Angio-Seal™ VIP (REF 610130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 05414734054591), received between Apr 20, 2017 and Nov 30, 2017 — classified as 41 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (16 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 80 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2017Material Fragmentation; Material Fragmentation

  THE USER FACILITY REPORTED THE DEVICE SHEATH FELL APART UPON APPLICATION. THERE WAS NO BLOOD LOSS. THE PROCEDURE WAS COMPLETED, AND THERE WERE NO OTHER DEVICES OR EQUIPMENT BEING USED WITH THE REPORTED DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7072057 ↗
• MalfunctionNov 30, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE ANGIOSEAL ACCESS SHEATH CAME APART. IT WAS REPORTED THAT THE PROCEDURE OUTCOME WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7071150 ↗
• MalfunctionNov 29, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE ANGIOSEAL ACCESS SHEATH CAME APART. ADDITIONAL INFORMATION WAS RECEIVED ON 11/8/2017. THE SHEATH OF THE ANGIOSEAL CAME APART.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7068335 ↗
• MalfunctionNov 20, 2017Bent; Bent

  THE USER FACILITY REPORTED THE TIP OF THE INVOLVED ANGIO-SEAL DEVICE WAS BENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER: THE ANGIO-SEAL WAS BENT COMING OUT OF THE PACKAGE. THE LAB DID NOT USE THE DEVICE ON PATIENT, THEY DECIDED TO USE ANOTHER. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2017. HEMOSTASIS WAS ACHIEVED BY THE SECOND DEVICE USED. THE PATIENT PROCEDURE WAS SUCCESSFUL, AND HEMOSTASIS WAS ACHIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7046522 ↗
• InjuryNov 16, 2017Kinked; Kinked

  THE USER FACILITY REPORTED THAT THE PHYSICIAN ATTEMPTED TO DEPLOY THE FOOTPLATE AND THE DEVICE WAS KINKED AND WOULD NOT ADVANCE THROUGH THE ARTERIOTOMY LOCATOR. THE PHYSICIAN THEN DID MANUAL PRESSURE. NOTHING WAS DEPLOYED IN THE PATIENT WITH REGARD TO THE ANGIOSEAL DEVICE. THE PATIENT WAS REPORTED TO BE FINE. THE PROCEDURE OUTCOME WAS REPORTED TO BE FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7037110 ↗
• MalfunctionNov 10, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE USER FACILITY REPORTED NO/INADEQUATE BLOOD RETURN WHEN USING THE ANGIO-SEAL VIP DEVICE DURING AN INTERVENTIONAL CATHETERIZATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: CASE WAS COMPLETE EXCEPT FOR CLOSURE DEVICE. ONCE THE ARTERIOTOMY LOCATOR WAS INSERTED INTO THE PATIENT, THERE WAS NO VISIBLE BLOOD FLASH. SO THE DEVICE WAS PULLED OUT AND ANOTHER ANGIO-SEAL WAS OPENED. THE SECOND ANGIO-SEAL WAS SUCCESSFUL. THE PROCEDURE OUTCOME WAS REPORTED TO BE SUCCESSFUL. ADDITIONAL INFORMATION WAS REPORTED ON 10/17/2017: BLOOD LOSS WAS REPORTED TO BE MINIMAL. THE PATIENT WAS REPORTED TO BE FINE AND STABLE. NO OTHER DEVICES WERE USED.

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

  MAUDE report 7016889 ↗
• InjuryOct 25, 2017Positioning Failure; Positioning Failure

  THE USER FACILITY REPORTED PULL OUT WITH THE INVOLVED ANGIO-SEAL DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE DOCTOR DID EVERYTHING RIGHT AS FAR AS THE STEPS GO TO LOAD THE DEVICE.; UPON PULLING BACK, HE MET NO RESISTANCE AGAINST THE VESSEL WALL; AFTER HE PULLED BACK, THERE WAS NO ANCHOR, COLLAGEN, SUTURE, OR TAMPER; THEY HELD MANUAL PRESSURE, AND THERE WERE NO COMPLICATIONS; THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION; AND THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6976286 ↗
• InjuryOct 18, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  TERUMO MEDICAL RECEIVED MW5072004 ON (B)(6) 2017 THAT REPORTED THE FOLLOWING INFORMATION: "NEURO INTERVENTION VIA RIGHT COMMON FEMORAL ARTERY. ANGIOSEAL DEPLOYMENT FAILURE. COLLAGEN PLUG MAL-POSITIONED. VASCULAR SURGERY CONSULTED AND PATIENT TAKEN TO OPERATING ROOM FOR REMOVAL OF ANGIOSEAL, REPAIR OF RIGHT COMMON FEMORAL ARTERY." ADDITIONAL INFORMATION WAS RECEIVED 10/2/2017: PATIENT DEMOGRAPHICS: (B)(6) YEAR OLD FEMALE. MINIMAL BLEEDING EXPERIENCED (APPROXIMATELY 30ML). PATIENT RECOVERED POST-SURGERY.

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

  MAUDE report 6958749 ↗
• InjuryOct 17, 2017Positioning Failure; Positioning Failure

  THE USER FACILITY REPORTED ANGIO-SEAL VIP WAS INSERTED INTO A 6FR ACCESS SITE. WHEN PHYSICIAN CLICKED DEVICE BACK AND PULLED OUT OF WOUND TRACK, NO SUTURE WAS VISIBLE. ANCHOR WAS NOT DEPLOYED WHEN PULLED BACK TO CLICK AND THEREFORE NO SUTURE OR PUSH ROD WERE EXPOSED. MANUAL PRESSURE WAS APPLIED. IT WAS REPORTED THAT THE PATIENT WAS STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 9/28/2017: NO MAJOR BLOOD LOSS.

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

  MAUDE report 6954357 ↗
• InjuryOct 16, 2017Positioning Failure; Activation, Positioning or Separation Problem; Positioning Failure; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT UPON DEPLOYMENT OF ANGIO-SEAL INTO FEMORAL ARTERY, THE ANCHOR DID NOT SET INSIDE THE ARTERY AND ENTIRE SYSTEM PULLED OUT WHILE PHYSICIAN WAS ATTEMPTING TO TAMP COLLAGEN DOWN. IT WAS REPORTED THAT THE PATIENT OCCURRED A HEMATOMA AND THAT ADDITIONAL MANUAL PRESSURE WAS REQUIRED. IT WAS REPORTED THAT THE PATIENT CONDITION WAS STABLE.

  Patient problems: Hematoma; No Consequences Or Impact To Patient

  MAUDE report 6952764 ↗
• InjuryOct 5, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE DEVICE WAS DELIVERED PER IFU AND FAILED TO SEAL. MANUAL PRESSURE WAS HELD FOLLOWING FAILURE AND HEMOSTASIS WAS ACHIEVED. IT WAS REPORTED THAT THE PATIENT CONDITION WAS STABLE. IT WAS REPORTED THAT THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 9/11/2017: IT WAS REPORTED THAT THE BLOOD LOSS WAS LESS THAN 250CC.

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

  MAUDE report 6915010 ↗
• MalfunctionOct 2, 2017Bent; Bent

  THE USER FACILITY REPORTED THAT THE CATHETER ON THE DEVICE WAS BENT. IT WAS REPORTED THAT THIS WAS NOT USED ON PATIENT. STAFF NOTICED IT WAS BENT AND OPENED ANOTHER DEVICE. IT WAS REPORTED THAT THE PATIENT CONDITION WAS NOT AFFECTED AND THE PROCEDURE OUTCOME WAS GOOD. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6906746 ↗
• MalfunctionSep 28, 2017Difficult To Position; Difficult To Position

  THE USER FACILITY REPORTED THAT THE GREEN TAMPER TUBE WOULD NOT ADVANCE INTO THE TRACT. IT WAS REPORTED THAT THE ESTIMATED BLOOD LOSS WAS LESS THAN 250 CC. IT WAS REPORTED THAT THE PATIENT CONDITION WAS STABLE AND BASELINE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. A 6FR PINNACLE STANDARD IK WAS USED WITH THE PRODUCT.

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

  MAUDE report 6900372 ↗
• InjurySep 26, 2017Positioning Failure; Occlusion Within Device

  THE USER FACILITY REPORTED A VESSEL OCCLUSION. ADDITIONAL INFORMATION WAS RECEIVED ON 9/6/2017. THE ANGIOSEAL DEPLOYMENT FAILED AND MANUAL PRESSURE WAS HELD. ON (B)(6) 2017 THE DOCTOR STUCK OPPOSITE GROIN TO DO CONTRALATERAL INTERVENTION, SAW OCCLUSIVE DISEASE IN CFA AROUND THE LEVEL OF WHERE THE ANGIO-SEAL WAS PREVIOUSLY DEPLOYED AND PROCEEDED WITH DIRECTIONAL ATHERECTOMY AND DCB TO TREAT CFA. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION. THE PROCEDURE OUTCOME WAS REPORTED TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient; Occlusion

  MAUDE report 6893877 ↗
• InjurySep 26, 2017Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED A VESSEL OCCLUSION. ANGIO-SEAL HAS RECENTLY HAD SOME ISSUES WITH ARTERIES BECOMING OBSTRUCTED AND CAUSING COLD LEGS. NOT SURE OF THE CAUSE BUT IT SEEMS THE COLLAGEN AND ANCHOR ARE WITHIN THE ARTERY AFTER LOOKING AT FILMS. ACCORDING TO ACCOUNT THEY HAVE SEEN THIS RECENTLY. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION AND TO HAVE COLD LEG. THE PROCEDURE OUTCOME WAS REPORTED TO BE GOOD, THERE WAS COLD LEG BLOCKED ARTERY. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2017. THE DOCTOR DEPLOYED THIS ANGIO-SEAL ON 2/26/2017 AND HE RE-INTERVENED ON (B)(6) 2017 THROUGH THE SAME RIGHT CFA AND NOTICED INFLAMMATION/BLOCKAGE AT THE LEVEL OF THE ORIGINAL ANGIO-SEAL DEPLOYMENT.

  Patient problems: Obstruction/Occlusion; Occlusion

  MAUDE report 6893875 ↗
• InjurySep 26, 2017Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT ANGIOSEAL HAS RECENTLY HAD SOME ISSUES WITH ARTERIES BECOMING OBSTRUCTED AND CAUSING COLD LEGS. NOT SURE OF THE CAUSE BUT IT SEEMS THE COLLAGEN AND ANCHOR ARE WITHIN THE ARTERY AFTER LOOKING AT FILMS. ADDITIONAL INFORMATION WAS RECEIVED ON 9/6/2017 UPDATE: IT WAS REPORTED THAT THE HEAVILY DISEASED LEG, CALCIUM PRESENT AT ACCESS SITE, ANTEGRADE STICK, ANGIOSEAL DEPLOYMENT WAS SUCCESSFUL. PATIENT'S LEG WAS LYSED FOR THREE DAYS FOLLOWING INTERVENTION AND WAS EVENTUALLY AMPUTATED. THE PHYSICIAN DOES NOT ATTRIBUTE THIS TO THE ANGIO-SEAL. ADDITIONAL INFORMATION WAS RECEIVED ON 9/13/2017 UPDATE: IT WAS REPORTED THAT THE ANGIOSEAL SEEMED TO DEPLOY SUCCESSFULLY BASED ON THE ANGIO PICTURES. THE REPORTED PRODUCT SIZE WAS A 6FR VIP.

  Patient problems: No Code Available; Occlusion

  MAUDE report 6893507 ↗
• InjurySep 26, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING SUBMITTED IN RESPONSE TO USER FACILITY MEDWATCH REPORT (B)(4) WAS RECEIVED FROM THE FDA ON AUGUST 28, 2017. THE EVENT DESCRIPTION STATES THE FOLLOWING: "PATIENT UNDERWENT A HEART CATHETERIZATION WITH ANGIO-SEAL VIP 6F TO RIGHT GROIN OVER ONE MONTH AGO. THE PATIENT UNDERWENT HEART CATHETERIZATION FROM A RIGHT FEMORAL APPROACH AN ANGIO SEAL CLOSURE DEVICE LESS THAN 10 DAYS AGO. THE PATIENT PRESENTED WITH SIGNS OF RIGHT GROIN INFECTION INCLUDING MULTIPLE AREAS OF ERYTHEMA AND SMALL PUSTULES. ACT ANGIOGRAM REVEALED PHLEGM ON VERSUS FLUID COLLECTIONS. UPON ENTERING THE SUBCUTANEOUS TISSUE, MULTIPLE POCKETS OF PURULENT FLUID WERE ENCOUNTERED. MULTIPLE CULTURES OF THIS FLUID WERE SENT. TOMRAMYCIN AND VANCOMYCIN ANTIBIOTICS BEADS WERE PLACED UNDER THE MUSCLE FLAP DIRECTLY ONTO THE ARTERIAL WALL AND ON TOP OF THE MUSCLE FLAP. INFECTED NECROTIC TISSUE WAS SHARPLY DEBRIDED FROM THE SUBCUTANEOUS TISSUES. THE WOUND WAS THEN IRRIGATED WITH BACITRACIN AND POLYMYXIN ANTIBIOTIC IRRIGATION.

  Patient problems: Erythema; Necrosis; Purulent Discharge; Swelling; Unspecified Infection

  MAUDE report 6893037 ↗
• MalfunctionSep 6, 2017Fracture; Fracture

  THE USER FACILITY REPORTED THAT ANGIO-SEAL PULLED APART AFTER THE FIRST CLICK. IT WAS REPORTED THAT THEY WERE STILL ABLE TO SET THE FOOTPLATE AND SUTURE DOWN COLLAGEN. IT WAS REPORTED THAT THE PATIENT CONDITION WAS NOT AFFECTED. THEY WERE AWAKE, ALERT AND ORIENTATED. IT WAS REPORTED THAT THE PROCEDURE OUTCOME WAS NOT AFFECTED AND HAD A SUCCESSFUL CLOSURE. IT WAS REPORTED THAT THE BLOOD LOSS WAS LESS THAN 250CC'S. THERE WERE NO OTHER PRODUCTS USED WITH THE REPORTED DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6846108 ↗
• MalfunctionSep 5, 2017Kinked; Kinked

  THE USER FACILITY REPORTED THAT THE ANGIO-SEAL WAS PREPPED PER IFU AND UPON ADVANCING DEVICE OVER .035" WIRE, IT WAS NOTICED THAT THERE WAS A KINK IN THE ENTRY SHEATH. IT WAS REPORTED THAT THE PATIENT CONDITION WAS STABLE. IT WAS REPORTED THAT THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 8/15/2017: THE BLOOD LOSS WAS NOT GREATER THAN 250 CC. AT THE TIME THE ANGIO-SEAL DEVICE WAS THE ONLY PRODUCT IN PLACE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6841338 ↗
• MalfunctionSep 1, 2017Kinked; Kinked

  THE USER FACILITY REPORTED THAT THE ANGIOSEAL WAS PREPPED PER IFU AND UPON ADVANCING DEVICE OVER .035" WIRE, IT WAS NOTICED THAT THERE WAS A KINK IN THE ENTRY SHEATH. IT WAS REPORTED THAT THE PATIENT CONDITION WAS STABLE. IT WAS REPORTED THAT THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 8/15/2017: THE BLOOD LOSS WAS NOT GREATER THAN 250CC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6839479 ↗
• MalfunctionSep 1, 2017Kinked; Kinked

  THE USER FACILITY REPORTED THAT THE ANGIOSEAL WAS PREPPED PER IFU AND UPON ADVANCING DEVICE OVER .035" WIRE, IT WAS NOTICED THAT THERE WAS A KINK IN THE ENTRY SHEATH. IT WAS REPORTED THAT THE PATIENT CONDITION WAS STABLE. IT WAS REPORTED THAT THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 8/15/2017: THE BLOOD LOSS WAS NOT GREATER THAN 250CC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6839473 ↗
• InjuryAug 24, 2017Positioning Failure; Positioning Failure

  THE USER FACILITY REPORTED DIFFICULTIES WITH THE INVOLVED ANGIO-SEAL DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: LEFT HEART CATH. NO TORTUOSITY OR CALCIFICATION. PERFECT LOCATION TO USE THE ANGIO-SEAL CLOSURE DEVICE. 6F SHEATH WAS IN PLACE SO THEY USE A 6F ANGIO SEAL. EVERYTHING WAS GOING WELL AND THE OPERATOR SCRUBBED AND USED THE DEVICE CORRECTLY. WHEN HE PULLED BACK TENSION ON THE DEVICE THE ENTIRE THING POPPED OUT AND THE ANCHOR WAS NOT VISIBLE, FOR IT HAD NOT DEPLOYED. PATIENT WAS REPORTED TO BE STABLE. BLOOD LOSS WAS LESS THAN 250 CC. THE PROCEDURE OUTCOME WAS SUCCESSFUL. CATHETERS, WIRES AND TERUMO PINNACLE 6FR SHEATH WAS USED. ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 4, 2017. MANUAL COMPRESSION WAS HELD.

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

  MAUDE report 6816967 ↗
• MalfunctionAug 24, 2017Detachment Of Device Component; Detachment Of Device Component

  THE USER FACILITY REPORTED THE INVOLVED ANGIO-SEAL DEVICE COMPONENT WAS OUTSIDE THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE PLUG ANCHOR THAT GOES UNDER THE SKIN WAS ALREADY OUTSIDE OF THE DEVICE; THERE WERE NO OTHER DEVICES OR EQUIPMENT BEING USED WITH THE PRODUCT; THE PROCEDURE OUTCOME WAS GOOD; AND THE PATIENT WAS REPORTED TO BE GOOD. ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 10, 2017. THEY CREATED HEMOSTASIS BY USING ANOTHER ANGIO-SEAL DEVICE. PATIENT WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6816947 ↗
• InjuryAug 23, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE USER FACILITY REPORTED THAT THEY DEPLOYED AN ANGIOSEAL AND SHUT DOWN THE FEMORAL ARTERY. IT WAS REPORTED THAT THE PHYSICIAN REPAIRED IT ENDOVASCULARLY WITH A SHORT VIABAHN STENT IN THE COMMON FEMORAL. THE PATIENT IS DOING VERY WELL AT PRESENT TIME. IT WAS REPORTED THAT THE PROCEDURE OUTCOME HAS A GOOD ULTIMATE RESULT WITH IMPROVED TIBIAL BLOOD FLOW TO ASSIST IN HEALING OF A RIGHT HEEL LESION. IT WAS REPORTED THAT THERE WAS AN INSIGNIFICANT AMOUNT OF BLOOD LOSS. ADDITIONAL INFORMATION WAS REPORTED ON 8/1/2017: THE DEVICE DEPLOYED IN A STANDARD FASHION, BUT THERE WAS IMMEDIATE BLEEDING AFTER DEPLOYMENT SUGGESTING MALFUNCTION. MANUAL PRESSURE WAS APPLIED TO OBTAIN HEMOSTASIS. WE THEN TRANSFERRED HER TO RECOVERY, BUT IMMEDIATELY NOTICED THE FOOT WAS DUSKY AND PULSELESS SO WE BROUGHT HER BACK TO THE ANGIO SUITE AND ACCESSED THE CONTRALATERAL (LEFT SIDE). WITH UP-AND-OVER TECHNIQUE AN ANGIO SHOWED COMPLETE FEMORAL ARTERY OCCLUSION. WITH DIFFICULTY WE CROSSED IT, ASPIRATED ANY LOSE THROMBUS AND THEN BALLOONED IT OVER A FILTER WIRE PRODUCING A PARTIAL RESULT. WE FELT IT WOULD REOCCLUDE DESPITE MULTIPLE PROLONGED INFLATIONS AND ELECTED TO TREAT IT WITH A SINGLE 6 MM X 50 MM VIABAHN WHIC

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

  MAUDE report 6813839 ↗
• InjuryAug 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE ANGIO SEAL DEVICE DEPLOYED NORMALLY AND A FEW DAYS LATER THE PATIENT PRESENTED WITH A LARGE THROMBUS AND GROIN PAIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: UPON ULTRASOUND, IT WAS CONFIRMED THE CFA HAD BEEN OCCLUDED. THE DOCTOR BROUGHT THE PATIENT BACK FOR AN ATHERECTOMY AND THE PATIENT IS NOW STABLE. THE PROCEDURE OUTCOME WAS REPORTED TO BE SATISFACTORY.

  Patient problems: Pain; Thrombus

  MAUDE report 6798043 ↗