Flexor G44153Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00827002441538), received between Jan 30, 2017 and Mar 12, 2026 — classified as 8 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Break

  AS REPORTED, DURING A LOWER EXTREMITY ANGIOGRAM WITH POSSIBLE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY VIA ACCESS IN THE LEFT COMMON FEMORAL ARTERY, A FLEXOR ANSEL GUIDING SHEATH UNRAVELED AND SEPARATED. THE AORTA WAS ¿VERY, VERY CALCIFIED¿ AND THE BIFURCATION WAS ACUTE. REPORTEDLY, THE DILATOR WAS INSERTED, AND THE USER ATTEMPTED TO WITHDRAW THE SHEATH; HOWEVER, THE SHEATH STUCK AT THE AORTIC BIFURCATION AND BEGAN TO UNRAVEL AND BREAK. ACCESS WAS OBTAINED IN THE RIGHT GROIN WITH A 7-FRENCH SHEATH, AND ADVANCED VASCULAR PROCEDURES WERE USED TO SNARE THE WIRE GUIDE AND REMOVE THE SEPARATED SHEATH FROM THE ¿OTHER SIDE¿. PER THE REPORTER, THE SHEATH, WHICH WAS RETRIEVED IN MULTIPLE PIECES, WAS ENTIRELY REMOVED FROM THE PATIENT, AND NO FOREIGN BODY WAS RETAINED. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579228 ↗
• MalfunctionMar 2, 2026Break

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, A FLEXOR ANSEL GUIDING SHEATH SEPARATED. CONTRALATERAL ACCESS WAS OBTAINED IN THE FEMORAL ARTERY. THE BIFURCATION WAS NOT STEEP/ACUTE OR CALCIFIED. ANOTHER MANUFACTURER¿S LASER AND INTRAVENOUS ULTRASOUND (IVUS), AS WELL AS AN UNSPECIFIED BALLOON AND ANOTHER MANUFACTURER¿S WIRE, WERE USED THROUGH THE SHEATH DURING THE PROCEDURE. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR ADVANCEMENT OF THE SHEATH, NOR DURING INSERTION OR ADVANCEMENT OF ANY DEVICE THROUGH THE SHEATH. THE SHEATH SEPARATED, WITH THE IVUS AND WIRE IN THE LUMEN, AS THE PHYSICIAN USED THE IVUS AND PULLED BACK ON THE RUN THROUGH WIRE. PER THE REPORTER, THE USER REMOVED THE SHEATH BY PULLING THE FIRST HALF AT THE HUB AND USING A CLAMP TO REMOVE THE REST OF THE DEVICE. RESISTANCE WAS ENCOUNTERED UPON SHEATH REMOVAL. A SHORT SHEATH WAS INSERTED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT IS REPORTEDLY "FINE". 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 24483327 ↗
• MalfunctionOct 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING ANGIOGRAPHY OF THE RENAL ARTERY, A FLEXOR ANSEL GUIDING SHEATH LEAKED. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372745 ↗
• InjuryJul 16, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED 16JUL2024. THE PROCEDURE WAS PERFORMED USING INTRAVENOUS CONSCIOUS SEDATION, AND PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED. ONE-PERCENT LIDOCAINE WAS ADMINISTERED SUBCUTANEOUSLY, AND A SMALL INCISION WAS MADE, FOLLOWED BY BLUNT DISSECTION USING ARTERIAL FORCEPS, UNDER ULTRASOUND GUIDANCE. ULTRASOUND-GUIDED, RETROGRADE ACCESS WAS OBTAINED IN THE ¿FEMERO-BYPASS HOOD REGION¿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

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Thrombosis/Thrombus

  MAUDE report 19750017 ↗
• MalfunctionJun 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, A FLEXOR ANSEL GUIDING SHEATH'S VALVE LEAKED AND WOULD NOT MAINTAIN HEMOSTASIS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

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

  MAUDE report 19478660 ↗
• MalfunctionAug 25, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  AS ORIGINALLY REPORTED, PRIOR TO USE DURING AN ENDOVASCULAR REVASCULARIZATION PROCEDURE OF THE LEFT LEG, VIA ACCESS IN THE RIGHT GROIN, THE TIP OF A FLEXOR ANSEL GUIDING SHEATH WAS FOUND TO BE "FAULTY" UPON OPENING THE DEVICE PACKAGE. A WIRE WOULD NOT PASS THROUGH THE DAMAGED TIP. 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. UPON RETURN AND EVALUATION OF THE DEVICE ON (B)(6) 2023, ONE OF THE DILATORS WAS SPLIT AT THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17624896 ↗
• MalfunctionAug 24, 2023Break; Break

  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 17618495 ↗
• MalfunctionJul 13, 2023Break; Stretched; Unraveled Material; Break; Stretched; Unraveled Material

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, A FLEXOR ANSEL GUIDING SHEATH UNRAVELED AND SEPARATED. ACCESS WAS OBTAINED IN THE LEFT COMMON FEMORAL ARTERY TO TARGET THE RIGHT FEMORAL ARTERY. THE PATIENT HAD MULTIPLE PREVIOUSLY PLACED STENTS, INCLUDING BILATERAL STENTS IN THE COMMON ILIAC ARTERIES, AS WELL AS A HIGHLY CALCIFIED LESION ON THE AFFECTED SIDE. RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE SHEATH AS THE USER PULLED THE SHEATH BACK FROM THE RIGHT FEMORAL ARTERY, WITHOUT THE DILATOR IN PLACE. THE SHEATH THEN BROKE IN THREE PLACES. THE PATIENT IS REPORTEDLY "OK," AND THE OUTCOME WAS DESCRIBED AS GOOD. 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. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE SHEATH WAS UNRAVELED AND SEPARATED IN THREE PLACES. STRETCHING AND ELONGATION WERE ALSO NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17318744 ↗
• InjuryMay 25, 2022Break; Peeled/Delaminated; Unraveled Material; Break; Peeled/Delaminated; Unraveled Material

  AS REPORTED, DURING AN AORTOGRAM OF THE RIGHT EXTREMITY, VIA LEFT-SIDED ACCESS, A FLEXOR ANSEL GUIDING SHEATH SEPARATED IN THE PATIENT UPON REMOVAL OF THE DEVICE. THE VESSELS WERE REPORTEDLY EXTREMELY CALCIFIED, AND RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE SHEATH. THE SEPARATED PORTION OF THE DEVICE WAS REMOVED FROM THE PATIENT WITH A CLOVERSNARE. THE PROCEDURE WAS COMPLETED AT THE TIME OF THE SEPARATION. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, IT WAS NOTED THAT THE SHEATH HAD ALSO UNRAVELED AND DELAMINATED AT THE POINT OF SEPARATION. 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: Foreign Body In Patient

  MAUDE report 14495793 ↗
• InjuryMar 24, 2022Break; Unraveled Material; Break; Unraveled Material

  AS REPORTED, DURING A BLOW-THE-KNEE REVASCULARIZATION PROCEDURE, A FLEXOR ANSEL GUIDING SHEATH SEPARATED. HEPARIN WAS GIVEN FOR ANTICOAGULATION. ACCESS WAS OBTAINED IN THE RIGHT GROIN, WHICH WAS REPORTEDLY VERY SCARRED AND HARD FROM A PREVIOUS FEMORAL-POPLITEAL PROCEDURE. RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OF THE SHEATH, AS THE PHYSICIAN REPORTEDLY ANTICIPATED DIFFICULT ACCESS AND USED AN UNKNOWN 6 FRENCH DILATOR TO DILATE THE ACCESS SITE PRIOR TO ADVANCING THE SHEATH. A CONTRALATERAL APPROACH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE, TREATING THE LEFT SUPERFICIAL FEMORAL ARTERY AND LESIONS BELOW THE KNEE WITH ANGIOPLASTY AND ATHERECTOMY. ADVANCEMENT OF THE SHEATH OVER THE BIFURCATION WAS DESCRIBED AS VERY MINIMALLY CHALLENGING. UPON REMOVAL OF THE SHEATH OVER AN AMPLATZ WIRE WITH A FLOPPY TIP, THE SHEATH UNRAVELED AND SEPARATED TWELVE-TO-FIFTEEN CENTIMETERS FROM THE HUB. THE DILATOR WAS NOT REINSERTED INTO THE SHEATH PRIOR TO REMOVAL AND WAS NOT IN THE SHEATH LUMEN AT THE TIME OF SEPARATION. PER THE REPORTER, THE PHYSICIAN WAS VERY CAUTIOUS WHEN REMOVING THE SHEATH, AS HE KNEW IT COULD BREAK, SO HE PULLED FROM THE PROXIMAL SHAFT, WITHOUT USE OF FORCE. UNRAVELED C

  Patient problems: Foreign Body In Patient

  MAUDE report 13890816 ↗
• InjuryJul 28, 2021Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12240099 ↗
• InjuryMay 14, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION WAS RECEIVED 26MAY2021. THE PATIENT RECEIVED HEPARIN DURING THE PROCEDURE. TWO UNITS OF PACKED RED BLOOD CELLS WERE ADMINISTERED DUE TO BLOOD LOSS. THE OTHER MANUFACTURER'S 5-MILLIMETER BALLOON WAS DEFLATED PRIOR TO ATTEMPTED REMOVAL, AND DEFLATION WAS CONFIRMED USING FLUOROSCOPY.

  Patient problems: Hematoma

  MAUDE report 11824610 ↗
• MalfunctionApr 28, 2021Unraveled Material; Unraveled Material

  AS REPORTED, A PHYSICIAN PLACED A MEDTRONIC PTA BALLOON THROUGH A COOK FLEXOR ANSEL GUIDING SHEATH. FEMORAL ACCESS WAS GAINED FOR A TARGET LESION IN THE SFA. THE BALLOON WAS INFLATED IN THE SUPERIOR FEMORAL ARTERY AND REMAINED INFLATED FOR 3 MINUTES. THE BALLOON WAS THEN DEFLATED AND ATTEMPTED TO BE REMOVED. THE BALLOON WAS STUCK AT THE VALVE OF THE SHEATH, AND THEREFORE THE COMPLETE UNIT HAD TO REMOVED TOGETHER. NO SEPARATION WAS NOTED. BASED UPON REVIEW OF THE PRELIMINARY INVESTIGATION, WHAT WAS INITIALLY REPORTED IS NOT ENTIRELY ACCURATE AND THE INNER LINER WAS PULLING OUT FROM THE VALVE. 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 11740044 ↗
• MalfunctionMar 25, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  INFORMATION WAS AVAILABLE AND INADVERTENTLY OMITTED FROM THE INITIAL REPORT. ACCESS WAS OBTAINED IN THE LEFT GROIN AND THE TARGET LESION WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY. THE COMPLAINT DEVICE WAS IN PLACE FOR APPROXIMATELY TWO HOURS. THE VESSELS WERE CALCIFIED, AND A PREVIOUSLY OCCLUDED STENT WAS BALLOONED JUST PRIOR TO REMOVAL OF THE OTHER MANUFACTURER'S BALLOON FROM THE SHEATH. THE BALLOON AND WIRE WERE REMOVED AS A UNIT FROM THE SHEATH, AND A NEW COOK SHEATH WAS OPENED AND ADVANCED OVER THE WIRE GUIDE TO CONTINUE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11569067 ↗
• MalfunctionFeb 24, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11372610 ↗
• InjuryDec 15, 2020Material Separation; Unraveled Material; Material Separation; Unraveled Material

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Code Available

  MAUDE report 11010688 ↗
• MalfunctionFeb 28, 2020Stretched; Stretched

  ADDITIONAL INFORMATION WAS RECEIVED 18MAR2020. THE ACCESS SITE WAS THE LEFT FEMORAL ARTERY. PER THE USER, THE PDA WAS TOO BIG FOR THE LARGEST PLUG AVAILABLE; THEREFORE THE PHYSICIANS WERE DISCUSSING STRATEGIES TO CLOSE THE PDA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9770909 ↗
• MalfunctionSep 18, 2019Material Separation; Detachment of Device or Device Component; 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 Consequences Or Impact To Patient

  MAUDE report 9083090 ↗
• MalfunctionDec 14, 2018Crack; Crack

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8166068 ↗
• InjuryOct 16, 2018Stretched; Unraveled Material; Detachment of Device or Device Component; Stretched; Unraveled Material; Detachment of Device or Device Component

  IT WAS REPORTED, A PATIENT OF UNKNOWN AGE AND GENDER WAS UNDERGOING AN ANGIOGRAM PROCEDURE OF THE RIGHT LEG VIA THE LEFT GROIN TO THE COMMON FEMORAL ARTERY. WHILE REMOVING THE 5FR FLEXOR ANSEL GUIDING SHEATH OVER AN AMPLATZ WIRE, THE HUB SEPARATED FROM THE COMPLAINT SHEATH. AS THE PHYSICIAN CONTINUED TO REMOVE THE COMPLAINT DEVICE, IT STARTED UNRAVELING IN A SPIRAL FASHION INSIDE THE PATIENT'S ANATOMY BUT, WAS ABLE TO BE COMPLETELY REMOVED. AS A RESULT, GROIN ACCESS WAS LOST . THE PHYSICIAN DECIDED TO STOP THE PROCEDURE AND WILL RESCHEDULE ONCE THE LEFT GROIN IS HEALED. ACCORDING TO THE COMPLAINANT, THE DILATOR WAS IN PLACE DURING THE REMOVAL OF THE COMPLAINT DEVICE. IT IS UNKNOWN IF THERE WAS ANY VESSEL CALCIFICATION. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 7971097 ↗
• InjuryFeb 27, 2018Migration or Expulsion of Device; Material Separation; Migration or Expulsion of Device; Material Separation

  IT WAS REPORTED THAT DURING TREATMENT OF A CHRONIC TOTAL OCCLUSION (CTO) OF THE SUPERFICIAL FEMORAL ARTERY (SFA), SERIAL BALLOON CATHETER (OTHER MANUFACTURER) INFLATIONS WERE PERFORMED ALONG THE LENGTH OF THE CTO WITH BALLOON SIZE ESCALATION. WHILE ATTEMPTING TO EXCHANGE THE BALLOON CATHETER AND PASS ANOTHER MANUFACTURER'S 5.0 BY 100 MILLIMETER (MM) BALLOON CATHETER, THE 5 FR FLEXOR ANSEL GUIDING SHEATH BEING UTILIZED FRACTURED AT THE STEM VALVE AND MIGRATED INTO THE PATIENT'S RIGHT ILIAC ARTERY. ACCESS WAS MAINTAINED WITH A WIRE GUIDE AND INTERVENTIONAL RADIOLOGY WAS USED TO SUCCESSFULLY RETRIEVE THE SHEATH USING A 10 MM GOOSENECK SNARE (MANUFACTURER UNSPECIFIED) AND 8 FR SHEATH (MANUFACTURER UNSPECIFIED) TO PULL THE FRACTURED PORTION THROUGH. THE PROCEDURE ENDED AT THIS POINT AND THE PATIENT HAD A LARGE HEMATOMA, WHICH REQUIRED ADDITIONAL BED REST. THE COMPLAINANT STATED THAT THE 5.0 BY 100 MM BALLOON WAS COMPATIBLE WITH THE FLEXOR ANSEL GUIDING SHEATH, AND THAT THE PROCEDURE WAS 75 PERCENT COMPLETED WHEN THE SHEATH FRACTURED; THE PROCEDURE ENDED ONCE THIS EVENT OCCURRED. IT WAS NOTED THAT MULTIPLE EXCHANGES THROUGH THE SHEATH HAD BEEN PERFORMED. THE SHEATH WAS PLACED IN THE RIGH

  Patient problems: No Code Available

  MAUDE report 7299745 ↗
• MalfunctionJun 13, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING PERIPHERAL INTERVENTION THE MEDICAL TEAM OPENED THE FLEXOR ANSEL GUIDING SHEATH AND NOTED THE TIP TO BE PINCHED OFF . THE WIRE WOULD NOT THREAD THROUGH THE INTRODUCER. THE DEVICE WAS NOT USED FOR THE PROCEDURE. THE REPORTED EVENT OCCURRED PRIOR TO PATIENT CONTACT. THE MANUFACTURER'S DEVICE EVALUATION RESULTS CONFIRMED THE DAMAGE TO THE TIP OF THE COMPLAINT DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6639026 ↗
• MalfunctionMay 16, 2017Break

  AFTER OPENING THE STERILE PACKET FOR THE DILATOR, THE NURSE NOTICED THAT THE TIP OF THE DILATOR WAS SMASHED AND RAGGED. THE DECISION WAS MADE NOT TO USE THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6569235 ↗
• MalfunctionMay 15, 2017Detachment Of Device Component; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANS-LUMINAL ANGIOPLASTY PROCEDURE, THE PHYSICIAN ACCESSED THE SHEATH USING THE DILATOR. HOWEVER, UPON ATTEMPTING TO INSERT THE SHEATH INTO THE PATIENT'S SKIN, RESISTANCE WAS ENCOUNTERED. AS A RESULT, THE PHYSICIAN PULLED OUT THE SHEATH. IT WAS NOTED THERE WAS A GAP BETWEEN THE DILATOR AND THE SHEATH WHICH CAUSED DIFFICULTY INSERTING THE SHEATH INTO THE PATIENT'S SKIN. ANOTHER DEVICE WAS USED FOR THE PROCEDURE. INSPECTION OF THE DEVICE IDENTIFIED THE SHEATH WAS OUT-OF-ROUND AND HAD THREE NOTICEABLE NICKS IN THE TIP. 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 6566987 ↗
• MalfunctionMay 15, 2017Kinked; Failure to Advance

  IT WAS REPORTED THE INTRODUCER WAS NOT WORKING AS THE TIP OF THE DILATOR WAS KINKED AND PASSAGE WAS NOT POSSIBLE. THIS ISSUE WAS REPORTED TO HAVE OCCURRED PRIOR TO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6566726 ↗