ANGIO-SEAL 610119Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00389701011868), received between Nov 20, 2017 and Aug 13, 2020 — classified as 26 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (15 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 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2020Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  THE USER FACILITY REPORTED THAT THE INVOLVED ANGIO-SEAL DEVICE WAS STUCK IN THE ANGIO-SEAL SHEATH. THE ANGIO-SEAL CAME ALL THE WAY OUT. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. THE PATIENT'S CONDITION WAS STABLE, NO ISSUES. 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 27JUL2020. BOTH OCCURRENCES HAPPENED ON THE SAME PATIENT. THE PROCEDURE WAS PERIPHERAL ANGIOGRAM WITH INTERVENTION USING A 7FR SHEATH. THERE WAS DIFFICULTY ADVANCING THE ANGIO-SEAL THROUGH THE ANGIO-SEAL SHEATH; IT WAS STUCK IN THE PROXIMAL PORTION OF THE SHEATH AND REMOVED BY USING A HEMOSTAT. A PRE- DEPLOYMENT ANGIO WAS PERFORMED. MANUAL PRESSURE WAS USED, AND HEMOSTASIS WAS ACHIEVED. NO ISSUES WITH THE PATIENT WERE NOTED FROM THE ANGIO-SEAL. WHEN THE FIRST DEVICE FAILED, THE SECOND ANGIO SEAL DEVICE WAS PULLED. WHEN THE SECOND DEVICE FAILED, MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO ISSUES WITH THE PATIENT NOTED FROM THE ANGIO-SEAL DEVICE.

  Patient problems: Blood Loss

  MAUDE report 10401222 ↗
• MalfunctionAug 13, 2020Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  THE USER FACILITY REPORTED THAT THE INVOLVED ANGIO-SEAL DEVICE WAS STUCK IN THE ANGIO-SEAL SHEATH. THE ANGIO-SEAL CAME ALL THE WAY OUT. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. THE PATIENT'S CONDITION WAS STABLE, NO ISSUES. 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 27JUL2020. BOTH OCCURRENCES HAPPENED ON THE SAME PATIENT. THE PROCEDURE WAS PERIPHERAL ANGIOGRAM WITH INTERVENTION USING A 7FR SHEATH. THERE WAS DIFFICULTY ADVANCING THE ANGIO-SEAL THROUGH THE ANGIO-SEAL SHEATH; IT WAS STUCK IN THE PROXIMAL PORTION OF THE SHEATH AND REMOVED BY USING A HEMOSTAT. A PRE- DEPLOYMENT ANGIO WAS PERFORMED. MANUAL PRESSURE WAS USED, AND HEMOSTASIS WAS ACHIEVED. NO ISSUES WITH THE PATIENT WERE NOTED FROM THE ANGIO-SEAL. WHEN THE FIRST DEVICE FAILED, THE SECOND ANGIO SEAL DEVICE WAS PULLED. WHEN THE SECOND DEVICE FAILED, MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO ISSUES WITH THE PATIENT NOTED FROM THE ANGIO-SEAL DEVICE.

  Patient problems: Blood Loss

  MAUDE report 10401220 ↗
• MalfunctionJul 22, 2020Difficult to Insert; Activation, Positioning or Separation Problem; Difficult to Insert; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE INVOLVED ANGIO-SEAL DEVICE DID NOT DEPLOY PROPERLY AND WAS DIFFICULT TO GET INTO THE ARTERY. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 13JUL2020. WHEN THE PHYSICIAN HAS ENCOUNTERED THIS HE IS UTILIZING AN ADDITIONAL STIFF SUPPORT WIRE TO OBTAIN SUCCESSFUL DEPLOYMENT AND ARTERIAL CLOSURE.

  Patient problems: No Information

  MAUDE report 10308817 ↗
• MalfunctionJul 16, 2020Difficult to Insert; Activation, Positioning or Separation Problem; Difficult to Insert; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE INVOLVED ANGIO-SEAL DEVICE DID NOT DEPLOY PROPERLY AND WAS DIFFICULT TO GET INTO THE ARTERY. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED 13JUL2020. WHEN THE PHYSICIAN HAS ENCOUNTERED THIS HE IS UTILIZING AN ADDITIONAL STIFF SUPPORT WIRE TO OBTAIN SUCCESSFUL DEPLOYMENT AND ARTERIAL CLOSURE.

  Patient problems: No Information

  MAUDE report 10283655 ↗
• MalfunctionJul 16, 2020Difficult to Insert; Activation, Positioning or Separation Problem; Difficult to Insert; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE INVOLVED ANGIO-SEAL DEVICE DID NOT DEPLOY PROPERLY AND WAS DIFFICULT TO GET INTO THE ARTERY. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED 13JUL2020. WHEN THE PHYSICIAN HAS ENCOUNTERED THIS HE IS UTILIZING AN ADDITIONAL STIFF SUPPORT WIRE TO OBTAIN SUCCESSFUL DEPLOYMENT AND ARTERIAL CLOSURE.

  Patient problems: No Information

  MAUDE report 10283610 ↗
• MalfunctionJul 16, 2020Difficult to Insert; Activation, Positioning or Separation Problem; Difficult to Insert; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE INVOLVED ANGIO-SEAL DEVICE DID NOT DEPLOY PROPERLY AND WAS DIFFICULT TO GET INTO THE ARTERY. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED 13JUL2020. WHEN THE PHYSICIAN HAS ENCOUNTERED THIS HE IS UTILIZING AN ADDITIONAL STIFF SUPPORT WIRE TO OBTAIN SUCCESSFUL DEPLOYMENT AND ARTERIAL CLOSURE.

  Patient problems: No Information

  MAUDE report 10283603 ↗
• MalfunctionApr 10, 2020Material Twisted/Bent; Material Twisted/Bent

  THE USER FACILITY REPORTED THAT TWO ANGIO-SEAL SHEATHS WERE BENT UPON REMOVAL FROM THE PACKAGING. THE PHYSICIAN DID NOT WANT TO USE OR DEPLOY THE DEVICES FOR THE PATIENT'S SAFETY. ADDITIONAL INFORMATION WAS RECEIVED ON 17MAR2020: THE FIRST DEVICE WAS OPENED, AND THE SHEATH WAS NOTED TO BE BENT. THE DOCTOR THEN OPENED A SECOND ANGIO-SEAL DEVICE FROM THE SAME LOT NUMBER, AND IT WAS BENT RIGHT OUT OF THE PACKAGE AS WELL. A THIRD ANGIO-SEAL DEVICE WAS OPENED, AND THE PROCEDURE WAS COMPLETED WITH NO ISSUES. THERE WERE NO ISSUES FOR THE PATIENT AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9950002 ↗
• MalfunctionApr 10, 2020Material Twisted/Bent; Material Twisted/Bent

  THE USER FACILITY REPORTED THAT TWO ANGIO-SEAL SHEATHS WERE BENT UPON REMOVAL FROM THE PACKAGING. THE PHYSICIAN DID NOT WANT TO USE OR DEPLOY THE DEVICES FOR THE PATIENT'S SAFETY. ADDITIONAL INFORMATION WAS RECEIVED ON 17MAR2020. THE FIRST DEVICE WAS OPENED, AND THE SHEATH WAS NOTED TO BE BENT. THE DOCTOR THEN OPENED A SECOND ANGIO-SEAL DEVICE FROM THE SAME LOT NUMBER, AND IT WAS BENT RIGHT OUT OF THE PACKAGE AS WELL. A THIRD ANGIO-SEAL DEVICE WAS OPENED, AND THE PROCEDURE WAS COMPLETED WITH NO ISSUES. THERE WERE NO ISSUES FOR THE PATIENT AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9950000 ↗
• InjuryApr 1, 2020Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL TRANSITION ON THE SHEATH TO THE ARTERIOTOMY LOCATOR WAS SO BIG AND BULKY THEY COULD NOT GET IT INTO THE VESSEL. THEY HAD TO ABORT AND HOLD MANUAL PRESSURE. THERE WAS NO NEGATIVE PATIENT OUTCOMES OR ADDITIONAL BLEEDING. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9910336 ↗
• InjuryApr 1, 2020Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL TRANSITION ON THE SHEATH TO THE ARTERIOTOMY LOCATOR WAS SO BIG AND BULKY THEY COULD NOT GET IT INTO THE VESSEL. THEY HAD TO ABORT AND HOLD MANUAL PRESSURE. THERE WAS NO NEGATIVE PATIENT OUTCOMES OR ADDITIONAL BLEEDING. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9910144 ↗
• InjuryApr 1, 2020Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL TRANSITION ON THE SHEATH TO THE ARTERIOTOMY LOCATOR WAS SO BIG AND BULKY THEY COULD NOT GET IT INTO THE VESSEL. THEY HAD TO ABORT AND HOLD MANUAL PRESSURE. THERE WAS NO NEGATIVE PATIENT OUTCOMES OR ADDITIONAL BLEEDING. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9910142 ↗
• InjuryApr 1, 2020Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL TRANSITION ON THE SHEATH TO THE ARTERIOTOMY LOCATOR WAS SO BIG AND BULKY THEY COULD NOT GET IT INTO THE VESSEL. THEY HAD TO ABORT AND HOLD MANUAL PRESSURE. THERE WAS NO NEGATIVE PATIENT OUTCOMES OR ADDITIONAL BLEEDING. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9910141 ↗
• InjuryMar 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5092859. THE EVENT DESCRIPTION STATES: "PT UNDERWENT CARDIAC CATH WITH INTERVENTION. AFTER PROCEDURE ANGIO SEAL WAS USED TO PREVENT BLEEDING FROM RIGHT FEMORAL ARTERY STICK. WHEN PT MET CRITERIA TO GET DOB, PT COMPLAINED OF RIGHT LEG PAIN AND RIGHT FOOT NUMBNESS. NURSE EXAMINED PT. AND COULD NOT PALPATE OR DOPLER PULSE. CARDIOLOGIST NOTIFIED AND CONSULTED VASCULAR SURGEON. PT SEEN BY VASCULAR SURGEON AND IMMEDIATELY TAKEN TO THE OPERATING ROOM. PT UNDERWENT THE FOLLOWING SURGERY. RIGHT FEMORAL ARTERY EXPLORATION, THROMBECTOMY OF RIGHT COMMON FEMORAL ARTERY. EXTRACTION OF FOREIGN BODY, REPAIR OF RIGHT COMMON FEMORAL ARTERY, SAPHENOUS VEIN PATCH ANGIOPLASTY OF THE RIGHT COMMON FEMORAL ARTERY. INTRAOPERATIVE ARTERIOGRAM."

  Patient problems: Blood Loss; Diminished Pulse Pressure; No Code Available; Numbness; Pain; Weakness

  MAUDE report 9875504 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT AN ANGIO-SEAL DEVICE WAS USED AFTER THE INITIAL PROCEDURE. ULTRASOUND (US) GUIDANCE OF THE RIGHT FEMORAL ARTERY (RFA) USING A TELEFLEX VSI MICRO-ACCESS KIT THEN A 5FR TERUMO PINNACLE 10CM SHEATH. A COMMON FEMORAL ARTERY (CFA) ANGIOGRAM OF ACCESS SITE WAS PERFORMED AND THEN THEY SWITCHED FOR A 7FR DESTINATION 45CM LENGTH SHEATH TO GO UP AND OVER FOR LEFT COMMON FEMORAL ARTERY (LCFA) PLAIN OLD BALLOON ANGIOPLASTY (POBA) INTERVENTION. SEVEN THOUSAND UNITS OF HEPARIN WAS GIVEN AT THE BEGINNING OF THE INTERVENTION AND FIFTY UNITS OF PROTAMINE WAS GIVEN AT THE END OF THE CASE TO REVERSE THE HEPARIN. THE DESTINATION SHEATH WAS PULLED BACK OVER THE .035 WIRE AND THEN THE ANGIO-SEAL SHEATH WAS INSERTED OVER THE WIRE (OTW). THE ANGIO-SEAL DILATOR AND 180 CM .035 WIRE WERE REMOVED. THE ANGIO-SEAL DEVICE INSERTED AND CLICKED TOGETHER AND BACK WITH SHEATH WHEN PULLING BACK AND COMPACTING WITH THE COMPACTION TUBE THERE WAS NO OOZING OR BLEEDING. WHEN THEY PULLED THE COMPACTION TUBE BACK, THEY GOT ARTERIAL TYPE FLOW, THEY COMPACTED AGAIN AND WHEN THEY PULLED BACK THERE STILL WAS ARTERIAL TYPE FLOW. MANUAL PRESSURE WAS HELD FOR FIVE MINUTES PER SHEATH SIZE; A TOTAL

  Patient problems: Blood Loss

  MAUDE report 9829150 ↗
• InjuryMar 10, 2020Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT THE INVOLVING ANGIO-SEAL DEVICE WAS USED. AN ULTRASOUND GUIDANCE WAS USED FOR AT A LEFT COMMON FEMORAL ARTERY ACCESS WITH A 18G NEEDLE AND .035 WIRE 4F BOSTON SUPERSHEATH. THESE WERE INSERTED AND A LEFT COMMON FEMORAL ARTERY (LCFA) ANGIO IMAGING WAS TAKEN UPSIZED FOR A 6F TERUMO PINNACLE. THERE WAS NO DISEASE WITHIN 5MM OF THE ACCESS SITE. THE ACCESS LOCATION WAS AN IDEAL SPOT FOR A LEFT ILIAC INTERVENTION BALLOON AND STEIN. THE SHEATH WAS EXCHANGED FOR A 7F 45CM DESTINATION TO GO UP AND OVER TO THE RIGHT SIDE FOR THE RIGHT ILIAC INTERVENTION. THE DESTINATION DEVICE WAS PULLED BACK OVER THE .035 WIRE, THE ANGIO-SEAL SHEATH WAS INSERTED OVER THE ANGIO-SEAL DILATOR AND 180CM OF THE .035 WIRE WAS REMOVED. THE ANGIO-SEAL DEVICE WAS INSERTED AND WAS CLICKED TOGETHER AND BACK WITH THE SHEATH, WHEN PULLING BACK THE DEVICE AND COMPACTING WITH THE COMPACTION TUBE THERE WAS NO OOZING OR BLEEDING. WHEN THE COMPACTION TUBE WAS PULLED BACK, THEY GOT AN ARTERIAL FLOW. SO, THEY COMPACTED AGAIN AND WHEN THEY PULLED BACK AGAIN THERE WAS STILL AN ARTERIAL FLOW. ULTIMATELY, THEY HAD TO HOLD MANUAL PRESSURE FOR 5 MINUTES PER SHEATH SIZE SO TOTAL OF 35 MINUTES. THE PATIE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9810737 ↗
• InjuryFeb 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT A FEMALE PATIENT ENDED UP WITH A RETRO-PERITONEAL BLEED WITH A 6F ANGIO-SEAL DEVICE. THE BLEED DEVELOPED LATER AFTER THE PROCEDURE. THE PHYSICIAN CLAIMS THAT ACCESS SITE WAS NOT ABOVE INGUINAL LIGAMENT, AND AT THE COMMON FEMORAL ARTERY (CFA). IT IS UNKNOWN WHAT THE PATIENT'S HEPARIN DOSE WAS. THE PHYSICIAN USED ULTRA-SOUND TO GAIN ACCESS AND CLAIMS THAT ACCESS WAS NORMAL. THE BLOOD LOSS WAS LESS THAN 250CC. THE PATIENT CONDITION WAS REPORTED TO BE DOING BETTER. THE PROCEDURE OUTCOME WAS OTHERWISE GOOD. ADDITIONAL INFORMATION WAS RECEIVED ON 15JAN2020. THE PROCEDURE WAS A MESENTERIC INTERVENTION. IT WAS A BALLOON OR STENT PROCEDURE USING A 6FR. PROCEDURAL SHEATH. A PRE DEPLOYMENT ANGIOGRAM WAS PERFORMED. HEMOSTASIS WAS ACHIEVED AT THE TIME OF DEPLOYMENT OF THE ANGIO-SEAL DEVICE. THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 17JAN2020. MANUAL PRESSURE WAS MAINTAINED TO STOP THE BLEED.

  Patient problems: Blood Loss

  MAUDE report 9695528 ↗
• MalfunctionJan 7, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THERE WAS A LARGE SPLIT IN THE DISTAL END OF THE ANGIO-SEAL SHAFT JUST PROXIMAL TO THE BYPASS TUBE. THE ANGIO-SEAL WAS NOT ABLE TO BE ADVANCED INTO AND THROUGH THE BYPASS TUBE SO IT WAS NOT ABLE TO BE DEPLOYED. ANOTHER ANGIO-SEAL WAS THEN PULLED AND SUCCESSFULLY DEPLOYED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT IS DOING GOOD IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED 13DECEMBER2019: THE PROCEDURES PERFORMED WAS AN EMBOLIZATION PROCEDURE USING A 6FR SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9559111 ↗
• MalfunctionJan 6, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT UPON ANGIO-SEAL INSERTION INTO THE PATIENTS GROIN, THE PLASTIC SEEMED TO KINK AND TEAR. SURGICAL OR MEDICAL INTERVENTION WAS NOT REQUIRED TO COMPLETE THE CASE. ADDITIONAL INFORMATION WAS RECEIVED 11DECEMBER2019: THE PROCEDURE PERFORMED WAS A ATHERECTOMY ARTERIOGRAM USING A 6 FR SHEATH. THE DILATOR SEEMED TO BE KINKED. THE PROCEDURE WAS NOT COMPLETED WITH THAT DEVICE, THE DEVICE WAS NOT DEPLOYED DUE TO INSPECTION OF THE KINKED PLASTIC (DILATOR). THEY OPENED ANOTHER ANGIO-SEAL DEVICE. ADDITIONAL INFORMATION WAS RECEIVED 12DECEMBER2019: THERE WAS NO HARM TO THE PATIENT AND THEY LEFT FACILITY IN STABLE CONDITION. THE PROCEDURE WAS A ARTERIOGRAM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9553030 ↗
• InjuryNov 21, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT AFTER INSERTING THE ANGIO-SEAL BYPASS TUBE INTO THE ANGIO-SEAL DELIVERY SHEATH VALVE THE PHYSICIAN TRIED TO ADVANCE THE ANGIO-SEAL DEVICE, HOWEVER, THE COLLAGEN PORTION WOULD NOT ADVANCE PAST THE VALVE. THE ANGIO-SEAL SHEATH WAS REMOVED AND THEN THEY HELD MANUAL PRESSURE TO ACHIEVE HEMOSTASIS OF THE COMMON FEMORAL ARTERY. THE PATIENT CONDITION WAS GOOD. THE PROCEDURE OUTCOME WAS A SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED ON 30OCT2019. THE PROCEDURE PERFORMED PRIOR TO THE USE OF THE ANGIO-SEAL DEVICE WAS A CHEMO EMBOLIZATION. THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9356966 ↗
• InjuryNov 21, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT WHEN THEY WERE INSERTING THE COLLAGEN AND THE BYPASS TUBE, THEY COULD NOT GET THE DILATOR TO "CLICK" IN PLACE. THE DEVICE WAS NOT USED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PROCEDURE WAS A SUCCESSFUL LEG CASE (PERIPHERAL ARTERIAL DISEASE). THE DEVICE WAS NEVER IN THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 30OCT2019. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. A 6FR PROCEDURAL SHEATH WAS USED. HEMOSTASIS WAS COMPLETED WITH MANUAL COMPRESSION. THERE WAS NO BLOOD LOSS GREATER THAN 250 CC. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Blood Loss

  MAUDE report 9356965 ↗
• MalfunctionOct 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT WHEN THE ANGIO-SEAL STS PLUS DEVICE WAS PULLED BACK ONCE FOOT PLATE WAS SET THE GREEN TAMPER WOULD NOT ADVANCE INITIALLY, HOWEVER IT THEN EVENTUALLY DID WITH GREAT DIFFICULTY. FULL TENSION WAS KEPT ON THE SHEATH PORTION AND THE PLUG HUB EVENTUALLY SNAPPED. BLOOD LOSS WAS LESS THAN 250CC. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: Blood Loss

  MAUDE report 9224015 ↗
• MalfunctionOct 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT WHEN THE ANGIO-SEAL STS PLUS DEVICE WAS PULLED BACK ONCE FOOT PLATE WAS SET THE GREEN TAMPER WOULD NOT ADVANCE INITIALLY, HOWEVER IT THEN EVENTUALLY DID WITH GREAT DIFFICULTY. FULL TENSION WAS KEPT ON THE SHEATH PORTION AND THE PLUG HUB EVENTUALLY SNAPPED.

  Patient problems: No Information

  MAUDE report 9224012 ↗
• MalfunctionOct 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT WHEN THE ANGIO-SEAL STS PLUS DEVICE WAS PULLED BACK ONCE FOOT PLATE WAS SET THE GREEN TAMPER WOULD NOT ADVANCE INITIALLY, HOWEVER IT THEN EVENTUALLY DID WITH GREAT DIFFICULTY. FULL TENSION WAS KEPT ON THE SHEATH PORTION AND THE PLUG HUB EVENTUALLY SNAPPED.

  Patient problems: No Information

  MAUDE report 9224008 ↗
• MalfunctionOct 22, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE INTRODUCER SHEATH AND ARTERIOTOMY LOCATOR WAS PLACED IN THE PATIENT OVER THE WIRE. THE WIRE AND ARTERIOTOMY LOCATOR CAME OUT, THE DEVICE WITH THE BYPASS TUBE WAS INITIALLY INSERTED IN THE SHEATH; HOWEVER, IT DID NOT ADVANCE. THE PATIENT WAS IN STABLE CONDITION AND THE PROCEDURE WAS SUCCESSFUL USING A SECOND DEVICE. ADDITIONAL INFORMATION WAS RECEIVED ON 26SEP2019. THE PROCEDURE WAS A RIGHT EXTERNAL ILIAC STENT PLACEMENT VIA LEFT COMMON FEMORAL ARTERY (CFA) ACCESS USING A 5FR 45 CM SHEATH. A LEFT COMMON FEMORAL ARTERY ANGIOGRAM WAS PERFORMED PRIOR TO CLOSURE DEPLOYMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9217839 ↗
• InjurySep 25, 2019Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL DEVICE DID NOT DEPLOY CORRECTLY AND THE WHOLE SYSTEM CAME OUT WHEN TRYING TO SEAL. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED 05 SEPTEMBER 2019: THE PROCEDURE WAS AN AORTOGRAM WITH LLE ANGIO (RIGHT GROIN ACCESS) WITH A 6FR PROCEDURAL SHEATH. THERE WAS NO DIFFICULTIES WITH ARTERIAL ACCESS, IT WAS A CLEAN FEMORAL ARTERY. THERE WAS NOT A PRE-DEPLOYMENT ANGIOGRAM PERFORMED; AN ULTRASOUND WAS USED WITH ACCESS AND ABOVE AND BELOW ACCESS POINT EXAMINED. WHEN THE ANGIO-SEAL SHEATH WAS INSERTED, AND BLOOD FLOW WAS IDENTIFIED, THE INNER DILATOR WAS REMOVED AND IMPLANT DEVICE WAS INSERTED. INSERTION AND PULL BACK ON DEPLOYMENT WAS AS NORMAL, BUT WHEN THEY PULLED EVERYTHING OUT TO EXPOSE THE STITCH TO TAMP DOWN, THE WHOLE DEVICE CAME OUT. THE INNER ARTERIAL DISK WAS SEEN PEEKING OUT OF THE CATHETER. PRESSURE WAS HELD FOR 5-10 MINUTES WITH GOOD HEMOSTASIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9119263 ↗