Flexor G56232Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00827002562325), received between Apr 13, 2016 and May 29, 2025 — classified as 4 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Material Separation” (10 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2025. CONTRALATERAL ACCESS WAS OBTAINED IN THE RIGHT GROIN TO TARGET THE LEFT SUPERFICIAL FEMORAL ARTERY. THE ACCESS SITE WAS NOT SCARRED, AND THE BIFURCATION ANGLE WAS NORMAL; HOWEVER, ¿SOME¿ CALCIFICATION WAS NOTED WITHIN THE ANATOMY, INCLUDING AT THE BIFURCATION. A 260-CENTIMETER COOK ROADRUNNER STIFF ANGLED WIRE GUIDE WAS USED DURING THE PROCEDURE. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF ANY DEVICE THROUGH THE SHEATH; HOWEVER, ¿SOME¿ RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE SHEATH OVER A WIRE, WITH THE DILATOR IN PLACE. THE HUB WAS USED TO PULL THE SHEATH FROM THE PATIENT. AFTER THE HUB SEPARATED, THE SHEATH SHAFT WAS MANUALLY PULLED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND A CLOSURE DEVICE WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105578 ↗
• MalfunctionNov 8, 2024Unraveled Material; Unraveled Material

  ADDITIONAL INFORMATION RECEIVED 08NOV2024. THE INTENDED PROCEDURE WAS AN ANGIOGRAM WITH POSSIBLE ANGIOPLASTY/ATHERECTOMY. ACCESS WAS GAINED VIA THE RIGHT GROIN (WHICH WAS NOT SCARRED), TARGETING THE COMMON FEMORAL ARTERY. THE PATIENT'S ANATOMY WAS NOT STENOSED, TORTUOUS, OR CALCIFIED. A CONTRALATERAL APPROACH WAS USED, AND THE BIFURCATION ANGLE WAS NOT STEEP, ACUTE, OR CALCIFIED. UPON INSERTION OF THE SHEATH OVER A COMPETITOR'S 0.35" 260CM WIRE GUIDE, THE SHAFT OF THE SHEATH SEPARATED AND "LOOKED LIKE IT UNWOUND ITSELF". THE USER COULD SEE THE "FILAMENTS" THAT WIND AROUND THE DEVICE. THE SHEATH WAS NOT COMPLETELY INSERTED WHEN THE SEPARATION OCCURRED, AND THE SHEATH WAS BACKED OUT. THERE WERE NO OTHER DEVICES USED THROUGH THE SHEATH. RESISTANCE WAS NOT FELT DURING INSERTION OR REMOVAL OF THE SHEATH. THE SHEATH DID NOT SEPARATE AT THE HUB AND WAS NOT REMOVED VIA THE HUB. IT IS UNKNOWN IF THE DILATOR WAS INSERTED PRIOR TO REMOVAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER SHEATH. THERE WAS NO UNINTENDED SECTION OF THE DEVICE THAT REMAINED INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR REPORT ANY ADVERSE EFFECTS DUE TO THE EVENT.

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

  MAUDE report 20642160 ↗
• MalfunctionDec 14, 2023Material Separation; Unraveled Material; Material Separation; Unraveled Material

  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 18327568 ↗
• MalfunctionAug 7, 2023Detachment of Device or Device Component; 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 17470929 ↗
• MalfunctionJul 5, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED, THE CUSTOMER DISCOVERED A HAIR IN THE STERILE PACKAGING OF A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH. ANOTHER DEVICE WAS USED INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14914853 ↗
• InjuryJan 31, 2022Break; Unraveled Material; Break; Unraveled Material

  AS REPORTED, DURING AN ATHERECTOMY PROCEDURE INVOLVING THE RIGHT SUPERFICIAL FEMORAL ARTERY, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH UNRAVELED AND SEPARATED UPON REMOVAL OF THE DEVICE. THE DEVICE WAS FLUSHED AND INSERTED OVER A BENTSON WIRE THROUGH THE LEFT COMMON FEMORAL ARTERY. RESISTANCE WAS ENCOUNTERED UPON INITIAL ADVANCEMENT. THE ANATOMY WAS REPORTEDLY HEAVILY CALCIFIED AROUND THE JUNCTION OF THE INTERNAL AND EXTERNAL ILIAC ARTERIES. UPON MEETING RESISTANCE, THE USER STOPPED ADVANCING THE SHEATH AND INJECTED CONTRAST TO VISUALIZE UNDER FLUOROSCOPY. DURING ATTEMPTED REMOVAL OF THE DEVICE, THE SHAFT UNRAVELED AND SEPARATED, LEAVING APPROXIMATELY FIVE TO EIGHT CENTIMETERS OF THE SHEATH IN THE PATIENT. THE DILATOR AND WIRE GUIDE WERE IN THE LUMEN OF THE SHEATH AT THE TIME OF SEPARATION. THE USER ATTEMPTED TO SNARE THE SEPARATED FRAGMENT WITH MULTIPLE DEVICES BUT WAS UNSUCCESSFUL. THE PATIENT WAS TRANSFERRED FROM THE OUTPATIENT CENTER TO THE HOSPITAL ACROSS THE STREET FOR SURGICAL REMOVAL. THE SEPARATED FRAGMENT WAS SUCCESSFULLY REMOVED DURING AN ENDARTERECTOMY WITH PATCH REPAIR.

  Patient problems: Foreign Body In Patient

  MAUDE report 13402351 ↗
• MalfunctionNov 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745843 ↗
• MalfunctionJul 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT: AFTER THE STENT WAS REMOVED, ANOTHER COOK SHEATH WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12145273 ↗
• MalfunctionOct 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10648860 ↗
• MalfunctionAug 19, 2020Separation Problem; Separation Problem

  AS REPORTED, DURING AN UNKNOWN PROCEDURE OF THE LEG A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH SEPARATED AT THE HUB. THE USER GAINED ACCESS IN THE RIGHT GROIN, WHICH WAS NOTED TO BE HEAVILY SCARRED, AND FELT RESISTANCE. AS THE SHEATH WAS BEING REMOVED, THE USER AGAIN FELT RESISTANCE, THE SHEATH SEPARATED AT THE HUB. NO PORTION OF THE DEVICE WAS LEFT INSIDE THE PATIENT. THIS DID NOT RESULT IN ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10427157 ↗
• InjuryFeb 3, 2020Material Separation; Unraveled Material; Material Separation; Unraveled Material

  AS REPORTED, AT THE BEGINNING OF AN INTERVENTIONAL LASER PROCEDURE INVOLVING THE LEFT LEG, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH SEPARATED AT THE SHAFT AFTER BEING ADVANCED OVER THE BIFURCATION. ACCESS WAS OBTAINED IN THE RIGHT GROIN. THE SHEATH, AS WELL AS AN UNSPECIFIED MPA CATHETER AND UNSPECIFIED 0.035 INCH J-WIRE, WERE INSERTED AND ADVANCED TO THE LEFT LEG FOR DIAGNOSTIC IMAGING. ANOTHER MANUFACTURER'S 0.014 INCH WIRE GUIDE WAS INSERTED; HOWEVER, THE WIRE WOULD NOT TRACK. IMAGING PERFORMED AT THAT TIME DEMONSTRATED COILING OF THE COMPLAINT DEVICE, WHICH HAD BEEN INSERTED TO 55 CENTIMETERS. THE 0.014 INCH WIRE WAS REMOVED AND THE J-WIRE WAS REINSERTED WITH HOPES TO RETRIEVE THE SEPARATED PORTION OF THE SHEATH. THE DEVICE WAS NOT ABLE TO BE RETRIEVED WITH THE WIRE, AND REPORTEDLY THREE-FOURTHS OF THE SHEATH REMAINED IN THE PATIENT. ANOTHER PHYSICIAN WAS CALLED TO ASSIST AND ACCESS WAS OBTAINED ON THE LEFT SIDE WITH AN UNKNOWN 10 FRENCH SHEATH. THE SEPARATED PORTION OF THE SHEATH, ALONG WITH THE J-WIRE, WERE ABLE TO BE SNARED FROM THE PATENT AND REMOVED THROUGH THE 10 FRENCH SHEATH. BOTH THE RIGHT AND LEFT ACCESS SITES WERE CLOSED USING CLOSURE DEVICES. THE ANATOMY WAS NOT REPO

  Patient problems: No Code Available

  MAUDE report 9660687 ↗
• MalfunctionAug 2, 2019Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED 12SEP2019 STATING THAT NO MALFORMATIONS OR DAMAGE WAS OBSERVED TO THE DEVICE PRIOR TO ITS INITIAL HANDLING. NO FURTHER INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8855279 ↗
• InjuryApr 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, A (B)(6) MALE WAS UNDERGOING A LEFT LOWER EXTREMITY ANGIOGRAM USING A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH. THE COMPLAINT SHEATH WAS INSERTED IN THE SCARRED AND CALCIFIED RIGHT GROIN, UP AND OVER THE AORTIC BIFURCATION AND ADVANCED TO THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE UNSPECIFIED WIRE WAS EXCHANGED FOR ANOTHER MANUFACTURER'S 300CM WIRE, WHICH WAS ADVANCED TO THE LEFT PERONEAL ARTERY. PHYSICIAN ATTEMPTED TO WITHDRAW THE COMPLAINT DEVICE TO THE LEFT COMMON FEMORAL ARTERY (CFA) AT WHICH POINT THE VALVE/HUB POPPED OFF OF THE SHEATH. REMOVAL WAS ATTEMPTED BY PULLING ON THE HUB. THE COMPLAINT SHEATH HAD BEEN IN PLACE APPROXIMATELY THIRTY MINUTES AT THIS POINT. THE DILATOR WAS NOT IN PLACE AT THE TIME OF REMOVAL AND SOME RESISTANCE WAS FELT. PATIENT WAS THEN TRANSPORTED TO THE HOSPITAL AND THE PROCEDURE WAS COMPLETED AND THE SHEATH WAS REMOVED SUCCESSFULLY. AFTER THE COMPLAINT DEVICE WAS REMOVED, THE PATIENT'S HEMOGLOBIN DROPPED FROM 11 TO 8. THE PATIENT REFUSED A TRANSFUSION AND WAS DISCHARGED FROM THE HOSPITAL TWENTY-FOUR HOURS POST-PROCEDURE. THE COMPLAINT DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER TO AID IN THE INVESTIGATION.

  Patient problems: No Code Available

  MAUDE report 8550763 ↗
• InjuryMar 12, 2019Material Separation; Material Separation

  IT WAS REPORTED, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH COMPLETELY BROKE OFF INSIDE A PATIENT OF UNSPECIFIED GENDER AND AGE BUT WAS SUCCESSFULLY RETRIEVED IN AN UNKNOWN MANNER. THE UNSPECIFIED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A GOOD PATIENT OUTCOME. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE. NO FURTHER INFORMATION IS AVAILABLE. THE COMPLAINT DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER TO AID IN THE INVESTIGATION.

  Patient problems: No Code Available

  MAUDE report 8413692 ↗
• MalfunctionMay 10, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT AT THE END OF A LOWER EXTREMITY ANGIOGRAM PROCEDURE, THE CHECK-FLO HUB BROKE OFF THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH. THE COMPLAINT DEVICE WAS INTRODUCED THROUGH THE RIGHT COMMON FEMORAL ARTERY IN THE IPSELATERAL APPROACH AND WAS CURVED AND TAPED DOWN TO THE DRAPE. ANOTHER MANUFACTURER'S 7MM X 250MM STENT WAS USED THROUGH THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH. AFTER REMOVAL, ANOTHER FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENTS ANATOMY. NO ADVERSE EFFECTS WERE REPORTED AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7503128 ↗
• MalfunctionMay 17, 2017Material Deformation

  THE REPORT INDICATED THAT DURING ANGIOGRAPHY OF THE LOWER EXTREMITIES, UPON UPSIZING FROM A 5.0FR TO A7.0FR SHEATH IN THE COMMON FEMORAL ARTERY, THE DISTAL TIP ACCORDIONED AT THE TRANSITION POINT WITH THE DILATOR. IMAGES OF THE COMPLAINT DEVICE DEPICT THE TIP ACCORDIONED AND HAVING A HANGNAIL APPEARANCE. THE REPORTER INDICATED THAT THE ACCESS SITE WAS POSSIBLY SCARRED. 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 Consequences Or Impact To Patient

  MAUDE report 6573288 ↗
• MalfunctionMay 17, 2017Failure to Advance; Deformation Due to Compressive Stress

  THE INFORMATION PROVIDED INDICATED THAT DURING A PROCEDURE ON THE LEFT SUPERFICIAL FEMORAL ARTERY VIA THE RIGHT SIDE, THE SHEATH COULD NOT BE INTRODUCED INTO THE BODY AS THE LIP OF THE SHEATH CRIMPED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A COMPETITOR¿S PRODUCT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY AND 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 Known Impact Or Consequence To Patient

  MAUDE report 6572705 ↗
• MalfunctionMay 16, 2017Stretched; Material Integrity Problem

  THE SHEATH BUCKLED ON TOP OF THE DILATOR UPON INTRODUCTION INTO THE SKIN FROM THE LOWER EXTREMITY, AND THE TIP OF THE SHEATH BECAME NICKED AND STRETCHED. A NEW DEVICE WAS USED TO COMPLETE THE INTENDED PROCEDURE. IT WAS NOTED THE PATIENTS ANATOMY WAS TORTUOUS OR CALCIFIED. 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 Consequences Or Impact To Patient

  MAUDE report 6569201 ↗
• MalfunctionMay 16, 2017Deformation Due to Compressive Stress

  IT WAS REPORTED THE END OF THE SHEATH BUCKLED AT THE TRANSITION POINT BETWEEN THE DILATOR AND SHEATH AS IT WAS BEING ADVANCED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. VISUAL INSPECTION CONFIRMS THE SHEATH TIP WAS BUCKLED, OUT OF ROUND AND STRETCHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6568540 ↗
• MalfunctionMay 16, 2017Split; Physical Property Issue

  IT WAS REPORTED THAT DURING A PERIPHERAL LOWER EXTREMITY PROCEDURE ON A PATIENT OF UNKNOWN AGE AND GENDER, THE DISTAL TIP OF THE SHEATH BUCKLED ON TOP OF THE INNER DILATOR WHICH CREATED A BUMP ON THE SHEATH. THE PHYSICIAN REMOVED THE DEVICE AND USED ANOTHER OF THE SAME TO COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. VISUAL EXAM FOUND THE SHEATH DISTAL TIP TO HAVE NICKS, SPLITS, AND HANGNAIL DAMAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6568450 ↗
• MalfunctionMay 15, 2017Material Frayed; Failure to Advance

  THE INFORMATION RECEIVED INDICATED THAT THE DILATOR IN THE INTRODUCER WOULD NOT PASS THE SKIN INTO THE FEMORAL ARTERY. AS A RESULT, IT WAS PULLED OFF THE WIRE AND THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IMAGES OF THE DEVICE EXHIBITED FRAYED EDGES AT THE TIP OF THE SHEATH. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT RELATED TO THE OCCURRENCE, NO ADDITIONAL PROCEDURE AND NO COMPONENTS OF THE DEVICE LEFT IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6567442 ↗
• MalfunctionMay 15, 2017Material Deformation

  PHYSICIAN HAD ACCESS IN THE COMMON FEMORAL ARTERY WITH A GLIDE WIRE UP AND OVER THE BIFURCATION. TECH PREPPED THE SHEATH AND HAD DILATOR LOADED INTO THE SHEATH. AT THE POINT WHERE THE SHEATH WAS GOING TO BE LOADED ONTO THE WIRE, THE PHYSICIAN NOTED THE TIP OF SHEATH LOOKED TO HAVE A DEFORMITY. THE SHEATH WAS NOT ADVANCED INTO THE PATIENT. A NEW SHEATH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. IMAGES OF THE DEVICE DEPICTED JAGGED EDGES AT THE TIP OF SHEATH. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6567349 ↗
• MalfunctionFeb 16, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ANGIOGRAM OF THE LEG, THE WIRE BECAME STUCK ON ANOTHER MANUFACTURER'S ATHERECTOMY DEVICE. WHEN PULLING THE WIRE OUT, A PIECE OF THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH WAS BROKEN OFF AND CAME OUT ON THE WIRE. NO FRAGMENTS REMAINED WITHIN THE PATIENT. NO ADDITIONAL DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6335229 ↗
• MalfunctionJan 31, 2017Material Separation; Material Separation

  IT WAS REPORTED, UPON OPENING THE PACKAGE, IT WAS NOTED THAT THE CHECK FLO VALVE WAS SEPARATED FROM THE SHEATH. PRIOR TO PATIENT USAGE, NO ADDITIONAL DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Patient Involvement

  MAUDE report 6291728 ↗
• MalfunctionJan 31, 2017Material Separation; Material Separation

  CUSTOMER REPORTED THAT THE TIP OF THE CATHETER SEPARATED WHILE THE USER WAS HAND MOLDING THE DEVICE FOR SPECIFIC USE. THE EVENT OCCURRED DURING DEVICE / PROCEDURE PREPARATION. THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT. A REPLACEMENT DEVICE WAS OBTAINED AND USED TO COMPLETE THE PROCEDURE. NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 2/6/2017: CUSTOMER REPORTED THAT THE DEVICE SEPARATED WHEN WITHDRAWING FROM THE CONTRALATERAL LIMB. THE DEVICE WAS PLACED THROUGH A LEFT FEMORAL ARTERY ACCESS TO THE RIGHT LOWER EXTREMITY. A DILATOR AND WIRE WERE INSERTED INTO THE LUMEN OF THE SHEATH PRIOR TO REMOVAL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6291716 ↗