AngioJet™ ZelanteDVT™ 114610-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 08714729904724), received between Jun 20, 2018 and May 21, 2026 — classified as 7 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WENT INTO RENAL FAILURE POST-PROCEDURE AND HAD TO BE TAKEN TO THE HOSPITAL. AN ANGIOJET ZELANTEDVT WAS SELECTED FOR USE IN A THROMBECTOMY PROCEDURE. THE DEVICE WAS SUCCESSFULLY USED DURING THE PROCEDURE WITHOUT ANY COMPLICATIONS. POST PROCEDURE, IT WAS NOTED THAT THE PATIENT'S CREATININE LEVEL WHICH WAS HIGHLY ELEVATED AND WENT INTO RENAL FAILURE. THE PATIENT WAS TAKEN TO THE HOSPITAL FOR FURTHER TREATMENT AND EVALUATION.

  Patient problems: Renal Failure

  MAUDE report 25243055 ↗
• MalfunctionMar 11, 2025Break; Break

  IT WAS REPORTED THAT TIP BREAK OCCURRED. THE ANGIOJET ZELANTEDVT WAS SELECTED FOR USE DURING THE PROCEDURE. THE PHYSICIAN PERFORMED A THROMBECTOMY USING A 12 FR SHEATH, WITH THE SMART CLAW CATHETER ADVANCED OVER A 0.35 GLIDE WIRE AND THE ZELANTE CATHETER ADVANCED OVER A SECOND 0.35 GLIDE WIRE. THE SMARTCLAW THROMBECTOMY WAS PERFORMED ACCORDING TO PROTOCOL. THE ZELANTE CATHETER WAS REMOVED FIRST, FOLLOWED BY THE SMARTCLAW. RESISTANCE WAS ENCOUNTERED DURING THE REMOVAL OF THE ZELANTE CATHETER, AND UPON INSPECTION, IT WAS NOTED THAT THE CATHETER TIP WAS BROKEN, WITH THE DISTAL MARKER AND TIP DETACHED. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE BROKEN FRAGMENT AND PERFORMED AN ANGIOGRAM TO CONFIRM NO RESIDUAL PIECES REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT REMAINED IN GOOD CONDITION POST-PROCEDURE. IT WAS FURTHER REPORTED THAT THE DEVICE BROKE AT THE DISTAL TIP, SPECIFICALLY AT THE DISTAL MARKER BAND, WHILE INSIDE THE PATIENT. NO ERROR MESSAGE APPEARED DURING THE PROCEDURE, AND THE DEVICE AND PACKAGING WERE INSPECTED BEFORE USE WITHOUT ANY VISIBLE DAMAGE. THE THROMBECTOMY THERAPY WAS ABORTED, AND A C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574929 ↗
• InjuryFeb 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE, A RARE CASE ACUTE PANCREATITIS FOLLOWING PERCUTANEOUS MECHANICAL THROMBECTOMY OF LEFT COMMON ILIAC VEIN. THIS ANGIOJET ZELANTE DVT CLOTHUNTER WAS CHOSEN AS TREATMENT FOR LEFT COMMON ILIAC VEIN BALLOON VENOPLASTY WITH DENALI IVC FILTER INSERTION FOR PULMONARY EMBOLISM PREVENTION. THE PATIENT TOLERATED THE PROCEDURE WITHOUT IMMEDIATE COMPLICATION AND WAS DISCHARGED HOME. UNFORTUNATELY, OVER THE COURSE OF THE EVENING THE PATIENT DEVELOPED ACUTE ONSET UPPER ABDOMINAL DISCOMFORT THAT RADIATED TO HER BACK. THE SYMPTOMS WERE ASSOCIATED WITH SEVERE NAUSEA, MULTIPLE EPISODES OF BLOODY NON-BILIOUS VOMITING AND DARK COLA-COLORED URINE. ON PRESENTATION, THE PATIENT WAS HEMODYNAMICALLY STABLE. PHYSICAL EXAMINATION WAS NOTABLE FOR A SOFT AND NON-DISTENDED ABDOMEN WITH ACTIVE BOWEL SOUNDS, BUT DIFFUSE TENDERNESS TO PALPATION, MOST PRONOUNCED IN RIGHT UPPER QUADRANT, WITHOUT PERITONEAL SIGNS. INITIAL LABORATORY ANALYSIS REVEALED AN ELEVATED WHITE BLOOD CELL COUNT (18.9 K/UL), BLOOD UREA NITROGEN (34 MG/DL), CREATININE (1.80 MG/DL), HIGH-SENSITIVITY TROPONIN (11,711 NG/L), LACTIC ACID (5.6 MMOL/L), AND LIPASE (1538 UNITS/L). LIPID PANEL WAS OBTAINED FOR RULE OUT

  Patient problems: Abdominal Pain; Anemia; Hematuria; Hemorrhage/Blood Loss/Bleeding; High White Blood Cell Count; Nausea; Pancreatitis; Vomiting

  MAUDE report 18676189 ↗
• MalfunctionDec 15, 2023Break; Break

  IT WAS REPORTED THAT A CATHETER BREAK OCCURRED. A ZELANTE DVT CLOT HUNTER WAS ADVANCED FOR THROMBECTOMY PROCEDURE. UPON OPENING THE PACKAGING, IT WAS NOTED THAT A PIECE OF THE CATHETER BROKE OFF. THE DEVICE WAS NOT USED, AND THE PROCEDURE WAS CANCELLED. THE PATIENT WAS UNDER LOCAL ANESTHESIA. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18335888 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL PERFORATION OCCURRED. AN ANGIOJET ZELANTE WAS USED DURING THE THROMBECTOMY PROCEDURE. HOWEVER, THE VENOGRAM ACQUIRED AFTER THE POWER PULSE AND THROMBECTOMY REVEALED A SPOT WITH CONTRAST OUTSIDE OF THE VESSEL THAT LOOKS TO BE A VASCULAR PERFORATION. A POWER PULSE TRIGGERED THE PATIENT'S VASCULAR PERFORATION. BRIDGED THE LESION WITH LITTLE DIFFICULTY, AND PRE-TREATMENT VENOGRAM AND IVUS REVEALED NO INDICATION OF A PROBLEM. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Perforation of Vessels

  MAUDE report 15674445 ↗
• MalfunctionOct 4, 2021Contamination; Unsealed Device Packaging; Contamination; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PACKAGING SEAL WAS COMPROMISED. AN ANGIOJET ZELANTEDVT CATHETER WAS OPENED FOR PROCEDURE. HOWEVER, IT WAS NOTICED THAT THERE IS A SMALL CUT ON STERILE PACKAGE AND THE INNER PACKAGE HAD BEEN COMPROMISED AFTER OPENING THE BOX. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569734 ↗
• MalfunctionSep 21, 2021Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01-SEPTEMBER-2021. IT WAS REPORTED THAT THE DEVICE WOULD NOT ENTER SHEATH OCCURRED. AN ANGIOJET ZELANTEDVT CATHETER WAS USED FOR THROMBECTOMY PROCEDURE. HOWEVER, DURING THE INSERTION OF DEVICE, THE DEVICE WOULD NOT ENTER THE SHEATH WHEN LOADED ON THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A FOREIGN MATERIAL ON THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12508576 ↗
• MalfunctionAug 4, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER STUCK ON WIRE OCCURRED. AN ANGIOJET ZELANTEDVT CATHETER WAS USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, DESPITE RE-PRIMING AND FLUSHING, IT WAS NOTED THAT THE GUIDEWIRE WAS STUCK ON THE CATHETER. BOTH DEVICES WERE REMOVED TOGETHER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12275147 ↗
• MalfunctionMay 28, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER STUCK ON GUIDEWIRE OCCURRED. AN ANGIOJET ZELANTEDVT CATHETER WAS USED IN A THROMBECTOMY PROCEDURE. DURING WITHDRAWAL, THE DEVICE WAS STUCK WITH A NON-BSC WIRE. THE DEVICES WERE REMOVED FROM THE PATIENT'S BODY TOGETHER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11902100 ↗
• MalfunctionMay 11, 2021Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT A CATHETER BREAK OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON-CALCIFIED SUBCLAVIAN VEIN. AN ANGIOJET ZELANTEDVT WAS ADVANCED FOR THROMBECTOMY PROCEDURE. UPON ADVANCING TOWARDS THE LESION, RESISTANCE WAS MET. THE PHYSICIAN STOPPED ADVANCING AND PULLED THE CATHETER BACK FOR APPROXIMATELY 1CM AND ATTEMPTED TO ADVANCE AGAIN, BUT MET SOME RESISTANCE AGAIN. WHEN THE PHYSICIAN REMOVED THE CATHETER, A FRACTURE ON THE DEVICE WAS NOTED. THE CATHETER WAS REMOVED INTACT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809937 ↗
• MalfunctionMay 6, 2021Entrapment of Device; Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Mechanical Jam; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED. AN ANGIOJET ZELANTEDVT WAS USED FOR A THROMBECTOMY PROCEDURE. DURING PROCEDURE, IT WAS NOTED THAT THE CATHETER WOULD NOT TRACK OVER THE WIRE CORRECTLY AND ENDED UP GETTING STUCK. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11783505 ↗
• MalfunctionMar 18, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE LEFT FEMORAL VEIN. AN ANGIOJET ZELANTEDVT CATHETER WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, IT WAS NOTED THAT CHECK SALINE SUPPLY ERROR OCCURRED. THERE WAS NO OTHER AVAILABLE CATHETER SO THE PROCEDURE WAS ABANDONED. THE PROCEDURE WAS CONTINUED THE FOLLOWING DAY. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516845 ↗
• MalfunctionFeb 10, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER STUCK ON GUIDEWIRE OCCURRED. AN ANGIOJET ZELANTEDVT CATHETER WAS USED FOR A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER FROZE ON A NON-BSC HYDROPHILIC WIRE AND WAS UNABLE TO SEPARATE. THE DEVICES AND THE SHEATH WERE SIMPLY REMOVED FROM THE PATIENT'S BODY AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS OR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11308232 ↗
• MalfunctionFeb 10, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER STUCK ON GUIDEWIRE OCCURRED. AN ANGIOJET ZELANTEDVT WAS USED FOR A THROMBECTOMY PROCEDURE. HOWEVER, IT WAS NOTED THAT THE CATHETER WOULD NOT MOVE BACK AND FORTH OVER THE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11308106 ↗
• MalfunctionFeb 1, 2021Suction Problem; Suction Problem

  IT WAS REPORTED THAT LOSS OF ASPIRATION OCCURRED. AN ANGIOJET ZELANTEDVT CATHETER WAS USED FOR A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER STOPPED ASPIRATING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11260845 ↗
• MalfunctionNov 24, 2020Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02-NOVEMBER-2020. IT WAS REPORTED THAT THE PUMP BOOT WAS LEAKING. AN ANGIOJET ZELANTEDVT CATHETER WAS USED IN A THROMBECTOMY PROCEDURE. DURING PREPARATION, IT WAS NOTED THAT THE CATHETER WAS LEAKING AT THE BULB. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10891005 ↗
• MalfunctionNov 9, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER STUCK ON GUIDEWIRE OCCURRED. AN ANGIOJET ZELANTEDVT CATHETER WAS USED FOR A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS STUCK ON WIRE. THE WIRE WAS CHANGED BUT SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10810264 ↗
• InjuryJul 2, 2020Entrapment of Device; Detachment of Device or Device Component; Difficult to Advance; Material Deformation; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Detachment of Device or Device Component; Difficult to Advance; Material Deformation; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TIP OF THE DEVICE DETACHED INSIDE THE PATIENT, REQUIRING ADDITIONAL INTERVENTION. AN ANGIOJET ZELANTEDVT CATHETER WAS SELECTED FOR A THROMBECTOMY PROCEDURE. FROM A POPLITEAL ACCESS SITE, THE OCCLUSION AND TWO PREVIOUSLY PLACED 12X120 AND 12X60 VICI ILIAC STENTS WERE CROSSED WITH A STIFF NON-BSC GUIDEWIRE AND A NON-BSC ANGIOGRAPHIC CATHETER. THE SHEATH WAS EXCHANGED FOR AN 8F X 10CM SIZE, AND THE GUIDEWIRE WAS EXCHANGED FOR A 0.035" AMPLATZ GUIDEWIRE. THE ANGIOJET ZELANTEDVT CATHETER WAS PRIMED WITH NO ISSUES AND WAS LOADED THROUGH THE SHEATH OVER THE AMPLATZ GUIDEWIRE. WHILE TRACKING THE CATHETER, RESISTANCE WAS NOTED, AND AT SOME POINT, COULD NO LONGER ADVANCE OR RETRACT THE CATHETER OR GUIDEWIRE. AFTER MUCH MANIPULATION OF THE CATHETER, THE PHYSICIAN FELT SOMETHING DISLODGE WHILE CONTINUING TO PULL BACK ON THE PROXIMAL END OF THE DEVICE. EVENTUALLY A PARTIALLY INTACT CATHETER WAS ABLE TO BE WITHDRAWN; THIS INCLUDED THE OUTER METAL SHAFT AND THE ENTIRE HYPOTUBE, WHICH WAS IDENTIFIABLE BY THE RADIOPAQUE MARKER THAT FALLS BETWEEN THE TWO CATHETER RADIOPAQUE MARKERS. THE CATHETER WAS STUCK ON THE GUIDEWIRE, AND THE TIP WAS STILL LODGED IN THE VESSEL AS IDENTI

  Patient problems: No Code Available

  MAUDE report 10224183 ↗
• MalfunctionJul 1, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT CATHETER BECAME STUCK ON THE GUIDEWIRE AND BROKE. THE TARGET LESION WAS LOCATED IN THE LEFT ILIAC ARTERY. AN ANGIOJET ZELANTEDVT WAS USED FOR A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CATHETER BECAME STUCK ON THE NON-BSC GUIDEWIRE AND BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10219296 ↗
• MalfunctionApr 28, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22-APRIL-2020. IT WAS REPORTED THAT AN ERROR MESSAGE WAS DISPLAYED. AN ANGIOJET ZELANTEDVT WAS USED FOR A THROMBECTOMY PROCEDURE IN THE LEFT LEG. DURING START OF PROCEDURE WHILE PUTTING IN THE TISSUE PLASMINOGEN ACTIVATOR (TPA), MULTIPLE ERRORS REQUESTING ALARM TO BE RESET OCCURRED IN POWER PULSE MODE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. HOWEVER, DEVICE ANALYSIS REVEALED A HYPOTUBE BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10004611 ↗
• MalfunctionMar 20, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2020. IT WAS REPORTED THAT THE CATHETER WAS UNABLE TO PRIME. AN ANGIOJET ZELANTED VT CATHETER WAS SELECTED FOR A DEEP VENOUS THROMBOSIS PROCEDURE. THE CATHETER WOULD NOT PRIME PROPERLY AND IT DID NOT ENTERED THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A PLUGGED JET HOLE.

  Patient problems: No Patient Involvement

  MAUDE report 9860641 ↗
• MalfunctionMar 13, 2020Defective Device

  ELDERLY FEMALE WITH HISTORY OF HYPERTENSION AND TYPE 2 DIABETES. LEFT LEG PAIN FOR 2 DAYS, POSITIVE DEEP VEIN THROMBOSIS. UNDERGOING LEFT LOWER EXTREMITY PERCUTANEOUS THROMBECTOMY WITH ANGIOJET AND GENIOPLASTY. DURING THE PROCEDURE, THE ANGIOJET WAS SUCKING INSTEAD OF SPRAYING TPA ON THE APPROPRIATE SETTING. DEVICE REMOVED WITHOUT HARM TO THE PATIENT.

  Patient problems: Pain; Thrombosis

  MAUDE report 9828881 ↗
• MalfunctionMar 4, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER STUCK ON GUIDEWIRE OCCURRED. AN ANGIOJET ZELANTEDVT CATHETER WAS SELECTED FOR USE IN A THROMBECTOMY PROCEDURE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER BECAME STUCK ON THE UNKNOWN WIRE. THE CATHETER WAS REMOVED FROM THE PATIENT'S BODY ALONG WITH THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9787872 ↗
• MalfunctionFeb 24, 2020Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER WAS STUCK ON THE GUIDEWIRE AND CATHETER DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER EXTREMITY. AN ANGIOJET ZELANTEDVT WAS ADVANCED FOR A THROMBECTOMY PROCEDURE. DURING PROCEDURE, THE PHYSICIAN TRIED TO REMOVE THE CATHETER OFF A 0.35 X 260CM NON-BSC GUIDEWIRE. HOWEVER, THE CATHETER BECAME STUCK ON THE WIRE. AFTER TRYING TO REMOVE THE CATHETER OVER THE WIRE, IT SNAPPED INTO HALF OUTSIDE THE PATIENT'S BODY. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY WITHOUT ANY FRAGMENTS LEFT INSIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9744757 ↗
• MalfunctionFeb 7, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT AND TIP DETACHMENT OCCURRED. AFTER AN AMPLATZ GUIDEWIRE WAS INSERTED, AN ANGIOJET ZELANTEDVT WAS ADVANCED FOR A THROMBECTOMY PROCEDURE IN THE LEFT COMMON FEMORAL, EXTERNAL ILIAC, AND LEFT COMMON ILIAC VEINS. HOWEVER, DURING PROCEDURE, THE CATHETER TIP BECAME STUCK ON THE GUIDEWIRE AND THE CATHETER TIP BROKE. THE DEVICE SHREDDED WHEN GOING OVER THE WIRE INSIDE THE SHEATH. THE CATHETER AND GUIDEWIRE HAD TO BE REMOVED TOGETHER. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE AND RECOVERING FROM THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9681847 ↗