ANGIO-SEAL C610135Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00389701011776), received between Aug 31, 2017 and Feb 1, 2022 — classified as 15 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (5 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2022Break; Break

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL DEVICE HAD DISINTEGRATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13419927 ↗
• MalfunctionOct 20, 2021Break; Break

  THE USER FACILITY REPORTED THAT UPON THE ANGIO-SEAL DEPLOYMENT THE SUTURE BROKE WHEN THE PHYSICIAN WAS PULLING BACK. THE PLUG DEPLOYED OK, AND NO INJURY WAS REPORTED. THE CASE WAS A VALVULOPLASTY. THERE WERE NO ISSUES REPORTED WITH ACCESS OR INSERTION OF ANGIO-SEAL DEVICE. A GROIN SHOT WAS PERFORMED. PATIENT IS KNOWN TO BE IN STABLE CONDITION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED 29SEPTEMBER2021: A 8FR SHEATH WAS USED. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. HEMOSTASIS WAS ACHIEVED BY THE ANGIO-SEAL AND MANUAL PRESSURE. THERE WAS NO BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12668673 ↗
• MalfunctionOct 14, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  THE USER FACILITY REPORTED WHEN DEPLOYING THE ANGIO-SEAL DEVICE IN THE RIGHT COMMON FEMORAL ARTERY AFTER AN ILIAC ARTERY INTERVENTION, AFTER THE DEVICE DEPLOYED A PIECE OF THE PLASTIC OF THE PRODUCT CAME LOOSE. IT DID NOT PREVENT A GOOD CLOSURE. THE PATIENT WAS IN STABLE CONDITION. A 7 FR. DESTINATION SHEATH WAS USED. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED 29SEPTEMBER2021: THE PIECE THAT CAME LOOSE IS AT THE TOP OF THE TAMP TUBE ON THE EVOLUTION. THERE WERE NO DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. PRE DEPLOYMENT ANGIOGRAM WAS PERFORMED. NO ISSUES WITH INSERTION, DEPLOYMENT, OR WITHDRAWAL OF THE DEVICE. HEMOSTASIS WAS CONFIRMED TO BE COMPLETED WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12634690 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE PATIENT WAS IN FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WORK UP. THE PATIENT HAD PAIN ON DISCHARGE IN GROIN AREA. NEXT DAY THE PATIENT WAS SWOLLEN AND BRUISED IN GROIN AREA. ON (B)(6) 2021 THE PATIENT FELT TINGLING AND NUMBNESS IN HIS LEG, SO THEY WENT INTO THE HOSPITAL AND HAD A 4CM PSEUDOANEURYSM. THE PHYSICIAN FELT THAT THE PLATE AND PLUG CAME SEPARATED, HOWEVER, THE PATIENT DID NOT REPORT FEELING ANY POP. THE PATIENT IS BEING FOLLOWED FOR POSSIBLE INTERVENTION IN THE FUTURE, HOWEVER THE PATIENT IS KNOWN TO BE STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 14SEPT2021. A 7FR PROCEDURAL SHEATH WAS USED. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED WITH THE ANGIO-SEAL DEVICE. TESTING PERFORMED TO DIAGNOSE THE PSEUDOANEURYSM WAS AN ULTRASOUND (US). THE TYPE OF INTERVENTION PERFORMED WAS A THROMBIN INJECTION.

  Patient problems: Bruise/Contusion; Numbness; Pseudoaneurysm; Swelling/ Edema

  MAUDE report 12584142 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL 8FR EVOLUTION SHEATH SHATTERED DURING DEPLOYMENT. PER THE PHYSICIAN 2/3 OF SHEATHS WERE LEFT IN ARTERY IN PIECES. THE PATIENT WAS SENT TO SURGERY TO REMOVE PIECES OF THE SHEATH. THE PATIENT CONDITION WAS GOOD. PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 26AUGUST2021: PROCEDURE PERFORMED FOR THE PATIENT PRIOR TO USE OF THE CLOSURE DEVICE WAS A PVC ABLATION. THE SHEATH SIZE USED WAS AN 8FR. THERE WERE NO DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. A PRE DEPLOYMENT ANGIOGRAM PERFORMED. ANGIO-SEAL SHEATH AND ARTERIOTOMY LOCATOR WERE ASSEMBLED AS RECOMMENDED WITHOUT INDICATION OF AN ISSUE, DEVICES WAS INSERTED, AND IT BROKE APART UPON INSERTION WHICH CAUSED FRAGMENTS TO BE LEFT IN ARTERY AND COMPLICATED REMOVAL OF DEVICE. PATIENT WAS IN STABLE CONDITION. HEMOSTASIS WAS ACHIEVED WITH A FEMSTOP TO OPERATING ROOM FOR CUTDOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 12492005 ↗
• MalfunctionSep 17, 2021Material Fragmentation; Material Fragmentation

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL 8FR DEVICE SHATTERED EASILY WITH SLIGHT PRESSURE ON THE PACKAGING. ADDITIONAL INFORMATION WAS RECEIVED ON 24AUGUST2021: THE HEMOSTASIS SHEATH SHATTERED UPON OPENING. THIS WAS DISCOVERED BEFORE ANY PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12491669 ↗
• MalfunctionSep 17, 2021Material Fragmentation; Material Fragmentation

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL 8FR DEVICE SHATTERED EASILY WITH SLIGHT PRESSURE ON THE PACKAGING. ADDITIONAL INFORMATION WAS RECEIVED ON 24AUGUST2021: THE HEMOSTASIS SHEATH SHATTERED UPON OPENING. THIS WAS DISCOVERED BEFORE ANY PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12491581 ↗
• MalfunctionSep 17, 2021Material Fragmentation; Material Fragmentation

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL 8FR DEVICE CRUMBLED IN PACKAGING PRIOR TO OPENING DEVICE. ADDITIONAL INFORMATION WAS RECEIVED ON 24AUGUST2021: THE HEMOSTASIS SHEATH SHATTERED UPON OPENING. THIS WAS DISCOVERED BEFORE ANY PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12491514 ↗
• MalfunctionMay 3, 2021Crack; Crack

  THE USER FACILITY REPORTED THAT THE PLASTIC DID NOT DEPLOY FROM THE ANGIO-SEAL DEVICE AND THE TIP CRACKED. THE PROCEDURE BEING PERFORMED WAS A NEUROVASCULAR PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 08APR2021. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11766553 ↗
• MalfunctionApr 11, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT DURING A LOWER EXTREMITY ANGIOGRAM THE ANGIO-SEAL DEVICE DID NOT DEPLOY. AN ULTRASOUND WAS NOT USED, AND IT IS UNSURE IF GROIN ANGIOGRAM WAS DONE PRIOR TO DEPLOYMENT. THE ACCESS SIDE WAS NOT PROVIDED. A SECOND ANGIO-SEAL DEVICE FROM THE SAME LOT WAS USED SUCCESSFULLY. THE PATIENT WAS STABLE, AND THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED ON 19MAR2021. A 6FR PROCEDURAL SHEATH WAS USED. THE PROPER STEPS PER THE IFU WAS TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646721 ↗
• InjuryDec 28, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT WHEN DEPLOYING THE 8FR ANGIO-SEAL EVOLUTION AFTER A FAILED PERCLOSE ATTEMPT, THE DEVICE AND SHEATH COMPONENTS WOULD NOT LOCK TOGETHER. WHEN THEY PULLED BACK, THE ENTIRE DEVICE CAME OUT. MANUAL PRESSURE WAS HELD. THE PATIENT'S CONDITION WAS STABLE. THE PROCEDURE WAS COMPLETED AS INTENDED. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON 14DEC2020. THE PROCEDURE WAS A LEFT HEART CATHETERIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077847 ↗
• InjuryNov 24, 2020Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT AFTER A PERIPHERAL INTERVENTION CONSISTING OF ORBITAL ATHERECTOMY VIA CSI AND PTA WITH MEDTRONIC AND METACROSS 6MMX200 OTW BALLOON. THE DOCTOR ATTEMPTED TO CLOSE HIS ANTEGRADE ACCESS (7 FRENCH ANSEL SHEATH) WITH AN 8FR ANGIO-SEAL. HE PERFORMED THE PROPER TECHNIQUE TO IDENTIFY HIS ARTERIOTOMY ESTABLISHING THE PROPER LOCATION. HE PERFORMED HIS SHEATH EXCHANGE FOR AN 8FR ANGIO-SEAL SUCCESSFULLY. UPON ATTEMPTING TO CONNECT THE ANGIO-SEAL TO THE ANGIO-SEAL SHEATH HE MET RESISTANCE 3/4 OF THE WAY DOWN THE ANGIO-SEAL SHEATH WHICH PREVENTED FULL ENGAGEMENT AND/OR (FIRST CLICK). THE DEVICE WOULD NOT CLICK TOGETHER. PHYSICIAN WAS ADVISED TO REMOVE DEVICE AND HOLD PRESSURE. UPON POST PROCEDURE CONVERSATIONS WITH THE PHYSICIAN IDENTIFIED THAT THE ANGLE OF INSERTION WAS STEEPER THAN 45 DEGREES. THERE WAS NO PATIENT INJURY WAS REPORTED. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS A SUCCESS. MANUAL PRESSURE WAS HELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10890394 ↗
• MalfunctionOct 16, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL FOOTPLATES ON TWO DEVICES WOULD NOT DEPLOY. THE PROCEDURE BEING PERFORMED PRIOR TO THE USE OF THE ANGIO-SEAL DEVICE WAS A LEFT HEART CATHETERIZATION (LHC). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW ANGIO-SEAL DEVICE. THERE WAS NO HARM TO THE PATIENT REPORTED AND THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 22SEPT2020. THE TWO OCCURRENCES WERE CONFIRMED TO BE DURING THE CASE WITH THE SAME PATIENT. AN 8FR PROCEDURAL SHEATH WAS USED. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. NEW ANGIO-SEAL DEVICES WERE USED TO SUCCESSFULLY OBTAIN HEMOSTASIS FOR BOTH DEPLOYMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10693129 ↗
• MalfunctionOct 16, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL FOOTPLATES ON TWO DEVICES WOULD NOT DEPLOY. THE PROCEDURE BEING PERFORMED PRIOR TO THE USE OF THE ANGIO-SEAL DEVICE WAS A LEFT HEART CATHETERIZATION (LHC). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW ANGIO-SEAL DEVICE. THERE WAS NO HARM TO THE PATIENT REPORTED AND THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 22SEPT2020. THE TWO OCCURRENCES WERE CONFIRMED TO BE DURING THE CASE WITH THE SAME PATIENT. AN 8FR PROCEDURAL SHEATH WAS USED. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. NEW ANGIO-SEAL DEVICES WERE USED TO SUCCESSFULLY OBTAIN HEMOSTASIS FOR BOTH DEPLOYMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10693127 ↗
• MalfunctionFeb 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER FACILITY REPORTED AN UNKNOWN ISSUE WITH AN ANGIO-SEAL EVOLUTION DEVICE.

  Patient problems: No Information

  MAUDE report 9714201 ↗
• InjuryDec 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT WHEN THE ANGIO-SEAL EVOLUTION FOIL PACKET WAS OPENED, THE FOOT WAS DETACHED. THEY BELIEVE THE BYPASS TUBE PROBABLY FELL OFF. A SECOND DEVICE WAS OPENED, AND IT WAS DEPLOYED SUCCESSFULLY. THE PATIENT WAS UNHARMED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SECOND ANGIO-SEAL DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9419151 ↗
• MalfunctionSep 18, 2019Component Missing; Component Missing

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL EVOLUTION DEVICE WAS MISSING THE BYPASS TUBE. THE STAFF OPENED ANOTHER 8FR ANGIO-SEAL AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS IN GOOD CONDITION AND WAS UNHARMED. THE BLOOD LOSS WAS LESS THAN 250CC'S. ADDITIONAL INFORMATION WAS RECEIVED ON 29AUG2019. THE PROCEDURE PERFORMED WAS A PERIPHERAL ATHERECTOMY USING A 7FR. SHEATH.

  Patient problems: Blood Loss

  MAUDE report 9083788 ↗
• InjurySep 6, 2019Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL SHEATH KINKED WHILE TRYING TO DEPLOY THE PLUG, WHICH IN TURN PLUGGED THE SHEATH. THE PATIENT'S CONDITION WAS STABLE, AND THE PROCEDURE OUTCOME WAS A SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED ON 21AUG2019. THE PROCEDURE THAT WAS BEING PERFORMED WAS A PERIPHERAL ANGIOPLASTY AND A 7FR PROCEDURE SHEATH SIZE WAS USED. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED, AND EVERYTHING LOOKED GOOD. WHEN THE ACTUAL ANGIO-SEAL WAS PUT INTO THE ANGIO-SEAL SHEATH, IT SEEMED TO BEND AND THEY WERE UNABLE TO PASS ANYTHING THROUGH THE SHEATH, NOT EVEN A WIRE. MANUAL PRESSURE WAS HELD FOR HEMOSTASIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8971640 ↗
• InjuryJul 16, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT. THE EVENT DESCRIPTION STATES: THE ANGIO-SEAL DEVICE FAILED, IT DID NOT DEPLOY APPROPRIATELY. THERE WAS NO HARM TO THE PATIENT. MANUAL PRESSURE WAS APPLIED TO ACHIEVE HEMOSTASIS. ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 28, 2019. THE PROCEDURE WAS A BALLOON ANGIOPLASTY, STENT PLACEMENT AND ARTERIOGRAM. THERE WAS MINIMAL BLOOD LOSS, LESS THAN 250CC.

  Patient problems: Blood Loss

  MAUDE report 8794122 ↗
• InjuryJun 28, 2019Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT AN 8F EVOLUTION DEVICE WAS USED DURING A CAROTID FEMORAL ACCESS CASE. THE FOOTPLATE DID NOT COME OUT, AND MANUAL PRESSURE WAS APPLIED TO COMPLETE THE CASE SUCCESSFULLY.

  Patient problems: No Information

  MAUDE report 8743634 ↗
• InjuryMar 12, 2019Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT THE DOCTOR DEPLOYED THE ANGIO-SEAL EVOLUTION IN THE RIGHT GROIN. WHEN THE DOCTOR WENT TO RELEASE THE SUTURE THE ENTIRE DEVICE CAME OUT WITH THE COLLAGEN, ANCHOR AND SUTURE. THEY HELD MANUAL COMPRESSION AFTERWARDS. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2019. THE PHYSICIAN PERFORMED ANGIOGRAM PRE-DEPLOYMENT. THE SHEATH SIZE WAS A 8FR. THE PROCEDURE WAS A NERUO CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8414292 ↗
• MalfunctionJan 17, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE USER FACILITY REPORTED THAT AN EXPIRED ANGIO-SEAL DEVICE WAS DEPLOYED DURING A PCI (PERCUTANEOUS CORONARY INTERVENTION) PROCEDURE. THE BOX AND PACKAGE WERE CORRECTLY LABELED. THE PATIENT HAS NOT PRESENTED ANY PROBLEMS. THE HEALTH CARE PROVIDER WHO DEPLOYED THE DEVICE DID NOT DETECT ANY ISSUES DURING THE DEPLOYMENT. THE PATIENT'S CONDITION WAS REPORTED TO BE GOOD THE NEXT DAY DURING A FOLLOW UP. THE PATIENT WAS STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE ANGIO-SEAL DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8256242 ↗
• InjuryOct 31, 2018Material Fragmentation; Material Fragmentation

  THE USER FACILITY REPORTED THEY WERE CLOSING A FEMORAL ARTERY ARTERIOTOMY SITE WITH AN 8FR ANGIO-SEAL EVOLUTION. WHILE ATTEMPTING TO DEPLOY THE DEVICE, THE ANGIO-SEAL SHEATH FRACTURED INTO MANY SMALL PIECES. IT WAS REPORTED THAT THE ANGIO-SEAL SHEATH WAS VERY BRITTLE AND ESSENTIALLY DISINTEGRATED. THEY ATTEMPTED TO REMOVE ALL THE FRACTURED PIECES OF DEVICE, HOWEVER THEY ARE UNCERTAIN IF THEY WERE ABLE TO EXTRACT ALL THE DEVICE FRAGMENTS FROM THE PATIENT .THE PROCEDURE WAS COMPLETED WITH MANUAL COMPRESSION. ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 23, 2018: IT WAS REPORTED THAT THE FRACTURED PIECES WERE REMOVED BY HAND AND IT APPEARED THEY WERE ABLE TO REMOVE ALL OF IT. IMAGING SHOWED NO APPARENT SIGN OF THE PRODUCT FRAGMENTS LEFT IN THE PATIENT. THE HOSPITAL DID ADDITIONAL IMAGING AND KEPT THE PATIENT OVERNIGHT TO TRY TO MAKE SURE THERE WEREN'T ANY COMPLICATIONS AND NO VISIBLE FRAGMENTS WERE PRESENT. AFTER TAKING THE PRECAUTIONS THE HOSPITAL DECIDED IT WAS SAFE TO DISCHARGE THE PATIENT AND DID NOT FEEL THE ANGIO-SEAL FRAGMENTS WERE PRESENT. NO OTHER EQUIPMENT WAS USED WITH THE ANGIO-SEAL DEVICE.

  Patient problems: No Information

  MAUDE report 8024445 ↗
• MalfunctionAug 24, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT WHEN THE ANGIO-SEAL DEVICE WAS REMOVED FROM THE PACKAGING, THE COLLAGEN WAS ALREADY VISIBLE AND OUT OF THE BYPASS TUBE. A NEW ANGIO-SEAL FROM THE SAME LOT NUMBER WAS OPENED AND WAS DEPLOYED SUCCESSFULLY. IT WAS A COMPLEX CORONARY PROCEDURE. THE PATIENT WAS UNHARMED AS THE DEVICE DID NOT TOUCH THE PATIENT. NO OTHER EQUIPMENT OR DEVICES WERE BEING USED WITH THE ANGIO-SEAL DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7812259 ↗
• MalfunctionJun 27, 2018Break; Break

  THE USER FACILITY REPORTED THAT THE SUTURE WERE NOT ATTACHED TO THE ANGIO-SEAL DEVICE. THE PATIENT WAS STABLE AND THE PULSES WERE GOOD. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018: IT WAS REPORTED THAT THEY WERE TREATING PERIPHERAL VASCULAR DISEASE. THE DOCTOR SAID WHEN HE WENT TO PULL BACK THE DEVICE HE NOTED THE SUTURE WAS NOT ATTACHED. THE DOCTOR QUICKLY GRABBED THE SUTURE AND MANUALLY TIGHTENED IT DOWN. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED BY THE ANGIO-SEAL ONCE THE DOCTOR MANUALLY TIGHTENED IT. THERE WAS NO REPORTED BLOOD LOSS. THE PROCEDURE WAS SUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7642068 ↗