Visions PV .018 Digital IVUS Catheter 86700Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00184360000037), received between Jan 12, 2017 and Jan 7, 2026 — classified as 24 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Material Separation” (53 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 13, 2025Class IIOpen, Classified

   Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further intervention, such as surgical removal; Firm is restating instructions for use and adding: "Use a guide sheath of appropriate length to provide adequate support to the rapid exchange IVUS catheter and guidewire"

   Z-2221-2025 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Material Separation

  IT WAS REPORTED THAT A VISIONS PV .018 CATHETER WAS USED IN A DIAGNOSTIC PROCEDURE. DURING USE, A WEIRD PICTURE WAS DISPLAYED, MAKING THE DECISION TO SWAP FOR ANOTHER CATHETER. HOWEVER, UPON REMOVAL, IT WAS OBSERVED THAT THE TIP SEPARATED. A NEW VISIONS CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO ADDITIONAL INTERVENTION. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS CATHETER TIP SEPARATED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23997752 ↗
• MalfunctionDec 16, 2025Image Orientation Incorrect; Device Dislodged or Dislocated

  THE IVUS WAS DISPLAYING A WEIRD PICTURE THE FIRST TIME BEING USED IN THIS CASE. THE DOCTOR DECIDED TO SWAP IT OUT FOR ANOTHER 0.018 IVUS. WHEN THE IVUS WAS TAKEN OUT OF THE PATIENT THE TIP DISLODGED COMPLETELY FROM THE REST OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815579 ↗
• MalfunctionJul 3, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A VISIONS CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. DURING REMOVAL, THE NON-PHILIPS GUIDEWIRE'S HYDROPHILIC COATING WAS BEING STRIPPED BY THE CATHETER; THUS, BOTH WERE REMOVED AS A SYSTEM TO PREVENT THE COATING BEING LEFT IN THE PATIENT. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS CATHETER AND GUIDEWIRE WERE REMOVED AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22401085 ↗
• MalfunctionJun 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS PV .018 CATHETER WAS USED IN A PERIPHERAL THERAPEUTIC PROCEDURE IN THE MID SFA. AFTER THE FIRST RUN, A CATHETER FAULT WAS DETECTED. THE PROCEDURE WAS COMPLETED WITH A NEW CATHETER. NO PATIENT INJURY REPORTED. DURING THE DEVICE EVALUATION, MISSING MATERIAL FROM THE EXPANDED SINGLE LUMEN (ESL) TUBING WAS OBSERVED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO MISSING MATERIAL. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337056 ↗
• MalfunctionJun 20, 2025Output Problem

  WHEN THE IVUS [INTRAVASCULAR ULTRASOUND] WAS LOADED ONTO THE WIRE AND PLACED INTO THE PATIENT VESSEL, IT WAS THEN PLUGGED INTO THE POWER SOURCE. THE CATHETER WOULD NOT WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296829 ↗
• InjuryMay 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE TO TREAT A SEVERELY CALCIFIED DISTAL POPLITEAL. DURING REMOVAL, THE CATHETER TIP GOT CAUGHT ON AN ILIAC STENT AND BROKE OFF INSIDE THE PATIENT. ATTEMPTS TO RETRIEVE THE TIP WITH A SNARE WAS UNSUCCESSFUL; THEREFORE, THE PATIENT WAS REFERRED TO SURGERY. HOWEVER, DUE TO THE LOCATION WHERE THE TIP GOT DISLODGED AND UNABLE TO TRAVEL OR EMBOLIZE, THE TIP WAS RETAINED IN THE PATIENT. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS CATHETER TIP SEPARATED INSIDE THE PATIENT, REQUIRING INTERVENTION, BUT RETAINED IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22092686 ↗
• MalfunctionMay 5, 2025Connection Problem

  UPON CONNECTION TO IVUS [INTRAVASCULAR ULTRASOUND] MACHINE, MACHINE READ UNABLE TO CONNECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960724 ↗
• MalfunctionMay 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS PV .018 CATHETER WAS USED IN A PERIPHERAL DIAGNOSTIC PROCEDURE IN A MODERATELY CALCIFIED PROXIMAL ILIAC ARTERY. DURING REMOVAL, THE CATHETER GOT STUCK ON THE NON-PHILIPS GUIDEWIRE, AND APPROX. 6" OF THE DISTAL PORTION HAD SEPARATED, BUT REMAINED INTACT TO THE GUIDEWIRE. BOTH WERE REMOVED AS A SYSTEM, AND IMAGING CONFIRMED NOTHING WAS LEFT IN THE PATIENT. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS CATHETER SHAFT SEPARATED; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953027 ↗
• MalfunctionApr 29, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT A VISIONS PV .018P CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. DURING REMOVAL, THE CATHETER BECAME KINKED, AND THE ENTIRE SYSTEM WAS REMOVED AS A UNIT. THE PROCEDURE WAS COMPLETED WITHOUT USING IVUS. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS CATHETER AND CONCOMITANT DEVICES WERE REMOVED AS A SYSTEM; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930207 ↗
• MalfunctionFeb 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS PV .018 CATHETER WAS USED IN A PERIPHERAL THERAPEUTIC PROCEDURE. DURING REMOVAL, WHILE PASSING THROUGH THE INTRODUCER SHEATH, THE CATHETER DISTAL TIP SEPARATED. BOTH THE CATHETER WITH THE DISTAL TIP AND SHEATH WERE REMOVED AS A SYSTEM. THE PROCEDURE WAS COMPLETED WITH THE VISIONS CATHETER. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS DISTAL TIP SEPARATED; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21317674 ↗
• MalfunctionDec 3, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS PV .018 CATHETER WAS USED IN A PERIPHERAL THERAPEUTIC PROCEDURE IN A MODERATELY CALCIFIED RIGHT COMMON ILIAC. DURING USE, THE CATHETER GOT STUCK ON THE GUIDEWIRE AND THE TIP SEPARATED WITHIN THE INTRODUCER SHEATH. THE SEPARATED TIP AND THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT. THE SEPARATED TIP MEASURED APPROX. 5 MM IN LENGTH. NO PATIENT INJURY WAS REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS TIP SEPARATED INSIDE THE PATIENT; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833236 ↗
• MalfunctionNov 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS PV .018 CATHETER WAS USED IN A DIAGNOSTIC PERIPHERAL PROCEDURE IN A MODERATELY CALCIFIED PROXIMAL SFA. DURING REMOVAL FROM THE PATIENT, THE DISTAL TIP SEPARATED FROM THE TRANSDUCER AND GOT STUCK INSIDE THE NON-PHILIPS INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS DISTAL TIP SEPARATED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20691962 ↗
• MalfunctionNov 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS PV .018 CATHETER WAS USED IN AN EMERGENT PERIPHERAL PROCEDURE. DURING PREP, WHILE LOADING THE CATHETER OVER THE GUIDEWIRE, THE TIP SEPARATED OUTSIDE THE PATIENT. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE CATHETER COULD NOT BE USED DURING AN EMERGENT CASE, RESULTING IN A POTENTIAL FOR HARM DUE TO THE DELAY OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20637934 ↗
• InjuryOct 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS CATHETER WAS USED IN A PERIPHERAL THERAPEUTIC PROCEDURE. DURING USE, THE TIP SEPARATED INSIDE THE PATIENT. A SNARE WAS USED TO RETRIEVE THE SEPARATED TIP. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS CATHETER TIP SEPARATED INSIDE THE PATIENT, REQUIRING ADDITIONAL INTERVENTION FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20539860 ↗
• MalfunctionJun 28, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS PV .018 CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE IN A MODERATELY CALCIFIED LESION. DURING RETRACTION, THE DISTAL TIP SEPARATED INSIDE THE PATIENT. UPON REMOVAL, APPROXIMATELY 1 INCH OF THE DISTAL TIP SEPARATED BUT REMAINED INTACT TO THE GUIDEWIRE. ALL PIECES OF THE CATHETER WERE REMOVED FROM THE PATIENT SUCCESSFULLY. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS CATHETER DISTAL TIP SEPARATED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19639392 ↗
• MalfunctionApr 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS PV .018 CATHETER WAS USED IN A DIAGNOSTIC PERIPHERAL PROCEDURE IN A CALCIFIED DISTAL AT. WHILE PASSING THROUGH THE LESION, THE DISTAL TIP SEPARATED BUT REMAINED INTACT TO THE NON-PHILIPS GUIDEWIRE. ALL PARTS WERE REMOVED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS DISTAL TIP SEPARATED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19159431 ↗
• MalfunctionMar 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS PV .018 CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE IN A SLIGHTLY CALCIFIED DISTAL ILIAC ARTERY. DURING REMOVAL, THE DISTAL TIP SEPARATED BUT REMAINED INTACT TO THE NON-PHILIPS GUIDEWIRE AND WAS STUCK AT THE HEMOSTATIC VALVE OF THE SHEATH. ANGIO CONFIRMED NO PIECE OF THE CATHETER WAS RETAINED IN THE PATIENT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS DISTAL TIP SEPARATED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899760 ↗
• InjuryOct 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS PV .018 CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE IN THE PROXIMAL BRACHIAL ARTERY. DURING REMOVAL, THE CATHETER DISTAL TIP SEPARATED IN THE LEFT BASILIC VEIN OF THE FISTULA AND REQUIRED REMOVAL WITH A SNARE. THERE WAS NO RESISTANCE OR FORCE APPLIED DURING PULLBACK, AND NO CALCIFICATION OR SCAR TISSUE NOTED IN THIS AREA. X-RAY CONFIRMED NO PIECE WAS RETAINED INSIDE THE PATIENT. THE PATIENT WAS DISCHARGED AFTER POST CARE WITH NO INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE TIP SEPARATION REQUIRING INTERVENTION (SNARE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17881012 ↗
• InjuryJul 13, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS CATHETER WAS USED IN A PERIPHERAL THERAPEUTIC PROCEDURE VIA LEFT ARM RADIAL ARTERY ACCESS. THE CATHETER WAS LOADED OVER A 0.018 GUIDEWIRE VIA SHEATH AND WAS ABLE TO ADVANCE, BUT COULD NOT REACH DUE TO THE DISTANCE FROM THE ACCESS SITE TO THE TARGET VESSEL. DURING REMOVAL, RESISTANCE WAS NOTED DUE TO THE GUIDE WIRE WRAPPED AROUND THE CATHETER; THEREFORE, THE CATHETER AND GUIDE WIRE WERE REMOVED TOGETHER. UPON REMOVAL IT WAS OBSERVED THAT THE CATHETER TIP WAS MISSING. FLUOROSCOPIC IMAGES CONFIRMED THE TIP WAS LOCATED INSIDE THE PATIENTS LEFT DISTAL RADIAL ARTERY. A SNARE WAS DEPLOYED, ALONG WITH A SURGICAL CUTDOWN APPROACH TO RETRIEVE THE MISSING TIP SUCCESSFULLY. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS CATHETER TIP SEPARATED INSIDE THE PATIENT, REQUIRING ADDITIONAL INTERVENTION FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321639 ↗
• MalfunctionJun 26, 2023Break

  IVUS CATHETER TIP BROKE OFF IN PATIENT¿S LEFT ARM, REQUIRING CUT-DOWN TO RETRIEVE. WE ATTEMPTED TO ADVANCE AN IVUS CATHETER OVER THE WIRE, BUT WIRE WRAP OCCURRED, AND THE CATHETER WAS UNABLE TO BE WITHDRAWN FROM SHEATH AND CAUGHT WITHIN THE SOFT TISSUE OF THE PERCUTANEOUS ACCESS. MANUFACTURER RESPONSE FOR VOLCANO VISIONS PV.018 DIGITAL IVUS CATHETER, (BRAND NOT PROVIDED) (PER SITE REPORTER). CUSTOMER SERVICE WAS CONTACTED, AND EVENT FILED. REQUESTED PICTURES INSTEAD OF RETURNING DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17197515 ↗
• InjuryMar 10, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS PV .018 CATHETER WAS USED IN A FISTULAGRAM PROCEDURE. WHEN THE CATHETER WAS REMOVED FROM THE PATIENT, A MISSING DISTAL TIP WAS NOTED. FLUOROSCOPY IDENTIFIED THE DISTAL TIP WAS STILL OVER THE WIRE INSIDE THE PATIENT¿S MID-UPPER ARM LEVEL. THE WIRE WAS GENTLY RETRACTED WITH THE DISTAL TIP INTO THE SHEATH. COMPRESSION WAS APPLIED FOR HEMOSTASIS ON THE FISTULA AND AN INCISION WAS MADE AT THE LEVEL OF THE SHEATH. THE SHEATH WAS REMOVED AND THE DISTAL TIP WAS FISHED OUT USING SURGICAL INSTRUMENTS. THE INCISION WAS CLOSED AFTER ALL MATERIALS WERE REMOVED. FLUOROSCOPY CONFIRMED NO PIECE WAS RETAINED INSIDE THE PATIENT. THE PATIENT WAS DISCHARGED AS EXPECTED WITH NO INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE TIP SEPARATION REQUIRING SURGICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526490 ↗
• MalfunctionNov 18, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS PV .018 CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. DURING REMOVAL, IT WAS NOTICED THAT THE DISTAL TIP BROKE OFF WITHIN THE NON-PHILIPS INTRODUCER SHEATH, BUT ABLE TO BE REMOVED ALONG WITH A NON-PHILIPS GUIDE WIRE. X-RAY CONFIRMED NOTHING WAS LEFT IN PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. THE PATIENT WAS DISCHARGED AS EXPECTED, WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE DISTAL TIP SEPARATED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15823254 ↗
• InjuryAug 18, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A DIAGNOSTIC PERIPHERAL PROCEDURE, THE VISIONS PV .018 CATHETER WORKED PERFECTLY. DURING REMOVAL, THE DISTAL TIP SEPARATED NEAR THE PUNCTURE SITE. THE PATIENT WAS SEDATED WITH LOCAL ANESTHESIA AND A ONE (1) CM INCISION WAS MADE IN THE RIGHT ARM. DISSECTION BY PLANES WERE PERFORMED TO EXPLORE THE RIGHT BASILICA VEIN, AND WAS ABLE TO RETRIEVE THE DISTAL TIP. IMAGES CONFIRMED NO PIECE WAS RETAINED INSIDE THE PATIENT. THE PATIENT WAS DISCHARGED THE SAME DAY AS EXPECTED WITH NO INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE TIP SEPARATION REQUIRING SURGICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254771 ↗
• MalfunctionJul 8, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A DIAGNOSTIC PERIPHERAL PROCEDURE IN A SLIGHTLY CALCIFIED PROXIMAL SFA, WHILE REMOVING THE VISIONS PV.018 CATHETER, THE DISTAL TIP SEPARATED AND WAS STUCK ON THE NON-MANUFACTURER''S GUIDEWIRE. THE CATHETER AND GUIDEWIRE WERE REMOVED AS A UNIT WITH NO ADDITIONAL INTERVENTION PERFORMED. NO PIECE OF THE CATHETER WAS RETAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SUSPECT DEVICE WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS DISTAL TIP SEPARATED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14957871 ↗
• InjuryJun 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A THERAPEUTIC PERIPHERAL PROCEDURE, THE VISIONS PV .018 CATHETER DISTAL TIP SEPARATED WHILE IT WAS BEING RETRACTED FROM THE EXTERNAL LEFT COMMON ILIAC ARTERY. THE SEPARATED TIP WAS REMOVED WITH A SNARE AND THE PROCEDURE WAS COMPLETED WITH A NON-MANUFACTURER BALLOON-EXPANDABLE STENT SYSTEM. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO PATIENT INJURY REPORTED. THE PATIENT WAS TRANSFERRED TO PACU FOR MONITORING. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE TIP SEPARATION REQUIRING INTERVENTION (SNARE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14709396 ↗