2021Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT THE INVOLVED ANGIO-SEAL EVOLUTION WAS USED IN A PERIPHERAL ARTERIOGRAM WITH INTERVENTION ACCESS PROCEDURE. THE RIGHT GROIN EQUIPMENT WAS A 6FR PINNACLE EXCHANGED FOR 6FR 45CM STRAIGHT DESTINATION. AT THE END OF THE PROCEDURE, A PICTURE WAS OBTAINED OF THE ACCESS SITE AND DETERMINED ACCEPTABLE FOR ANGIO-SEAL. THE MD LOCATED THE VESSEL APPROPRIATELY, ADVANCED THE ANGIO-SEAL AND SET IT, THEN RETRACTED THE DEVICE UNTIL HE SAW A GREEN INDICATOR ON THE TAMPER TUBE, NEXT HE PUSHED THE WHITE BUTTON RELEASING THE SUTURE AND THE SUTURE CAME LOOSE FROM THE DEVICE AS HE RETRACTED EVERYTHING. IT APPEARED AS IF THE CLOSURE WAS NOT SUCCESSFUL AND PRESSURE WAS HELD ON THE ACCESS SITE TO OBTAIN HEMOSTASIS. ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS UNSATISFACTORY. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11314651 ↗
• InjuryFeb 5, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL DEVICE DID NOT DEPLOY. THE PROCEDURE THAT WAS BEING PERFORMED WAS A LEFT HEART CATHETERIZATION (LHC). MANUAL PRESSURE WAS USED. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS KNOWN TO BE IN STABLE CONDITION. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 12JAN2021. THE STANDARD STEPS WERE TAKEN TO DEPLOY THE DEVICE AND THERE WAS NOTHING UNUSUAL. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. HEMOSTASIS WAS ACHIEVED BY MANUAL PRESSURE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11287475 ↗
• InjuryNov 16, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE 5FR CORDIS SHEATH WAS USED FOR A DIAGNOSTIC PROCEDURE WHEN THE PHYSICIAN ATTEMPTED TO LOCATE THE ARTERIOTOMY THE ANGIO-SEAL ARTERIOTOMY LOCATOR DID NOT RETURN A STEADY STREAM TO INDICATE TRUE ENTRY INTO THE LUMEN OF THE COMMON FEMORAL ARTERY (CFA). THE DEVICE WAS INSERTED TO THE HUB AND STILL THE RETURN WAS DRIPS. THE DEVICE WAS REMOVED, AND THE ALIGNMENT OF THE DILATOR AND SHEATH WERE CONFIRMED, AND HOLES CONFIRMED. A 6/7FR MYNX WAS USED TO CLOSE THE SITE. NO COMPLICATIONS NOTED. THE PHYSICIAN DID NOTE THAT THE PATIENT'S BMI WAS HIGH. DIAGNOSTIC ANGIOGRAM WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS SENT TO RECOVERY. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10848053 ↗
• MalfunctionOct 19, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE PHYSICIAN EXPERIENCED AN UNKNOWN DEPLOYMENT ISSUE WHEN USING THE ANGIO-SEAL DEVICE. THE PHYSICIAN TRIED A SECOND ANGIO-SEAL DEVICE ON THE SAME PATIENT AND HAD THE SAME DEPLOYMENT ISSUE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 30SEPT2020. THE TYPE OF PROCEDURE PERFORMED WAS A PERCUTANEOUS CORONARY INTERVENTION USING A 6FR PROCEDURAL SHEATH. AN ANGIOGRAM WAS PERFORMED. THE ANCHOR AND COLLAGEN DID NOT DEPLOY. HEMOSTASIS WAS ACHIEVED BY MANUAL COMPRESSION. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10701336 ↗
• InjuryOct 19, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE PHYSICIAN EXPERIENCED AN UNKNOWN DEPLOYMENT ISSUE WHEN USING THE ANGIO-SEAL DEVICE. THE PHYSICIAN TRIED A SECOND ANGIO-SEAL DEVICE ON THE SAME PATIENT AND HAD THE SAME DEPLOYMENT ISSUE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 30SEPT2020. THE TYPE OF PROCEDURE PERFORMED WAS A PERCUTANEOUS CORONARY INTERVENTION USING A 6FR PROCEDURAL SHEATH. AN ANGIOGRAM WAS PERFORMED. THE ANCHOR AND COLLAGEN DID NOT DEPLOY. HEMOSTASIS WAS ACHIEVED BY MANUAL COMPRESSION. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10701274 ↗
• MalfunctionOct 16, 2020Material Frayed; Material Frayed

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL DEVICE DID NOT LOCK THE FOOTPLATE IN PLACE AS THE SECOND CLICK WOULD NOT ENGAGE, HOWEVER, THEY CONTINUED TO DEPLOY THE DEVICE, AND A FRAYED SUTURE WAS ALSO NOTED. THE PATIENT REMAINED IN STABLE CONDITION WITH NO SIGNS OF BLEED OR HEMATOMA. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 24SEPT2020. THE PROCEDURE PERFORMED PRIOR TO THE USE OF THE ANGIO-SEAL DEVICE WAS A TAVR PROCEDURE. A 6FR PROCEDURAL SHEATH WAS USED. INSERTION OF THE DEVICE WAS NOT NOTABLE, HOWEVER THE ANCHOR FAILED TO LOCK IN PLACE. HEMOSTASIS WAS ACHIEVED WITH THE REPORTED PRODUCT DEVICE, AND WITH ASSISTED MANUAL (PROPHYLACTIC) COMPRESSION. MANUAL COMPRESSION WAS PERFORMED NOT IN RESPONSE TO BLEEDING, BUT DUE TO THE UNCERTAINTY. ADDITIONAL INFORMATION WAS RECEIVED ON 30SEPT2020. THE VESSEL DIAMETER WAS GREATER THAN 5MM, NO CALCIFICATION OR ATHEROSCLEROTIC DISEASE NOTED. THE ACCESS WAS UNCOMPLICATED, A 5FR MICRO-PUNCTURE AND ULTRASOUND GUIDED ACCESS WERE USED. THE DEVICE ANCHOR DID NOT APPEAR TO LOCK IN PLACE, AS THE SECOND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10693130 ↗
• MalfunctionOct 16, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL DEVICE DID NOT LOCK THE FOOTPLATE IN PLACE AS THE SECOND CLICK WOULD NOT ENGAGE, HOWEVER, THEY CONTINUED TO DEPLOY THE DEVICE, AND A FRAYED SUTURE WAS ALSO NOTED. THE PATIENT REMAINED IN STABLE CONDITION WITH NO SIGNS OF BLEED OR HEMATOMA. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 24SEPT2020. THE PROCEDURE PERFORMED PRIOR TO THE USE OF THE ANGIO-SEAL DEVICE WAS A TAVR PROCEDURE. A 6FR PROCEDURAL SHEATH WAS USED. INSERTION OF THE DEVICE WAS NOT NOTABLE, HOWEVER THE ANCHOR FAILED TO LOCK IN PLACE. HEMOSTASIS WAS ACHIEVED WITH THE REPORTED PRODUCT DEVICE, AND WITH ASSISTED MANUAL (PROPHYLACTIC) COMPRESSION. MANUAL COMPRESSION WAS PERFORMED NOT IN RESPONSE TO BLEEDING, BUT DUE TO THE UNCERTAINTY. ADDITIONAL INFORMATION WAS RECEIVED ON 30SEPT2020. THE VESSEL DIAMETER WAS GREATER THAN 5MM, NO CALCIFICATION OR ATHEROSCLEROTIC DISEASE NOTED. THE ACCESS WAS UNCOMPLICATED, A 5FR MICRO-PUNCTURE AND ULTRASOUND GUIDED ACCESS WERE USED. THE DEVICE ANCHOR DID NOT APPEAR TO LOCK IN PLACE, AS THE SECOND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10693128 ↗
• InjuryOct 15, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL EVOLUTION DEVICE DEPLOYMENT FAILED. THE PATIENT WAS IN GOOD CONDITION. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 30SEPTEMBER2020: A PRE DEPLOYMENT ANGIOGRAM WAS PERFORMED. NO EQUIPMENT OR OTHER DEVICES USED WITH THE REPORTED PRODUCT. PATIENT CONDITION WAS STABLE. HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION. ADDITIONAL INFORMATION WAS RECEIVED ON 01OCTOBER2020: THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10686518 ↗
• MalfunctionJul 15, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT WHEN THEY OPENED THE 6FR ANGIO-SEAL DEVICE PACK DURING A PROCEDURE THE TIP OF THE DEVICE WAS KINKED. THE WHITE TUBE WAS KINKED RIGHT ON TOP OF THE COMPACTED ANCHOR. THEY USED THE PRODUCT AND HAD NO PROBLEM DURING THE DEPLOYMENT. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS POSITIVE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 19JUN2020. THE PROCEDURE BEING PERFORMED WAS A PERIPHERAL ARTERY DISEASE (PAD) ATHERECTOMY PROCEDURE USING A 6FR PROCEDURAL SHEATH. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10276893 ↗
• MalfunctionJul 10, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL SHEATH KINKED UPON INSERTION. THE CASE WAS A LEFT HEART CATHETERIZATION (LHC). A SECOND ANGIO-SEAL DEVICE WAS ATTEMPTED AND HAD THE SAME ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH MANUAL PRESSURE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10259902 ↗
• InjuryJul 10, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL SHEATH KINKED UPON INSERTION. THE CASE WAS A LEFT HEART CATHETERIZATION (LHC). A SECOND ANGIO-SEAL DEVICE WAS ATTEMPTED AND HAD THE SAME ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH MANUAL PRESSURE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10259854 ↗
• InjuryJul 10, 2020Difficult to Insert; Material Deformation; Physical Resistance/Sticking; Difficult to Insert; Material Deformation; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT RESISTANCE WAS MET INSERTING THE INVOLVED ANGIO-SEAL DEVICE SHEATH. UPON REMOVAL, THE SHEATH HAD A CRIMP IN DISTAL PORTION. MANUAL PRESSURE WAS PERFORMED. THE PATIENT'S CONDITION WAS STABLE. THE BLOOD LOSS WAS LESS THAN 250CC. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 22JUN2020. THE PROCEDURE PERFORMED FOR THE PATIENT PRIOR TO USE OF THE DEVICE WAS A LEFT HEART CATHETERIZATION (LHC). A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THERE WERE ISSUES TRYING TO INSERT THE DEVICE SHEATH.

  Patient problems: Blood Loss

  MAUDE report 10258082 ↗
• InjuryJul 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE DOCTOR WENT TO DEPLOY THE ANGIO-SEAL DEVICE ON A PATIENT AFTER AN ANGIOGRAM WAS DONE OF THE COMMON FEMORAL ARTERY AND CLOSURE WAS INDICATED. THE DOCTOR LOCATED THE VESSEL APPROPRIATELY AND INSERTED THE ANGIO-SEAL DEVICE. UPON RETRACTION OF THE DEVICE TO SEAL THE VESSEL, THE ANGIO-SEAL CAME ALL THE WAY OUT OF THE SKIN TRACT. AFTER INSPECTION OF THE DEVICE IT SEEMED AS IF THE SUTURE BROKE AT THE ANCHOR POINT AND THE ANCHOR REMAINED IN THE VESSEL WHILE THE SUTURE AND COLLAGEN PLUG WAS RECOVERED ON THE OUTSIDE OF THE SKIN TRACT. THE DOCTOR HELD MANUAL PRESSURE TO ACHIEVE HEMOSTASIS. THE PATIENT SEEMED TO TOLERATE THIS OK AND WAS DISCHARGED LATER THAT EVENING. THE PROCEDURE WAS A PERIPHERAL INTERVENTION USING A 6FR PINNACLE SHEATH AND EXCHANGED FOR A 6FR DESTINATION 45CM SHEATH. THE VESSEL WAS NORMAL AT THE COMMON FEMORAL ARTERY (CFA). A 6FR ANGIO-SEAL WAS ATTEMPTED. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS UNSATISFACTORY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10256173 ↗