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LP Coil System RBYLP0304Recalls & reported problems

Penumbra, Inc. · Ruby Coil LP, 3 mm x 4 cm · Class 2 · Implant

All models of LP Coil System (38)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
20
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00815948021778), received between Mar 3, 2020 and Oct 7, 2022 — classified as 1 injury, 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

Device problems

  • Failure to Advance12
  • Physical Resistance/Sticking10
  • Separation Failure3
  • Break2
  • Failure to Fold2
  • Premature Separation2
  • Material Deformation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions18
  • No Consequences Or Impact To Patient4
  • Perforation1

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 7, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COIL LPS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, AFTER ADVANCING A RUBY COIL LP INTO THE TARGET LOCATION, THE PHYSICIAN DECIDED TO REPOSITION THE LANTERN. THEREFORE, THE RUBY COIL LP WAS REMOVED OUT FROM THE MICROCATHETER. SUBSEQUENTLY, WHILE RETRACING THE COIL BACK INTO THE INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND, CONSEQUENTLY, THE RUBY COIL LP HAD DETACHED FROM THE PUSHER ASSEMBLY. THE PHYSICIAN THEN ADVANCED A NEW RUBY COIL LP TO THE TARGET LOCATION; HOWEVER, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL LP TO REPOSITION THE LANTERN. WHILE RETRACTING THE RUBY COIL LP THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL LP UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COIL LPS AND A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15565392 ↗
  • MalfunctionDec 6, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL LP APPROXIMATELY TEN CENTIMETERS WITHIN ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PHYSICIAN THEN PLACED A NEW RUBY COIL LP IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE NEXT RUBY COIL LP APPROXIMATELY TEN CENTIMETERS WITHIN ITS INTRODUCER SHEATH, THE SAME ISSUE OCCURRED. THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12933656 ↗
  • MalfunctionDec 3, 2021Failure to Fold; Failure to Advance; Physical Resistance/Sticking; Failure to Fold; Failure to Advance; Physical Resistance/Sticking

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS AND A MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE RUBY COIL LP TO THE TARGET VESSEL, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE RUBY COIL LP WOULD NOT FULLY EXIT THE MICROCATHETER AND WOULD NOT TAKE ITS INTENDED SHAPE. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL LP 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 12927338 ↗
  • MalfunctionNov 30, 2021Separation Failure; Separation Failure

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR COLLATERAL USING RUBY COIL LPS, AN LP SYSTEM DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DETACHED TWO RUBY COIL LPS IN THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL LP TO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL LP AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12902345 ↗
  • MalfunctionNov 2, 2021Failure to Advance; Failure to Advance

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS AND A MICROCATHETER. DURING THE PROCEDURE, THREE RUBY COIL LPS WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE THREE RUBY COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COIL LPS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12741121 ↗
  • MalfunctionOct 22, 2021Separation Failure; Separation Failure

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR RIGHT HEPATIC ARTERY USING RUBY COILS LPS AND A LP SYSTEM DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, AFTER ADVANCING THE RUBY COIL LP, THE PHYSICIAN WAS UNABLE TO DETACH THE RUBY COIL LP WITH THE HANDLE NOR MANUALLY DETACH IT WITH THEIR HANDS. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP THAT WAS MANUALLY DETACHED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12682818 ↗
  • MalfunctionAug 27, 2021Separation Failure; Separation Failure

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COIL LPS AND AN LP SYSTEM DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED INTACT. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED ANOTHER LP COIL IN THE TARGET VESSEL USING THE SAME HANDLE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL LP COILS AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12375832 ↗
  • MalfunctionJul 19, 2021Failure to Advance; Failure to Advance

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE COLIC ARTERY BRANCH USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE TECH EXPERIENCED DIFFICULTY ADVANCING THE RUBY COIL LP THROUGH THE INTRODUCER SHEATH. IT WAS REPORTED THAT THE RUBY COIL LP WOULD NOT ADVANCE THROUGH THE INTRODUCER SHEATH AND INTO THE MICROCATHETER. SUBSEQUENTLY, THE RUBY COIL LP WAS REMOVED. THE TECH THEN ATTEMPTED TO ADVANCE THE RUBY COIL LP ON THE BACK TABLE UNSUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12186825 ↗
  • MalfunctionJul 16, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE OUT FROM THE STARTING POSITION WITH ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COIL LPS AND PACKING COIL LPS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12185882 ↗
  • MalfunctionJul 9, 2021Failure to Fold; Failure to Fold

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING PACKING COIL LPS AND RUBY COIL LPS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO GET A PACKING COIL LP AND RUBY COIL LP (F102510 AND F99270) TO ANCHOR AND FORM IN THE SMALL AREA OF THE GDA. SUBSEQUENTLY, THE PACKING COIL LP AND RUBY COIL LP WERE REMOVED. THE PHYSICIAN THEN ATTEMPTED TO USE A RUBY COIL LP (F99986); HOWEVER, THE COIL WAS UNABLE TO ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. IT WAS REPORTED THE PHYSICIAN ATTEMPTED TO TROUBLESHOOT BY HOLDING THE BLACK STRIPE DISTALLY, BUT WAS UNSUCCESSFUL. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12147017 ↗
  • MalfunctionMay 30, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL LP WAS STUCK IN THE STARTING POSITION AND WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COIL LPS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11905919 ↗
  • MalfunctionMay 14, 2021Failure to Advance; Premature Separation; Failure to Advance; Premature Separation

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A BRANCH OFF POSTERIOR TIBIAL ARTERY USING RUBY COIL LPS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL LP WAS UNABLE TO ADVANCE PAST THE FRICTION LOCK WITHIN THE INTRODUCER SHEATH. THE PHYSICIAN ATTEMPTED TO MODIFY HAND PLACEMENT WITH THE RUBY COIL LP TO DISENGAGE THE FRICTION LOCK TO TROUBLESHOOT; HOWEVER, WHILE TROUBLESHOOTING, THE RUBY COIL LP DETACHED FROM THE PUSHER ASSEMBLY BEFORE ENTERING THE MICROCATHETER. THEREFORE, THE RUBY COIL LP WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO ADVANCE THE NEXT THREE RUBY COIL LPS PAST THE FRICTION LOCK. IT WAS ALSO REPORTED WHILE ATTEMPTING TO USE THE SAME TROUBLESHOOTING TECHNIQUE, ALL THREE RUBY COIL LPS DETACHED FROM THE PUSHER ASSEMBLY WITHIN THE INTRODUCER SHEATH BEFORE ENTERING THE MICROCATHETER. THEREFORE, ALL THREE RUBY COIL LPS WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS, OTHER 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 11827275 ↗
  • MalfunctionMay 4, 2021Failure to Advance; Failure to Advance

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC ARTERY USING RUBY COIL LPS. DURING THE PROCEDURE, TWO RUBY COIL LPS WERE STUCK IN THEIR INTRODUCER SHEATHS AND WOULD NOT ADVANCE. THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11773567 ↗
  • MalfunctionMar 16, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A DIALYSIS FISTULA USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO RUBY COIL LPS WERE STUCK IN THE STARTING POSITION AND WOULD NOT ADVANCE AT ALL THROUGH THE INTRODUCER SHEATH. THEREFORE, BOTH RUBY COIL LPS WERE REMOVED. THE PROCEDURE HAD ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11497709 ↗
  • MalfunctionMar 16, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A DIALYSIS FISTULA USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO RUBY COIL LPS WERE STUCK IN THE STARTING POSITION AND WOULD NOT ADVANCE AT ALL THROUGH THE INTRODUCER SHEATH. THEREFORE, BOTH RUBY COIL LPS WERE REMOVED. THE PROCEDURE HAD ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11497694 ↗
  • MalfunctionMar 2, 2021Failure to Advance; Failure to Advance

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BLEED USING A RUBY COIL LP. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP. 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 11398652 ↗
  • InjuryFeb 25, 2021Break; Premature Separation; Break; Premature Separation

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT PROFUNDA BRANCH USING A RUBY COIL LP, A NON-PENUMBRA SUPPORT CATHETER, A NON-PENUMBRA BALLOON STENT, A NON-PENUMBRA STENT, AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN PLACED A BALLOON STENT TO COVER A PERFORATION OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA); HOWEVER, THE PERFORATION PERSISTED. NEXT, THE PHYSICIAN PERFORMED A SECOND ANGIOGRAM AT A DIFFERENT ANGLED THAT REVEALED THE PERFORATION WAS OFF A SMALL PROFUNDA BRANCH. IT WAS REPORTED THAT THE PERFORATION WAS THE RESULT OF A GUIDEWIRE BEING USED TO DELIVER THE SHEATH AT THE BEGINNING OF THE PROCEDURE. SUBSEQUENTLY, PROLONGED BALLOON INFLATION DID NOT RESOLVE THE PERFORATION. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO PLACE A RUBY COIL LP INTO THE LEFT PROFUNDA PERFORATING BRANCH; HOWEVER, IT WAS UNSUCCESSFUL AS THE VESSEL MEASURED APPROXIMATELY 0.5 MILLIMETERS AND ACCESS WAS LOST TO THE LEFT PROFUNDA PERFORATING BRANCH. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL LP. UPON RETRACTION, THE RUBY COIL LP GOT STUCK AT THE TIP OF THE SUPPORT CATHETER. SUBSEQUENTLY, THE RUBY COIL LP UNINTENTIONALLY DETACHED IN THE SFA. THEREFORE, THE DETA

    Patient problems: Perforation

    MAUDE report 11380605 ↗
  • MalfunctionJan 29, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOPLASTIC RIGHT PULMONARY ARTERY USING RUBY COIL LPS, PACKING COIL LPS, AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL LP WAS STUCK IN THE STARTING POSITION AND WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. NEXT, WHILE ATTEMPTING TO ADVANCE A PACKING COIL LP INTO THE TARGET LOCATION, THE PHYSICIAN LOST ACCESS WITH THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE PACKING COIL LP AND ATTEMPTED TO RE-SHEATH THE COIL; HOWEVER, THE PACKING COIL LP COULD NOT BE RETRACTED BACK INTO THE ITS INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP, A NEW PACKING COIL LP AND, THE SAME MICROCATHETER. 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 11251071 ↗
  • MalfunctionSep 25, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE HEPATIC ARTERY USING RUBY COIL LPS, GUIDE CATHETER AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL LP, THE HOSPITAL TECHNICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL LP WOULD NOT ADVANCE FROM THE STARTING POSITION WITHIN THE INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LP WAS REMOVED AND THE MICROCATHETER WAS FLUSHED WITH SALINE. IT WAS REPORTED THAT THE RUBY COIL LP WAS ALSO PLACED INTO A BOWL OF SALINE. WHILE MAKING ANOTHER ATTEMPT TO ADVANCE THE SAME RUBY COIL LP, THE PHYSICIAN EXPERIENCED THE SAME RESISTANCE; SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE RUBY COIL LP BECAME BENT AND, THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN PLACED A NEW RUBY COIL LP IN THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE ANOTHER RUBY COIL LP, THE PHYSICIAN INITIALLY EXPERIENCED RESISTANCE WHILE ADVANCING THE COIL FROM THE STARTING POSITION WITHIN THE INTRODUCER SHEATH. SUBSEQUENTLY, THE RUBY COIL LP WAS ABLE TO ADVANCE PAST THE FRICTION LOCK WITHIN THE INTRODUCER SHEATH AND WAS SUCCESSFULLY PLACED IN THE VESSEL. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVE

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

    MAUDE report 10586956 ↗
  • MalfunctionMar 3, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE COLIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCING THE RUBY COIL OUT OF ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COIL KINKED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9783055 ↗

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