Flexor G44154Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00827002441545), received between Apr 17, 2015 and May 12, 2026 — classified as 1 death, 27 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Material Separation” (30 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Nov 12, 2021Terminated

   Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa

   Z-0387-2022 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Leak/Splash

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A FLEXOR ANSEL GUIDING SHEATH LEAKED FROM THE VALVE. AFTER THE SHEATH WAS INITIALLY INSERTED INTO THE PATIENT, THE USER REMOVED THE DILATOR, AT WHICH POINT THE VALVE LEAKED. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS CONTINUED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25147283 ↗
• MalfunctionSep 17, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED 18SEP2025. CONTRALATERAL ACCESS WAS OBTAINED IN THE FEMORAL ARTERY FOR AN UP-AND-OVER APPROACH TO TARGET THE EXTERNAL ILIAC ARTERY. THE ACCESS SITE WAS SCARRED, AND THE ANATOMY WAS MODERATELY CALCIFIED. THE BIFURCATION WAS NOT STEEP; HOWEVER, A COVERED STENT GRAFT WAS PRESENT IN ONE OF THE ILIAC ARTERIES. ANOTHER MANUFACTURER¿S 0.035-INCH WIRE, ANOTHER MANUFACTURER¿S ORBITAL ATHERECTOMY DEVICE, AND A ¿SERIES¿ OF 014 BALLOONS WERE USED THROUGH THE SHEATHS DURING THE PROCEDURE. RESISTANCE WAS REPORTEDLY NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF OTHER DEVICES THROUGH THE SHEATHS; HOWEVER, RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE SHEATHS FROM THE PATIENT, AT WHICH POINT THE SHEATHS UNRAVELED AND SEPARATED AT THE AORTIC BIFURCATION. PER THE REPORTER, THE USER COULDN¿T REINSERT THE DILATORS PRIOR TO SHEATH REMOVAL; THEREFORE, ONLY THE 0.035-INCH WIRE WAS IN THE LUMEN WHEN THE SHEATHS UNRAVELED AND SEPARATED. THE SHEATHS WERE REMOVED FROM THE PATIENT ENDOVASCULARLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23077120 ↗
• InjurySep 11, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED 19JAN2026. THE INTENDED PROCEDURE REPORTEDLY INVOLVED DILATION AND STENT PLACEMENT WITHIN THE FEMORAL ARTERY, VIA CONTRALATERAL ACCESS IN THE LEFT FEMORAL ARTERY. IT IS UNKNOWN IF THE ACCESS SITE WAS SCARRED OR IF THE ANATOMY WAS STENOSED, TORTUOUS, OR CALCIFIED. ANOTHER MANUFACTURER¿S WIRE GUIDE WAS USED WITH THE SHEATH. AN UNSPECIFIED 5MM X 200MM BALLOON WAS ADVANCED THROUGH THE SHEATH AND USED TO DILATE THE EXTERNAL ILIAC STENT AND THE LEFT COMMON FEMORAL ARTERY. RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR REMOVAL OF ANY DEVICE THROUGH THE SHEATH. AS THE USER ATTEMPTED TO REMOVE THE SHEATH AFTER BALLOON DILATION, WITH THE WIRE AND BALLOON CATHETER IN THE SHEATH LUMEN, RESISTANCE WAS ENCOUNTERED, AND THE SHEATH SEPARATED INTO TWO SECTIONS. THE DILATOR WAS NOT REINSERTED PRIOR TO SHEATH REMOVAL. THE PROXIMAL SECTION OF THE SHEATH WAS REMOVED FROM THE PATIENT; HOWEVER, THE DISTAL SECTION WAS STUCK IN THE FEMORAL ARTERY. THE PROCEDURE WAS REPORTEDLY ¿SPLIT¿, AND THE DISTAL FRAGMENT WAS REMOVED DURING A SURGICAL CUT-DOWN. PER THE REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23025948 ↗
• MalfunctionNov 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING A PROCEDURE INVOLVING TREATMENT OF THE SUPERFICIAL FEMORAL ARTERY (SFA), A FLEXOR ANSEL GUIDING SHEATH'S HUB LEAKED AFTER/WHILE ANOTHER MANUFACTURER'S WIRE WAS INSERTED. A COOK STENT WAS ALSO USED THROUGH THE SHEATH. THE SHEATH HUB DID NOT LEAK WHILE BEING FLUSHED PRIOR TO USE. PER THE REPORTER, BLOOD WAS "BACKING UP" OUT OF THE PROXIMAL END OF THE SHEATH. RESISTANCE WAS NOT FELT DURING INSERTION OR REMOVAL OF ANY DEVICE THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SHEATH WITHOUT ANY OTHER INTERVENTION. PER THE USER, "THE PATIENT HAD NOTHING TO DO WITH THE PROBLEM". A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799749 ↗
• MalfunctionSep 4, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20137102 ↗
• MalfunctionApr 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, UPON COMPLETION OF AN ANGIOPLASTY PROCEDURE, THE HUB SEPARATED FROM A FLEXOR ANSEL GUIDING SHEATH UPON REMOVAL OF THE DEVICE FROM THE PATIENT. ACCESS WAS OBTAINED IN THE GROIN TO TARGET THE SUPERFICIAL FEMORAL ARTERY. THE ANATOMY WAS NOT TORTUOUS, SCARRED, OR CALCIFIED, AND RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF THE DEVICE. ANOTHER MANUFACTURER'S BALLOONS WERE USED THROUGH THE SHEATH, AS WELL AS ANOTHER MANUFACTURER'S WIRE GUIDE. UPON COMPLETION OF THE PROCEDURE, THE SHEATH WAS REMOVED OVER THE WIRE GUIDE, WITHOUT REINSERTING THE DILATOR, AT WHICH POINT THE HUB SEPARATED. A CLAMP WAS THEN USED TO PULL THE DEVICE FROM THE PATIENT, AND IT WAS REPLACED WITH AN UNSPECIFIED SHORT SHEATH. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19015298 ↗
• MalfunctionDec 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED 14DEC2023. THE PROCEDURE WAS A LEG ANGIOGRAM. AN UNSPECIFIED BENTSON WIRE GUIDE, ANOTHER MANUFACTURER'S WIRE GUIDE, AND ANOTHER MANUFACTURER'S BALLOON WERE USED DURING THE PROCEDURE. DURING ADVANCEMENT OF DEVICES THROUGH THE SHEATH, THE VALVE WAS TIGHT, AND "A BIT TOUGHER TO PUSH THROUGH THAN OTHERS". A WIRE WAS IN THE SHEATH AT THE TIME THE LEAK WAS NOTED IN THE SHEATH, AND THE WIRE WAS REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT DID NOT REQUIRE ANY TREATMENT FOR BLOOD LOSS. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18265465 ↗
• MalfunctionNov 21, 2023Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18180855 ↗
• MalfunctionSep 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17829458 ↗
• MalfunctionSep 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN ANGIOGRAM OF THE LEG, THE HUB SEPARATED FROM A FLEXOR ANSEL GUIDING SHEATH. THE PATIENT HAD A HISTORY OF DIFFICULT GROIN ACCESS, DUE TO SCARRING, AND A PREVIOUS BYPASS PROCEDURE. ACCESS WAS OBTAINED IN THE SCARRED GROIN. THE ANATOMY WAS TORTUOUS, CALCIFIED, AND VERY SCARRED. RESISTANCE WAS ENCOUNTERED UPON BOTH INSERTION AND REMOVAL OF THE SHEATH. AN UNKNOWN WIRE AND ANOTHER MANUFACTURER'S ATHERECTOMY DEVICE WERE IN THE SHEATH LUMEN AT THE TIME OF HUB SEPARATION. THE DILATOR WAS NOT IN PLACE AT THE TIME OF SEPARATION, AND THE SHEATH HUB WAS NOT USED TO PULL THE DEVICE FROM THE PATIENT. BECAUSE PART OF THE SHEATH WAS OUTSIDE OF THE PATIENT, THE SHEATH SHAFT WAS REMOVED MANUALLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17755959 ↗
• MalfunctionJul 26, 2023Material Separation; Unraveled Material; Detachment of Device or Device Component; Material Separation; Unraveled Material; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17399228 ↗
• InjuryJul 26, 2023Break; Break

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Foreign Body In Patient; Unspecified Heart Problem

  MAUDE report 17398859 ↗
• MalfunctionApr 7, 2023Peeled/Delaminated; Peeled/Delaminated

  AS ORIGINALLY REPORTED, DURING AN ANGIOGRAM OF THE LEG, A COOK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON BECAME STUCK IN A FLEXOR ANSEL GUIDING SHEATH. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY AND A CONTRALATERAL APPROACH WAS USED TO TARGET A 60-70% OCCLUDED LESION IN THE LEFT MIDDLE SUPERFICIAL FEMORAL ARTERY. DEVICES WERE ADVANCED OVER ANOTHER MANUFACTURER'S 0.035-INCH WIRE GUIDE. THE ANATOMY WAS REPORTEDLY TORTUOUS, AND SOME RESISTANCE WAS NOTED UPON ADVANCEMENT OF BOTH THE SHEATH AND BALLOON; HOWEVER, THE DEVICES REACHED THE TARGET LOCATION. THE BALLOON WAS INFLATED TO TEN ATMOSPHERES WITH AN INFLATION DEVICE TWO TIMES, FOR APPROXIMATELY THREE TO FIVE SECONDS EACH TIME, AND WORKED FINE. THE BALLOON WAS ALLOWED TO RETURN TO AMBIENT PRESSURE. UPON REMOVAL OF THE BALLOON, WHILE MAINTAINING NEGATIVE PRESSURE, IT BECAME STUCK IN THE SHEATH AND ON THE WIRE. A COUNTER-CLOCKWISE ROTATION OF THE BALLOON WAS NOT CONDUCTED UPON ATTEMPTED WITHDRAWAL OF THE BALLOON CATHETER. RESISTANCE WAS ENCOUNTERED, BUT THE PHYSICIAN REPORTEDLY PULLED A "LITTLE MORE" AND THE WIRE, SHEATH, AND BALLOON WERE REMOVED FROM THE PATIENT, LOSING ACCESS. TWO PARTS OF THE BALLOON, THE PORT AND PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702910 ↗
• InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED 19APR2023. THE PROCEDURE WAS ANGIOPLASTY AND THE OTHER MANUFACTURER'S STENT WAS INTENDED TO BE PLACED IN THE RIGHT HUMERAL ARTERY. THE DILATOR WAS EASY TO ADVANCE THROUGH THE SHEATH. THE ORIGINAL INTENDED PROCEDURE WAS NOT COMPLETED. NO PART OF THE COOK SHEATH WAS LEFT IN THE PATIENT. THERE WERE REPORTEDLY NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16539716 ↗
• MalfunctionOct 17, 2022Break; Material Separation; Detachment of Device or Device Component; Break; Material Separation; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614242 ↗
• MalfunctionOct 11, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED, PRIOR TO PATIENT CONTACT FOR AN UNSPECIFIED PROCEDURE, A HAIR WAS NOTICED IN THE PACKAGING OF A FLEXOR ANSEL GUIDING SHEATH. THE DEVICE WAS NOT USED FOR THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15581323 ↗
• MalfunctionJul 29, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING AN "ANGIO" OF THE RIGHT LEG, THE TIP OF A FLEXOR ANSEL GUIDING SHEATH TORE. RESISTANCE WAS REPORTEDLY ENCOUNTERED UPON ADVANCEMENT OF THE DEVICE OVER AN UNSPECIFIED 0.035 STIFF ANGLED GLIDEWIRE, AND THE DEVICE REPORTEDLY BENT. UPON REMOVAL OF THE DEVICE, IT WAS NOTED THAT THE TIP WAS TORN. THE ANATOMY WAS MILDLY CALCIFIED. ANOTHER SHEATH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT ISSUE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15128397 ↗
• InjuryJun 3, 2022Break; Break

  AS REPORTED, DURING AN ANGIOPLASTY PROCEDURE, A FLEXOR ANSEL GUIDING SHEATH SEPARATED IN THE LEFT COMMON AND EXTERNAL ILIAC ARTERIES UPON WITHDRAWAL OF THE DEVICE. GENERAL ANESTHESIA WAS ADMINISTERED AND A LEFT FEMORAL APPROACH WAS USED TO REMOVE THE FOREIGN BODY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14593658 ↗
• InjuryMay 7, 2022Break; Unraveled Material; Break; Unraveled Material

  AS REPORTED, DURING A SELECTIVE ANGIOGRAM OF THE LEFT LEG, A FLEXOR ANSEL GUIDING SHEATH UNRAVELED AND SEPARATED. ACCESS WAS OBTAINED IN A UNIQUELY CALCIFIED GROIN/RIGHT FEMORAL ARTERY. THE LEFT COMMON AND EXTERNAL ILIAC ARTERIES WERE CALCIFIED, THE VESSELS WERE VERY TORTUOUS, AND THERE WAS A 90% OCCLUDED LESION IN THE MID-LEFT SUPERFICIAL FEMORAL ARTERY. THE COMPLAINT DEVICE WAS ADVANCED INTO THE LEFT COMMON ILIAC ARTERY, AT WHICH POINT IT BECAME STUCK WITHIN CALCIFICATION AND WAS UNABLE TO BE ADVANCED OR PULLED BACK. AN UNSPECIFIED "IMA" CATHETER WAS THEN PLACED THROUGH THE SHEATH AND THE CATHETER AND SHEATH WERE PULLED BACK TOGETHER OVER A WIRE GUIDE. THE SHEATH SUBSEQUENTLY UNRAVELED AND THE SHEATH TIP BECAME STUCK AT THE RIGHT FEMORAL ACCESS SITE. A VASCULAR SURGEON WAS CONSULTED, AND A SURGICAL CUT-DOWN PROCEDURE WAS PERFORMED TO REMOVE THE TIP OF THE SHEATH. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14322376 ↗
• MalfunctionApr 7, 2022Break; Break

  AS REPORTED, A FLEXOR ANSEL GUIDING SHEATH SEPARATED DURING AN UNSPECIFIED PROCEDURE. ADDITIONAL EVENT AND PATIENT OUTCOME INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14044412 ↗
• MalfunctionMar 29, 2022Unraveled Material; Unraveled Material

  AS REPORTED, UPON SUCCESSFUL COMPLETION OF A PERIPHERAL CROSSOVER INTERVENTION, A FLEXOR ANSEL GUIDING SHEATH UNRAVELED UPON REMOVAL OF THE DEVICE. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY, AND A CONTRALATERAL APPROACH WAS USED TO TARGET THE EXTERNAL ILIAC. MILD CALCIFICATION WAS NOTED. IT IS UNKNOWN IF RESISTANCE WAS ENCOUNTERED UPON INSERTION OR REMOVAL OF THE SHEATH. UPON REMOVAL, THE SHEATH BEGAN TO UNRAVEL MID-SHAFT. THE DILATOR WAS NOT REINSERTED PRIOR TO REMOVAL, AND WAS NOT IN PLACE AT THE TIME OF UNRAVELING. THE SHEATH, WHICH DID NOT FULLY SEPARATE, WAS ABLE TO BE MANUALLY REMOVED FROM THE PATIENT IN ONE PIECE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13940033 ↗
• MalfunctionFeb 22, 2022Break; Peeled/Delaminated; Unraveled Material; Break; Peeled/Delaminated; Unraveled Material

  UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE INNER COIL WAS NOTED TO BE UNRAVELED AND EXITING THE SHEATH'S HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13578946 ↗
• InjuryNov 10, 2021Stretched; Unraveled Material; Detachment of Device or Device Component; Stretched; Unraveled Material; Detachment of Device or Device Component

  AS REPORTED, DURING AN AORTOGRAM VIA CONTRALATERAL ACCESS, PERFORMED PRIOR TO PLACEMENT OF A STENT WITHIN THE SUPERFICIAL FEMORAL ARTERY, A FLEXOR ANSEL GUIDING SHEATH STRETCHED AND UNRAVELED AT THE TIP UPON REMOVAL OF THE DEVICE. THE DILATOR WAS NOT REINSERTED PRIOR TO REMOVAL OF THE SHEATH. THE PATIENT WAS TRANSFERRED TO A HOSPITAL FOR SURGICAL REMOVAL OF THE DEVICE. THE PATIENT WAS REPORTEDLY DOING WELL THE FOLLOWING MORNING. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE HUB WAS ALSO NOTED TO BE SEPARATED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12788634 ↗
• MalfunctionSep 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12522153 ↗
• MalfunctionSep 23, 2021Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12518339 ↗