Micropuncture G48003Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 00827002480032), received between Oct 8, 2014 and Sep 11, 2025 — classified as 25 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Material Separation” (33 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 78 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2025Unraveled Material; Unraveled Material

  AS REPORTED, PRIOR TO USE FOR AN UNSPECIFIED PROCEDURE RELATED TO PERIPHERAL ARTERY DISEASE, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET¿S WIRE WAS DESCRIBED AS ¿COMPLETELY FRAYED¿, ¿DETERIORATED¿, AND ¿DISHEVELED¿, AND COULD NOT BE USED. THE DEVICE DID NOT MAKE PATIENT CONTACT. 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 23027038 ↗
• InjuryApr 29, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED 20MAY2025. THE PROCEDURE WAS AN ANGIOGRAM OF THE LEG WITH ANGIOPLASTY AND STENT PLACEMENT, VIA INTRAVENOUS SEDATION. PER THE PHYSICIAN, THE CASE WAS ¿SO INCREDIBLY CHALLENGING FOR MULTIPLE REASONS.¿ LOCAL ANESTHETIC WAS USED WITHIN THE SKIN AND SUBCUTANEOUS TISSUES OVER THE LEFT COMMON FEMORAL ARTERY (LCFA). ULTRASOUND-GUIDED PERCUTANEOUS ACCESS WAS OBTAINED IN THE LCFA, AND BLOOD RETURN WAS NOTED UPON INSERTION OF THE ACCESS NEEDLE, PRIOR TO WIRE ADVANCEMENT. PER THE PHYSICIAN, THE SCAR TISSUE IN THE LEFT GROIN WAS SO DENSE FROM MULTIPLE PRIOR SURGERIES, INCLUDING A FEMORAL ENDARTERECTOMY AND A LEFT-TO-RIGHT FEMORAL-FEMORAL BYPASS, THAT A MICRO-SHEATH WOULD NOT ADVANCE. THE PHYSICIAN THEN USED THE STIFF MICROPUNCTURE SHEATH, WHICH WENT THROUGH THE SCAR TISSUE OVER THE WIRE AFTER MULTIPLE ATTEMPTS; HOWEVER, IT BECAME STUCK IN THE SCAR TISSUE AND COULD NOT BE REMOVED. AFTER MULTIPLE ATTEMPTS TO REMOVE THE WIRE AND SHEATH (OUTER CANNULA), THEY BROKE OFF TOGETHER AND BECAME EMBEDDED IN THE SCAR TISSUE. PER THE REPORTER, APPROXIMATELY ONE CENTIMETER OF THE WIRE REMAINED IN THE LUMEN OF THE ARTERY. THE PHYSICIAN THEN ATTEMPTED TO ACCESS THE VERY DISTA

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928655 ↗
• InjuryDec 6, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, DURING A FISTULAGRAM, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET¿S SHEATH WAS INADVERTENTLY/ACCIDENTALLY TRANSECTED/CUT BY THE USER. PER THE REPORTER, THE FISTULA HAD BEEN EXTENSIVELY STENTED AT ANOTHER FACILITY, EXCEPT FOR APPROXIMATELY ONE CENTIMETER OF THE MID-FISTULA, WHICH IS WHERE ACCESS WAS OBTAINED FOR THE FISTULAGRAM. THE FISTULAGRAM SHOWED NARROWING OF THE STENTS. THE PATIENT HAD SEVERE ULNAR DISEASE, AND THE MAIN FLOW TO THE HAND WAS THE RADIAL ARTERY. SEVERE ¿STEAL¿ WAS NOTED DUE TO THE FISTULA. REPORTEDLY, THERE WAS NO OPTION FOR PLICATION, AS THE FISTULA WAS EXTENSIVELY STENTED, AND PATENCY OF THE FISTULA WAS ALSO POOR DUE TO THE EXTENT OF STENTING. THEREFORE, THE USER DECIDED TO LIGATE THE FISTULA. PER THE REPORTER, THE ONLY AREA TO LIGATE WAS WITHIN THE SAME AREA AS THE ACCESS SITE, WHERE THE COMPLAINT DEVICE WAS LOCATED. DURING DISSECTION OF THE TISSUES, BLEEDING WAS REPORTED. AS THE USER DISSECTED TO GAIN CONTROL OF THE BLEEDING, THE SHEATH WAS INADVERTENTLY TRANSECTED. THE USER WAS UNABLE TO LOCATE THE DISTAL TIP OF THE SHEATH. AN ULTRASOUND OF THE ARM WAS PERFORMED, AS WELL AS INTRAVENOUS ULTRASOUND, TRANSESOPHAGEAL ECHOCARDIOGRAM,

  Patient problems: Foreign Body Embolism; Foreign Body In Patient

  MAUDE report 20866639 ↗
• InjuryNov 13, 2024Break; Break

  AS REPORTED, DURING AN ANGIOGRAM OF THE LOWER LEG, A MICROPUNCTURE TRANSITION LESS STIFFENED CANNULA ACCESS SET¿S WIRE "SHEARED OFF¿/SEPARATED UPON REMOVAL OF THE WIRE THROUGH THE ACCESS NEEDLE. ULTRASOUND-GUIDED ACCESS WAS REPORTEDLY OBTAINED IN THE LEFT POPLITEAL VEIN, AND BLOOD RETURN WAS NOTED UPON INSERTION OF THE ACCESS NEEDLE, PRIOR TO ADVANCEMENT OF THE WIRE GUIDE. RESISTANCE WAS ENCOUNTERED UPON INSERTION OF THE DEVICE, AND THE ANATOMY WAS REPORTEDLY CALCIFIED AND CHRONICALLY OCCLUDED. PER THE REPORTER THE SEPARATED TIP OF THE WIRE WAS LEFT IN THE ADVENTITIA OF THE POPLITEAL VEIN, AS IT WAS NOT EXPECTED TO CAUSE ADVERSE EFFECTS. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE WIRE WAS RETURNED WITHIN THE SHEATH, NOT THE NEEDLE. THE WIRE WAS UNRAVELED AND SEPARATED, AND THE SHEATH TIP WAS EXTREMELY DAMAGED/DISTORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20674023 ↗
• InjuryNov 5, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE HUB OF A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S DILATOR SEPARATED UPON REMOVAL. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY. THE NEEDLE WAS INSERTED, FOLLOWED BY THE WIRE GUIDE. THE NEEDLE WAS THEN REMOVED, AND THE DILATOR AND SHEATH WERE INSERTED OVER THE WIRE. WHEN THE USER REMOVED THE DILATOR, THE HUB SEPARATED AS THE DILATOR WAS PULLED FROM THE PATIENT, AND THE DILATOR SHAFT WAS "LOST" INSIDE THE PATIENT'S BODY IN THE "GROIN AREA." THE PATIENT REPORTEDLY HAD TO GO INTO SURGERY IN ORDER FOR THE PHYSICIANS TO LOOK FOR THE BROKEN DILATOR. THE OUTCOME IS UNKNOWN AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 20614195 ↗
• MalfunctionSep 16, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  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 20231029 ↗
• MalfunctionSep 16, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  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 20228861 ↗
• MalfunctionJan 26, 2024Unsealed Device Packaging; Unsealed Device Packaging

  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 18589749 ↗
• MalfunctionOct 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED 16OCT2023. THE PROCEDURE INVOLVED VASCULAR INTERVENTION. UPON ADVANCEMENT OF THE STIFFENED CANNULA INTO THE FEMORAL ARTERY, THE OUTER CANNULA'S HUB SEPARATED. THE GROIN ACCESS SITE WAS SCARRED. THE DEVICE WAS NOT ADVANCED OR REMOVED THROUGH A PREVIOUSLY PLACED CLOSURE DEVICE. A NEW SET WAS OPENED AND USED TO COMPLETE THE PROCEDURE. 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 OCCURRENCE.

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

  MAUDE report 17931813 ↗
• MalfunctionMay 25, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  AS REPORTED, FOLLOWING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND USING A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET, THE INTRODUCER SHAFT TORE OFF THE HEAD OF THE INTRODUCER WHEN ATTEMPTING TO REMOVE THE DEVICE. THE ACCESS SITE WAS THE FEMORAL ARTERY, AND IT WAS VERY SCARRED AND CALCIFIED. THE INITIAL PUNCTURE WENT AS PLANNED, AND THERE WERE NO ISSUES WHILE INSERTING THE WIRE AND SHEATH. THE INITIAL WIRE WAS MANIPULATED AND/OR REMOVED THROUGH THE ENTRY NEEDLE. WHEN ATTEMPTING TO REMOVE, THE PHYSICIAN FELT RESISTANCE AND SWITCHED TO ANOTHER MANUFACTURER'S GUIDEWIRE AND IT CAME LOOSE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14497796 ↗
• InjuryMay 7, 2022Break; Break

  AS REPORTED, DURING A CORONARY ANGIOGRAM VIA FEMORAL ACCESS, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S SHEATH SEPARATED UPON REMOVAL FROM THE PATIENT. THE FEMORAL ARTERIES WERE REPORTEDLY VERY CALCIFIED AND ACCESS WAS DESCRIBED AS DIFFICULT; HOWEVER, THE USER DENIED MEETING RESISTANCE UPON INSERTION OR REMOVAL OF THE DEVICE. THE GROIN WAS NOT SCARRED, AND THE SHEATH WAS NOT ADVANCED THROUGH A PREVIOUSLY-PLACED CLOSURE DEVICE. A WIRE WAS INSERTED THROUGH THE SHEATH AND AS THE USER ATTEMPTED TO REMOVE THE SHEATH OVER THE WIRE, HALF OF THE SHEATH SEPARATED IN THE FEMORAL ARTERY. VASCULAR PHYSICIANS WERE CONSULTED, AND A CUT-DOWN WAS PERFORMED UNDER GENERAL ANESTHESIA; HOWEVER, THE VESSELS WERE TOO CALCIFIED TO SAFELY CLAMP THE ARTERIES AND THE PROCEDURE WAS ABANDONED. LEFT FEMORAL ACCESS WAS THEN OBTAINED, AND A SNARE WAS USED TO REMOVE THE SEPARATED FRAGMENT UNDER RADIOLOGY GUIDANCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14316519 ↗
• MalfunctionMar 24, 2022Material Frayed; Difficult to Advance; Material Frayed; Difficult to Advance

  AS REPORTED, THERE HAVE BEEN 4-5 (LINKED FILES: 356997, 357321, AND 357322) ATTEMPTED USES OF MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SETS BY DIFFERENT SURGEONS, BUT THEY HAVE ALL BEEN DEFECTIVE. THE PROCEDURES WERE ENDOVENOUS LASER ABLATIONS. THE DEVICES WERE "FALLING APART" WHEN THE USER ATTEMPTED TO THREAD THEM. THE .018/40CM WIRE WAS FRAYING DURING ADVANCEMENT. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THE OCCURRENCE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13893072 ↗
• MalfunctionMar 24, 2022Material Frayed; Difficult to Advance; Material Frayed; Difficult to Advance

  AS REPORTED, THERE HAVE BEEN 4-5 (LINKED FILES: (B)(4)) ATTEMPTED USES OF MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SETS BY DIFFERENT SURGEONS, BUT THEY HAVE ALL BEEN DEFECTIVE. THE PROCEDURES WERE ENDOVENOUS LASER ABLATIONS. THE DEVICES WERE "FALLING APART" WHEN THE USER ATTEMPTED TO THREAD THEM. THE .018/40CM WIRE WAS FRAYING DURING ADVANCEMENT. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THE OCCURRENCE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13892926 ↗
• MalfunctionMar 24, 2022Material Frayed; Difficult to Advance; Material Frayed; Difficult to Advance

  AS REPORTED, THERE HAVE BEEN 4-5 (B)(4) ATTEMPTED USES OF MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SETS BY DIFFERENT SURGEONS, BUT THEY HAVE ALL BEEN DEFECTIVE. THE PROCEDURES WERE ENDOVENOUS LASER ABLATIONS. THE DEVICES WERE "FALLING APART" WHEN THE USER ATTEMPTED TO THREAD THEM. THE .018/40CM WIRE WAS FRAYING DURING ADVANCEMENT. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THE OCCURRENCE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13892923 ↗
• MalfunctionMar 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN INTERVENTIONAL PROCEDURE OF THE RIGHT SUPERFICIAL FEMORAL ARTERY, THE HUB SEPARATED FROM A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET¿S OUTER CATHETER/CANNULA. RESISTANCE WAS ENCOUNTERED UPON BOTH INSERTION AND REMOVAL OF THE DEVICE THROUGH THE LEFT COMMON FEMORAL ARTERY, AS THE ACCESS SITE WAS SCARRED DUE TO MULTIPLE PAST INTERVENTIONS. AN UNSPECIFIED COOK BENTSON WIRE WAS USED WITH THE DEVICE, WHICH DID NOT KINK. IT IS UNKNOWN IF THE COMPLAINT DEVICE WAS ADVANCED THROUGH ANY PREVIOUSLY PLACED CLOSURE DEVICES. UPON REMOVAL OF THE CATHETER/CANNULA FROM THE PATIENT, THE HUB SEPARATED. PER THE REPORTER, NO ADDITIONAL DEVICES WERE REQUIRED, AS THE DEVICE HAD SERVED ITS PURPOSE. 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 13859509 ↗
• InjuryMar 15, 2022Break; Break

  AS REPORTED, DURING AN IVC FILTER REMOVAL AND USING A MICROPUNCTURE TRANSITION LESS STIFFENED CANNULA ACCESS SET, THE INTRODUCER BROKE OFF INSIDE OF THE PATIENT. THE PHYSICIAN GAINED ACCESS THROUGH THE RIGHT GROIN, SNARED THE TIP OF THE WIRE, AND PULLED THE WIRE AND SNARE OUT OF THE RIGHT JUGULAR ACCESS. THERE WAS NO SCARRING OR CALCIFICATION NOTED AT THE ACCESS SITE. THERE WAS NO RESISTANCE NOTED DURING INSERTION OR REMOVAL OF ANY COMPONENTS. UPON REMOVAL OF THE INTRODUCER PART OF THE DEVICE BROKE OFF. THE PIECE THAT BROKE, THE DISTAL HALF OF THE INTRODUCER, CAME OUT AS IT WAS STUCK TO THE WIRE. THE PHYSICIAN MAINTAINED ACCESS, PULLED THE WIRE BACK DOWN AND FINISHED THE PROCEDURE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THE OCCURRENCE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13770178 ↗
• MalfunctionFeb 18, 2022Difficult to Remove; Unraveled Material; Difficult to Advance; Difficult to Remove; Unraveled Material; Difficult to Advance

  AS REPORTED, DURING A RIGHT LOWER EXTREMITY ANGIOPLASTY AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET WAS BEING USED. THE LEAD TECH GAINED ACCESS THROUGH THE FEMORAL ARTERY USING ULTRASOUND AND THE 21G 7CM MICROPUNCTURE NEEDLE AFTER FLUSHING WITH SALINE. THEY OBSERVED BLOOD RETURN THROUGH THE NEEDLE HUB, THEN THEY PROCEEDED TO INSERT THE NITINOL WIRE INCLUDED IN THE SET. UPON INSERTION, THE TECH NOTICED RESISTANCE. THEY MOVED THE WIRE GUIDE BACKWARD THROUGH THE NEEDLE AND ATTEMPTED TO ADVANCE AGAIN WHEN THE WIRE GUIDE GOT STUCK. IT WAS UNABLE TO BE PULLED BACK OR ADVANCED ANY FURTHER. THEY REMOVED THE NEEDLE AND THE WIRE GUIDE TOGETHER. A NEW SAME TYPE DEVICE WAS OPENED AND USED TO SUCCESSFULLY GAIN ACCESS AND ADVANCE THE WIRE FULLY INTO THE ARTERY. THE TECH NOTED THAT THE WIRE GUIDE TIP OF THE COMPLAINT DEVICE HAD COMPLETELY UNRAVELED. THERE WAS NO SCARRED TISSUE OR CALCIFICATION NOTE. THERE WAS NO KINKING OF THE DEVICE NOTED. NO SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THE OCCURRENCE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13560303 ↗
• MalfunctionMar 16, 2021Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11495961 ↗
• MalfunctionFeb 22, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

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

  MAUDE report 11362480 ↗
• InjuryFeb 15, 2021Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11327232 ↗
• MalfunctionFeb 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS PROVIDED ON 05APR2021: THE PROCEDURE BEING PERFORMED WAS A FISTULAGRAM IN THE RIGHT ARM. ADDITIONAL PATIENT OUTCOME INFORMATION WAS REQUESTED, BUT IT IS UNKNOWN. NO ADDITIONAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 11306914 ↗
• MalfunctionFeb 2, 2021Detachment of Device or Device Component; 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 11270022 ↗
• MalfunctionDec 16, 2020Material Separation; Material Separation

  AS REPORTED, DURING INTERVENTION OF THE SUPERFICIAL FEMORAL AND ANTERIOR TIBIAL ARTERIES USING A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET, THE HUB DISCONNECTED FROM THE BODY OF THE SHEATH. UPON ULTRASOUND GUIDED ANTEGRADE ACCESS OF THE COMMON FEMORAL ARTERY, THE USER NOTED HUB DISCONNECTION OCCURRED UPON REMOVAL OF THE SHEATH. THERE WAS RESISTANCE NOTED ON BOTH INSERTION AND REMOVAL. THE PATIENT HAD SOME SEVERE SCARRING.THE BODY PORTION OF THE SHEATH REMAINED HALF INSIDE OF THE ACCESS, AND IT WAS ABLE TO BE RETRIEVED WITH NO ISSUES. NO ADDITIONAL PROCEDURES WERE REQUIRED. NO ADVERSE EFFECTS WERE REPORTED DUE TO THIS OCCURRENCE.

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

  MAUDE report 11022843 ↗
• MalfunctionNov 25, 2020Material Separation; Material Separation

  ADDITIONAL INFORMATION AND CLARIFICATION RECEIVED ON 24NOV2020. THE DEVICE DID NOT SEPARATE. A BEND IN THE DEVICE WAS OBSERVED PRIOR TO CONTACT WITH THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10900427 ↗
• MalfunctionAug 26, 2020Material Separation; Stretched; Material Separation; Stretched

  ADDITIONAL INFORMATION WAS RECEIVED. THE ACCESS SITE WAS NOT BELIEVED TO BE CALCIFIED OR SCARRED "BEYOND ANYTHING NORMAL".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10454814 ↗