Angio-Seal™ Evolution™ (REF C610134)Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 05415067002839), received between Apr 21, 2017 and Oct 3, 2018 — classified as 35 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (13 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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2018Activation, Positioning or Separation Problem

  DOCTOR REPORTED THE ANGIO-SEAL DEVICE FAILED TO DEPLOY. THEY ALSO NOTED A KNOWN 5% FAILURE RATE WITH THIS DEVICE. THERE WAS NO OPERATOR ERROR ISSUE, STRICTLY A FAULTY DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7929422 ↗
• MalfunctionDec 5, 2017Difficult or Delayed Positioning; Physical Resistance; Difficult or Delayed Positioning; Physical Resistance

  THE USER FACILITY REPORTED DIFFICULTIES WITH THE INVOLVED ANGIO-SEAL EVOLUTION DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE DOCTOR USED AN ANGIO-SEAL EVOLUTION 6FR TO PERFORM A LHC DIAGNOSTIC ANGIOGRAPHY PROCEDURE FOR A CAD. DURING THE CLOSURE OF THE PUNCTURE, AND AFTER THE DOCTORS DEPLOYED THE ANCHOR, HE PULLED THE DEVICE HANDLE INTO THE FULL REAR POSITION. WHEN THE DOCTOR PRESSED THE SUTURE RELEASE BUTTON, AND PULLED BACK THE SUTURE CABLE, HE ENCOUNTERED A LOT OF TENSION AND RESISTANCE DURING THE PULLBACK. NO OUTSIDE PRESENCE OF THE ANCHOR OR COLLAGEN WAS OBSERVED. THERE WAS NO INFECTIOUS DISEASE. HEMOSTASIS WAS ACHIEVED, AND NO MANUAL PRESSURE WAS REQUIRED. THE PATIENT WAS REPORTED TO BE WELL AND WAS ALREADY DISCHARGED. THERE WERE NO REPORTED COMPLICATIONS WITH THE PROCEDURE OUTCOME. A FEMORAL INTRODUCES AND A REGULAR GUIDEWIRE WERE USED WITH THE REPORTED PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7082741 ↗
• InjuryNov 30, 2017Detachment Of Device Component; Detachment Of Device Component

  ADDITIONAL INFORMATION WAS RECEIVED ON DECEMBER 8, 2017: IT WAS REPORTED THAT HEMOSTASIS WAS NOT ACHIEVED WITH THE ANGIOSEAL. THEY WERE ABLE TO HOLD PRESSURE AND THE PATIENT SUCCESSFULLY STOPPED BLEEDING POST-OP. NO FURTHER COMPLICATIONS WERE REPORTED. IT WAS CONFIRMED THAT THEY PHYSICALLY SAW THE SAMPLE AND THAT THE ANCHOR IS STILL IN THE ANGIOSEAL SHEATH. THEREFORE, IT WAS NOT LEFT IN THE PATIENT. IT WAS REPORTED THAT THE COLLAGEN WAS NOT TAMPED DOWN AND DEPLOYED DUE TO NOT EXISTING THE SHEATH UPON APPLICATION.

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 7071154 ↗
• InjuryNov 14, 2017Positioning Failure; Positioning Failure

  THE USER FACILITY REPORTED DEPLOYMENT DIFFICULTIES WITH THE INVOLVED ANGIO-SEAL EVOLUTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE DOCTOR REPORTED THAT THE DEVICE DID NOT DEPLOY CORRECTLY. IT WAS REPORTED THAT BLOOD LOSS WAS LESS THAN 250CC. AN ALTERNATE EVOLUTION DEVICE WAS USED. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION. THE PROCEDURE OUTCOME WAS REPORTED TO BE A SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED ON NOVEMBER 8, 2017. HEMOSTASIS WAS ACHIEVED BY MANUAL PRESSURE AND THERE WAS NO OTHER EQUIPMENT OR DEVICES BEING USED WITH THE REPORTED PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7029827 ↗
• MalfunctionNov 1, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THE USER FACILITY REPORTED DEPLOYMENT DIFFICULTIES WITH THE ANGIO-SEAL EVOLUTION DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE REPORTER MENTIONED THAT PHYSICIANS ARE STATING THE BUTTON THAT RELEASES THE SUTURE SO THAT IT IS VISIBLE TO CUT IS MALFUNCTIONING. PHYSICIANS STATE THAT THE BUTTON DOES NOT DEPRESS AND THEY HAVE TO PULL VERY HARD TO EXPOSE THE SUTURE AFTER SEVERAL ATTEMPTS AT DEPRESSING THE BUTTON. IT WAS REPORTED THAT HEMOSTASIS WAS OBTAINED. THE ISSUE ALLEGEDLY LIES WITHIN THE BUTTON RELEASE. IT WAS REPORTED THAT THE PATIENT IS STABLE. THE PROCEDURE OUTCOME WAS REPORTED ADEQUATE. ADDITIONAL INFORMATION WAS RECEIVED ON 10/11/17. HEMOSTASIS WAS ACHIEVED BY THE DEVICE. THE PATIENT WAS NOT EFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6994492 ↗
• MalfunctionNov 1, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THE USER FACILITY REPORTED DEPLOYMENT DIFFICULTIES WITH THE ANGIO-SEAL EVOLUTION DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE REPORTER MENTIONED THAT PHYSICIANS ARE STATING THE BUTTON THAT RELEASES THE SUTURE SO THAT IT IS VISIBLE TO CUT IS MALFUNCTIONING. PHYSICIANS STATE THAT THE BUTTON DOES NOT DEPRESS AND THEY HAVE TO PULL VERY HARD TO EXPOSE THE SUTURE AFTER SEVERAL ATTEMPTS AT DEPRESSING THE BUTTON. IT WAS REPORTED THAT HEMOSTASIS WAS OBTAINED. THE ISSUE ALLEGEDLY LIES WITHIN THE BUTTON RELEASE. IT WAS REPORTED THAT THE PATIENT IS STABLE. HEMOSTASIS WAS ACHIEVED BY THE EVOLUTION. ADDITIONAL INFORMATION WAS RECEIVED ON 10/11/17. HEMOSTASIS WAS ACHIEVED BY THE DEVICE. THE PATIENT WAS NOT EFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6994489 ↗
• MalfunctionNov 1, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THE USER FACILITY REPORTED DEPLOYMENT DIFFICULTIES WITH THE ANGIO-SEAL EVOLUTION DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE PHYSICIANS ARE STATING THE BUTTON THAT RELEASES THE SUTURE, SO THAT IT IS VISIBLE TO CUT, IS MALFUNCTIONING; THE BUTTON DOES NOT DEPRESS AND THEY HAVE TO PULL VERY HARD TO EXPOSE THE SUTURE AFTER SEVERAL ATTEMPTS AT DEPRESSING THE BUTTON; IN THE SEVERAL EVENTS THIS OCCURRED, HEMOSTASIS WAS OBTAINED PER THE REPORTER; AND THE ISSUE ALLEGEDLY LIES WITHIN THE BUTTON RELEASE. ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 11, 2017. HEMOSTASIS WAS ACHIEVED BY THE EVOLUTION DEVICE BEING USED. THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6994464 ↗
• InjuryOct 23, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE GEAR WAS LOCKING UP WHEN TYING TO PULL BACK AND THE PLUG ACTUALLY PARTIALLY CAME OUT OF THE PATIENT. MINIMAL BLOOD LOSS WAS REPORTED. IT WAS REPORTED THAT THE PATIENT WAS IN GOOD CONDITION. IT WAS REPORTED THAT THE PROCEDURE OUTCOME WAS SUCCESSFUL. IT WAS REPORTED THAT AN ULTRASOUND WAS USED. THE CASE WAS COMPLETED WITH COMPRESSION ONLY.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 6969115 ↗
• MalfunctionOct 11, 2017Activation, Positioning or Separation Problem; Device Operates Differently Than Expected; Activation, Positioning or Separation Problem; Device Operates Differently Than Expected

  THE USER FACILITY REPORTED THAT THE SUTURE LOCK UP ON WITH THE ANGIOSEAL EVOLUTION DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER: THE PROCEDURE WENT AS SCRIPTED RIGHT UP TO THE POINT OF COLLAGEN COMPACTION. THE COMPACTION NEVER ADVANCED WHEN THE DEVICE WAS PULLED BACK UPON. THERE WAS ENOUGH PULLBACK FORCE TO TENT THE PATIENT'S SKIN AT THE ACCESS SITE BUT THE COMPACTION TUBE DIDN'T BUDGE. AT THIS POINT WE HAD TO PUSH THE SUTURE RELEASE BUTTON AND HARVEST THE COMPACTION TUBE TO MANUALLY COMPRESS THE COLLAGEN. THE CLOSURE WAS SUCCESSFUL BUT THE DEVICE DID NOT WORK AS INTENDED. IT WAS REPORTED THAT THE PATIENT CONDITION WAS STABLE. IT WAS REPORTED THAT THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6940991 ↗
• MalfunctionOct 11, 2017Difficult or Delayed Positioning; Activation, Positioning or Separation Problem; Difficult or Delayed Positioning; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE ANGIOSEAL EVOLUTION HAD FAILED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER: AFTER THE ANCHOR WAS SET, THE DOCTOR BEGAN TO PULL BACK ON THE DEVICE TO DEPLOY THE COLLAGEN AND WHILE PULLING BACK HE NOTICED THAT THERE WAS NO TAMPER TUBE AND ONLY THE SUTURE WAS PRESENT. THE DOCTOR SAID THAT THE ACCESS SITE WAS NOT BLEEDING AND THAT HE THOUGHT HE HAD HEMOSTASIS, BUT WAS UNSURE THAT THE COLLAGEN DEPLOYED CORRECTLY. THE DOCTOR CUT THE DEVICE OPEN AND WAS ABLE TO LOCATE THE TAMPER TUBE IN THE SHEATH. THE DOCTOR WAS ABLE TO MANUALLY TAMP THE COLLAGEN AND CONFIRMED THAT THERE WAS NO BLEEDING OR HEMATOMA AT THE SITE. IT WAS REPORTED THAT THE PATIENT CONDITION WAS STABLE. IT WAS REPORTED THAT THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6940981 ↗
• InjurySep 14, 2017Positioning Failure

  THE USER FACILITY REPORTED THAT THE DEVICE DIDN'T DEPLOY. IT WAS REPORTED THAT THE PATIENT WAS FINE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2017: IT WAS REPORTED THAT HEMOSTASIS WAS ACHIEVED BY MANUAL COMPRESSION AND THE BLOOD LOSS WAS LESS THAN 250CC. THE PATIENT IS STABLE. THE PROCEDURE OUT COME WAS SUCCESSFUL.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 6866003 ↗
• MalfunctionSep 8, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL EVOLUTION SHEATH EXCHANGED FOR VESSEL LOCATOR SHEATH. VCD ADVANCED THROUGH ANGIOSEAL SHEATH. ANCHOR SET. IT WAS REPORTED THAT UPON RETRACTION OF THE DEVICE RESISTANCE WAS FELT. THE PHYSICIAN APPLIED AS MUCH FORCE AS DEEMED SAFE WITH NO MOVEMENT OF THE DEVICE. THE PHYSICIAN CUT THE PLASTIC TUBE AT THE PROXIMAL PORTION OF THE DEVICE, REMOVED THE HANDLE AND TAMPED MANUALLY. IMMEDIATE HEMOSTASIS WAS ACHIEVED. IT WAS REPORTED THAT THE PATIENT HAD NO COMPLICATIONS RELATED TO THE DEVICE FAILURE. IT WAS REPORTED THAT THE BLOOD LOSS WAS LESS THAN 250 CC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6851719 ↗
• InjurySep 7, 2017Break; Break

  THE USER FACILITY REPORTED THAT THEY USED AN ANGIO-SEAL EVOLUTION 6FR TO PERFORM A DIAGNOSTIC ANGIOGRAPHY PROCEDURE IN THE CATH LAB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: DURING THE CLOSURE OF THE PUNCTURE AND AFTER THE DOCTORS DEPLOY THE ANCHOR, THE DOCTOR PULLED THE DEVICE HANDLE INTO FULL REAR POSITION AND THE SLEEVE SNAP LOCKED. WHEN THE DOCTOR PRESSED THE SUTURE RELEASE BUTTON AND PULLBACK, THE SUTURE CABLE BROKE. HEMOSTASIS WAS ACHIEVED WITH MANUAL PRESSURE. IT WAS REPORTED THAT THERE WAS NO SURGICAL INTERVENTION REQUIRED, NO COMPLICATIONS, AND NO INFECTIOUS DISEASE REPORTED. PATIENT OBSERVATION DURING THE FOLLOWING HOURS. FEMORAL INTRODUCER AND REGULAR GUIDE WIRE WERE USED WITH THE REPORTED PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6849247 ↗
• InjurySep 6, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE ANGIOSEAL EVOLUTION MECHANISM WAS STUCK AND DID NOT DEPLOY CORRECTLY. IT WAS REPORTED THAT THE PATIENT CONDITION IS STABLE. IT WAS REPORTED THAT THE PATIENT OUTCOME WAS SUCCESSFUL. HEMOSTASIS WAS ACHIEVED BY MANUAL COMPRESSION. IT WAS REPORTED THAT THE BLOOD LOSS WAS LESS THAN 10 CC. NO SURGICAL OR MEDICAL INTERVENTION NEEDED OUTSIDE OF THE NORMAL CATH. A STANDARD IK WAS USED WITH THE PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6846127 ↗
• MalfunctionAug 23, 2017Difficult or Delayed Positioning; Physical Resistance; Difficult or Delayed Positioning; Physical Resistance

  THE USER FACILITY REPORTED THAT THE DOCTOR DEPLOYED ANGIOSEAL AND HAD A LOT OF RESISTANCE AT THE GEAR AND COULD NOT GET IT TO DEPLOY SMOOTHLY. LOTS OF RESISTANCE. THE PATIENT CONDITION WAS GOOD. IT WAS REPORTED THE PROCEDURE OUTCOME WAS GOOD AND WORKED BUT WAS NOT SMOOTH. ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 8, 2017. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. REPORTED BLOOD LOSS WAS LESS THAN 250CC. THE DEVICE WORKED, HOWEVER, IT WORKED IMPROPERLY.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 6813785 ↗
• InjuryAug 23, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE PHYSICIAN STATED THAT AFTER SETTING THE ANCHOR WHEN GOING TO PULL BACK ON THE HANDLE THAT THE TAMPER TUBE WAS NOT SLIDING DOWN AND THAT GEAR STARTED TO GRIND BEFORE THE GREEN MARKER WAS EXPOSED. HE FELT AS IF HE WAS PULLING TO HARD SO HE ABORTED AND HELD MANUAL PRESSURE ASSURING HEMOSTASIS WAS ACHIEVED. IT WAS REPORTED THAT THE PATIENT CONDITION WAS STABLE. IT WAS REPORTED THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED IN AUGUST 6, 2017. THERE WERE NO OTHER DEVICES WERE USED WITH THE REPORTED PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6813756 ↗
• InjuryAug 23, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE PHYSICIAN STATED THAT AFTER SETTING THE ANCHOR WHEN GOING TO PULL BACK ON THE HANDLE THAT THE TAMPER TUBE WAS NOT SLIDING DOWN AND THAT GEAR STARTED TO GRIND BEFORE THE GREEN MARKER WAS EXPOSED. HE FELT AS IF HE WAS PULLING TO HARD, SO HE ABORTED AND HELD MANUAL PRESSURE ASSURING HEMOSTASIS WAS ACHIEVED. IT WAS REPORTED THAT THE PATIENT CONDITION WAS STABLE. IT WAS REPORTED THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 6, 2017. THERE WERE NO OTHER DEVICES USED WITH THE REPORTED PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6813362 ↗
• InjuryAug 23, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE PHYSICIAN STATED THAT AFTER SETTING THE ANCHOR WHEN GOING TO PULL BACK ON THE HANDLE THAT THE TAMPER TUBE WAS NOT SLIDING DOWN AND THAT GEAR STARTED TO GRIND BEFORE THE GREEN MARKER WAS EXPOSED. HE FELT AS IF HE WAS PULLING TO HARD SO HE ABORTED AND HELD MANUAL PRESSURE ASSURING HEMOSTASIS WAS ACHIEVED. IT WAS REPORTED THAT THE PATIENT CONDITION WAS STABLE. IT WAS REPORTED THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 6, 2017. THERE WERE NO OTHER DEVICES BEING USED WITH THE PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6813127 ↗
• InjuryAug 9, 2017Positioning Failure; Positioning Failure

  THE USER FACILITY REPORTED A PULLOUT WHEN USING THE ANGIOSEAL DEVICE . THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: IT WAS REPORTED THAT THE FOOTPLATE AND COLLAGEN PULLED OUT DURING DEPLOYMENT. MANUAL PRESSURE WAS USED TO ACHIEVE HEMOSTASIS. PROCEDURE WAS SUCCESSFUL. THE PATIENT IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6778729 ↗
• InjuryAug 7, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE USER FACILITY REPORTED THE DEVICE CAME OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: UPON REMOVAL, WHEN PULLING THE ANGIO-SEAL DEVICE PRIOR TO RELEASING THE SUTURE, THE ENTIRE DEVICE CAME OUT; PRESSURE WAS APPLIED TO ACHIEVE HEMOSTASIS AFTER THIS OCCURRED; THE CONDITION OF THE PATIENT WAS SATISFACTORY AND FINE; AND THE PROCEDURE OUTCOME WAS SATISFACTORY AND FINE. ADDITIONAL INFORMATION WAS RECEIVED ON JULY 24, 2017. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6770716 ↗
• InjuryJul 31, 2017Detachment Of Device Component; Detachment Of Device Component

  THE USER FACILITY REPORTED DIFFICULTIES WITH THE INVOLVED ANGIO-SEAL EVOLUTION DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE ANGIO-SEAL FOOT PROCESS WAS CAUGHT DURING DEPLOYMENT; AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON JULY 14, 2017. THE ANGIO-SEAL FOOT PROCESS GOT CAUGHT AND THE DEVICE BROKE INSIDE THE VESSEL. THE FOOT PROCESS WAS RETAINED INSIDE THE COMMON FEMORAL ARTERY. THE COLLAGEN PLUG WAS NOT DEPLOYED. THE PATIENT WAS MONITORED OVERNIGHT IN THE HOSPITAL AND NO ADVERSE RESULTS HAVE BEEN NOTICED THUS FAR.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6755039 ↗
• InjuryJul 24, 2017Positioning Failure; Component Missing; Positioning Failure; Component Missing

  THE USER FACILITY REPORTED ANTEGRADE STICK WITH THE INVOLVED ANGIO-SEAL EVOLUTION DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: WHEN IT WAS DEPLOYED THERE WAS NOTHING IN IT, SUTURE, COLLAGEN OR FOOTPLATE. MANUAL PRESSURE WAS HELD. IT WAS REPORTED THE PATIENT WAS IN GOOD CONDITION. PROCEDURE OUTCOME WAS GOOD. ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 6737089 ↗
• MalfunctionJul 14, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED: PAD CASE, ACCESSED RIGHT FEMORAL ARTERY, TREATED CONTRALATERALLY. BALLOON ANGIOPLASTY OF RIGHT SFA, FOLLOWED BY DRUG-ELUDING BALLOON AND STENT. DEVICE DID NOT DEPLOY PROPERLY. PHYSICIAN WAS UNABLE TO SEE THE GREEN MARKER ON THE SUTURE AND WAS UNSURE IF COLLAGEN WAS ADVANCED ENOUGH TO SEAL THE ARTERY AGAINST THE ANCHOR. THE PATIENT IS STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 6/16/17. THE DEVICE WAS ABLE TO SEAL THE ARTERY, SO THE ANCHOR, SUTURE AND COLLAGEN ARE IN THE PATIENT. HEMOSTASIS WAS ACHIEVED BY THE DEVICE AND THE BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 6714138 ↗
• InjuryJul 3, 2017Component Missing; Component Missing

  THE USER FACILITY REPORTED A MISSING COMPONENT WHEN USING THE ANGIO SEAL DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE PHYSICIAN ATTEMPTED TO DEPLOY THE ANGIO SEAL DEVICE AND THE SUTURE DID NOT APPEAR TO BE PRESENT. MANUAL PRESSURE WAS HELD AT THE PUNCTURE SITE POST DEVICE FAILURE. THERE WERE NO COMPLICATIONS AND THE PATIENT IS STABLE. THE PROCEDURE WAS A SUCCESSFUL PCI. THE REPORTED BLOOD LOSS WAS LESS THAN 250CC'S.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 6684152 ↗
• InjuryJul 3, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE USER FACILITY REPORTED PULLOUT WITH THE INVOLVED ANGIO-SEAL EVOLUTION DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE CUSTOMER STATED THAT DURING DEPLOYMENT, THE DEVICE (INCLUDING THE ANCHOR) PULLED DIRECTLY OUT OF THE BODY; HEMOSTASIS WAS ACHIEVED BY MANUAL COMPRESSION; THE BLOOD LOSS WAS ESTIMATED TO BE APPROXIMATELY 10 CC'S; THE PATIENT WAS REPORTED TO BE STABLE; AND THERE WAS NO OTHER EQUIPMENT OR DEVICES BEING USED WITH THE REPORTED PRODUCT.

  Patient problems: Blood Loss; No Known Impact Or Consequence To Patient

  MAUDE report 6684130 ↗