Smart Coil 400SMTXSFT3H08Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00814548017129), received between Sep 27, 2016 and Aug 2, 2021 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (12 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TEN SMART COILS WERE SUCCESSFULLY IMPLANTED INTO THE TARGET LOCATION. WHILE ADVANCING THE NEXT SMART COIL, THE COIL WAS STUCK IN ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. IT WAS REPORTED THAT THE SMART COIL WAS PROPERLY ALIGNED TO THE MICROCATHETER; HOWEVER, THE SMART COIL FAILED TO ADVANCE AFTER SEVERAL ATTEMPTS. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL OF THE SAME SIZE WITH FIVE ADDITIONAL SMART COILS, FOUR NON-PENUMBRA COILS, AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259925 ↗
• MalfunctionApr 6, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA MICROCATHETERS, AND A NON-PENUMBRA PARENT CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED SIX SMART COILS AND THREE NON-PENUMBRA COILS INTO THE TARGET LOCATION. AFTER ALIGNING THE NEXT SMART COIL INTRODUCER SHEATH INSIDE THE HUB OF THE MICROCATHETER, THE PHYSICIAN ATTEMPTED TO ADVANCE THE SMART COIL; HOWEVER, THE SMART COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL, TWO OTHER COILS AND THE SAME MICROCATHETERS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617471 ↗
• MalfunctionMar 11, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE OUT OF THE OUTER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11463090 ↗
• MalfunctionOct 21, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN REPORTED TWO SMART COILS WOULD NOT DEPLOY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 10712687 ↗
• MalfunctionJul 24, 2020Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A SMART COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE SMART COIL INTO THE TARGET VESSEL AND SUBSEQUENTLY, THE SMART COIL BECAME STUCK AT THE END OF THE PLACEMENT. THEREFORE, THE PHYSICIAN DECIDED TO REPOSITION THE SMART COIL. WHILE REPOSITIONING THE SMART COIL, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE SMART COIL LOOKED THINNER WITHIN THE COIL BODY. THE SMART COIL STRETCHED AND WAS JUST CONNECTED THROUGH THE INNER WIRE. THEREFORE, THE PHYSICIAN REMOVED THE SMART COIL BY CAREFULLY PULLING BACK THE PUSHER ASSEMBLY. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10321012 ↗
• MalfunctionJun 12, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PERICALLOSAL ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10148901 ↗
• MalfunctionAug 22, 2019Failure to Fold; Material Too Rigid or Stiff; Failure to Fold; Material Too Rigid or Stiff

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL INTO THE ANEURYSM BUT REPORTED THAT THE LAST 1 CM OF THE SMART COIL WAS "SUPER STIFF" AND KEPT KICKING HIM OUT OF THE ANEURYSM. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO IMPLANT THE COIL, THE PHYSICIAN DECIDED TO RETRACT THE SMART COIL OUT OF THE PATIENT. THEREFORE, THE SMART COIL WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8923376 ↗
• MalfunctionJul 3, 2019Device Damaged Prior to Use; Physical Resistance/Sticking; Device Damaged Prior to Use; Physical Resistance/Sticking

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN NOTICED THAT A PENUMBRA SMART COIL (SMART COIL) WOULD NOT ADVANCE THROUGH AND EXIT OUT OF ITS INTRODUCER SHEATH. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO ADVANCE THE SMART COIL INTO A BOWL OF SALINE BUT THE SMART COIL WAS STUCK IN ITS INTRODUCER SHEATH. THE ISSUE WITH THE SMART COIL OCCURRED PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL.

  Patient problems: No Patient Involvement

  MAUDE report 8758358 ↗
• MalfunctionJun 17, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED FOUR SMART COILS AND OTHER COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW SMART COIL, THE PHYSICIAN NOTICED THE PUSHER ASSEMBLY WAS STUCK IN THE FRICTION LOCK AND THE SMART COIL WAS UNABLE TO ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS, OTHER COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8703814 ↗
• MalfunctionMay 9, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A SMART COIL PAST THE HUB OF A NON-PENUMBRA MICROCATHETER AND, THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING A NEW SMART COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8597389 ↗
• MalfunctionDec 19, 2018Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY ADVANCED FOUR COILS INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ADVANCING A SMART COIL AS THE FIFTH COIL THROUGH THE SAME MICROCATHETER, THE PHYSICIAN FELT RESISTANCE IN THE MIDDLE OF THE MICROCATHETER AND COULD NOT ADVANCE THE SMART COIL ANY FURTHER. THE PHYSICIAN MADE SEVERAL ATTEMPTS TO RETRACT AND ADVANCE THE COIL AND FELT RESISTANCE AT THE SAME LOCATION WITHIN THE MICROCATHETER. SUBSEQUENTLY, THE PUSHER ASSEMBLY BECAME KINKED AND THE SMART COIL WAS THEREFORE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8179198 ↗
• MalfunctionDec 12, 2018Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED SIX COILS USING A DOUBLE CATHETER TECHNIQUE. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A SMART COIL WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN ATTEMPTED TO ADVANCE THE SMART COIL OUT OF ITS INTRODUCER SHEATH OUTSIDE OF THE PATIENT BUT AGAIN FELT RESISTANCE, AND THE PUSHER ASSEMBLY BECAME KINKED. THE PROCEDURE WAS THEN COMPLETED USING NEW SMART COILS AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8155890 ↗
• MalfunctionNov 9, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS, CALCIFIED AND NARROWING VESSELS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA COIL AND FOUR SMART COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN WAS THEN UNABLE TO ADVANCE TWO OTHER SMART COILS OUT OF THEIR INTRODUCER SHEATHS AND INTO THE MICROCATHETER; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING SIX ADDITIONAL SMART COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8057346 ↗
• MalfunctionJun 1, 2018Break; Inadequacy of Device Shape and/or Size; Break; Inadequacy of Device Shape and/or Size

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, ONE SMART COIL WAS REMOVED FROM THE NON-PENUMBRA MICROCATHETER BECAUSE THE SMART COIL WAS THE WRONG SIZE. WHILE INSPECTING THE SMART COIL OUTSIDE OF THE PATIENT, THE HOSPITAL STAFF FOUND THAT THE SMART COIL WAS BROKEN. THE PROCEDURE WAS, THEREFORE, COMPLETED USING ADDITIONAL SMART COIL, OTHER COILS, AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7563416 ↗
• MalfunctionApr 26, 2018Migration or Expulsion of Device; Malposition of Device; Migration or Expulsion of Device; Malposition of Device

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT CAROTID CAVE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, APPROXIMATELY ONE CENTIMETER OF THE THIRD SMART COIL PROLAPSED INTO THE PARENT ARTERY LUMEN. IT IS UNCLEAR IF THERE WAS A DETACHMENT ISSUE OR IF THE COIL PROLAPSE WAS DUE TO TENSION WITHIN THE SYSTEM ITSELF. THE PROCEDURE WAS COMPLETED USING AN ADDITIONAL SMART COIL. THE PATIENT WAS DISCHARGED THE NEXT DAY, (B)(6) 2018 AND THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7464678 ↗
• MalfunctionMar 6, 2018Physical Resistance; Mechanical Jam; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT AND RIGHT VERTEBRAL ARTERY (VA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED SIX SMART COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE AND NEW SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE WHEN PASSING OVER THE HUB OF THE MICROCATHETER AND SUBSEQUENTLY, THE SMART COIL BECAME STUCK; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL SMART COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7317840 ↗
• MalfunctionJan 16, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT TRANSVERSE SINUS VENOUS USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED (B)(4) SMART COILS AND (B)(4) COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN WAS THEN UNABLE TO ADVANCE ANOTHER SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND ADDITIONAL COILS WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7197820 ↗
• MalfunctionDec 27, 2017Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A DURAL ARTERIOVENOUS FISTULA (D-AVF) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED TWO SMART COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE SMART COIL BECAME STUCK IN ITS INTRODUCER SHEATH AND WOULD NOT ADVANCE FURTHER THROUGH THE MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7149405 ↗
• InjuryJun 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017 THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE TO TREAT A BASILAR BIFURCATION ANEURYSM USING PENUMBRA SMART COILS (SMART COILS) WITH NO COMPLICATIONS. THE NEXT DAY, THE PATIENT COMPLAINED OF LEFT BODY WEAKNESS. A MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED AND REVEALED A SMALL RIGHT PONTINE INFARCT. THE PATIENT REMAINED HOSPITALIZED WITH NO OTHER ACTIONS TAKEN AND WAS DISCHARGED TO REHAB IN STABLE CONDITION ON (B)(6) 2017. THE REPORTED RIGHT PONTINE INFARCT WAS ADJUDICATED BY THE PHYSICIAN TO BE POSSIBLY RELATED TO THE DISEASE STATE AND THE SMART COIL SYSTEM AND PROBABLY RELATED TO THE PROCEDURE.

  Patient problems: Infarction, Cerebral

  MAUDE report 6675282 ↗
• InjuryMar 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY-POSTERIOR COMMUNICATING ARTERY (ICA-PCOM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THERE WAS MILD THROMBUS FORMATION IN THE INFERIOR TEMPORAL MIDDLE CEREBRAL ARTERY (MCA) BRANCH. THE THROMBUS RESOLVED ON ITS OWN ON THE SAME DAY AND NO ACTION WAS TAKEN. THE THROMBUS FORMATION WAS ADJUDICATED TO BE AN ADVERSE EVENT WITH A PROBABLE RELATIONSHIP TO THE PROCEDURE AND DISEASE STATE AND A POSSIBLE RELATIONSHIP TO THE SMART COIL SYSTEM.

  Patient problems: Thrombus

  MAUDE report 6442661 ↗
• MalfunctionSep 27, 2016Retraction Problem; Physical Resistance; Mechanical Jam; Retraction Problem; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO RETREAT AN INTERNAL CAROTID ARTERY (ICA) TERMINUS ANEURYSM USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN MADE TWO ATTEMPTS TO DEPLOY THE FIRST SMART COIL ACROSS A VERY WIDE NECK BUT THEN DETERMINED THAT THE NECK OF THE ANEURYSM WAS TOO WIDE FOR THE COIL TO BE STABLE WITHOUT A STENT. THEREFORE, THE SMART COIL WAS RETRACTED; HOWEVER, UPON RETRACTION, THE PHYSICIAN MENTIONED FEELING RESISTANCE AND SUBSEQUENTLY, THE SMART COIL BECAME STUCK IN THE NON-PENUMBRA MICROCATHETER. THE MICROCATHETER WAS THEN REMOVED WITH THE SMART COIL STUCK INSIDE AND THE PROCEDURE WAS COMPLETED USING A NEW NON-PENUMBRA MICROCATHETER AND THREE NEW SMART COILS. IT SHOULD BE NOTED THAT THE PHYSICIAN USED A ROTATING HEMOSTASIS VALVE (RHV) AND MAINTAINED A CONTINUOUS FLUSH DURING THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5982129 ↗