LP Coil System RBYPCLP15Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00815948021921), received between May 28, 2020 and Jan 30, 2024 — classified as 42 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (30 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK FROM THE SUPERIOR MESENTERIC ARTERY (SMA) TO THE INFERIOR MESENTERIC ARTERY (IMA) USING PACKING COIL LPS, A RUBY COIL LP, A LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL LP INTO THE TARGET LOCATION USING THE MICROCATHETER. THE PHYSICIAN THEN ADVANCED A PACKING COIL LP INTO THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE PACKING COIL LP FAILED TO DETACH. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PHYSICIAN THEN ADVANCED ANOTHER PACKING COIL LP INTO THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE; HOWEVER, THE PACKING COIL LP FAILED TO DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE PACKING COIL LP. WHILE RETRACTING THE PACKING COIL LP, IT UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN INJECTED SALINE INTO THE MICROCATHETER AND SUCCESSFULLY IMPLANTED THE DETACHED PACKING COIL LP INTO THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING THE SAME M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607548 ↗
• MalfunctionJan 3, 2024Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GI BLEED IN THE RIGHT GASTRIC ARTERY USING PACKING COIL LPS, A LP DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT''S ANATOMY WAS VERY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE COILS IN THE TARGET LOCATION. NEXT, THE PHYSICIAN EXPERIENCED DIFFICULTY WHILE ADVANCING A PACKING COIL LP TO THE TARGET VESSEL, THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE MICROCATHETER AND PACKING COIL LP AS A UNIT. AFTER REMOVAL THE PHYSICIAN FOUND THAT THE PACKING COIL LP HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING AN ADDITIONAL PACKING COIL LP, THE SAME HANDLE, 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 18437769 ↗
• MalfunctionNov 3, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILEOCOLIC ARTERY USING A RUBY COIL LP, PACKING COIL LPS, AN LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED ONE RUBY COIL LP AND TWO PACKING COIL LPS IN THE VESSEL. THE PHYSICIAN THEN ADVANCED THE LAST PACKING COIL LP INTO THE TARGET LOCATION AND MADE AN ATTEMPT TO DETACH IT USING THE HANDLE. IT WAS REPORTED THAT THE PHYSICIAN THOUGHT THE PACKING LP WAS DETACHED IN THE VESSEL. HOWEVER, WHILE RETRACTING THE PUSHER ASSEMBLY, IT WAS NOTED THAT THE PACKING COIL LP WAS STILL ATTACHED TO THE PUSHER ASSEMBLY. THE PACKING COIL LP UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER WITH THE DISTAL END OF THE COIL PARTIALLY OUTSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL LP WAS REMOVED. THE PHYSICIAN WAS SATISFIED WITH THE COILS PLACED IN THE VESSEL AND ENDED THE PROCEDURE AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066433 ↗
• MalfunctionAug 18, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT RENAL ARTERY USING PACKING COIL LPS, POD PACKING COILS (POD PC), AN LP SYSTEM DETACHMENT HANDLE (HANDLE) AND A MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE PACKING COIL LP IN THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE PACKING COIL LP FAILED TO DETACH. SUBSEQUENTLY, WHILE ATTEMPTING TO DETACH THE SAME PACKING COIL LP MANUALLY, THE COIL DETACHED IN THE MICROCATHETER. THEREFORE, THE PHYSICIAN PUSHED THE PACKING COIL LP INTO THE TARGET VESSEL USING THE PUSHER ASSEMBLY. THE SAME ISSUE OCCURRED WITH THE NEXT PACKING COIL LP; THEREFORE, THE PACKING COIL LP WAS ALSO PUSHED INTO THE TARGET VESSEL USING THE PUSHER ASSEMBLY. NEXT, WHILE ATTEMPTING TO ADVANCE THE POD PC THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD PC WOULD NOT ADVANCE. THEREFORE, THE POD PC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS. IT WAS REPORTED THAT THE COILS WERE RELEASED MANUALLY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254523 ↗
• MalfunctionMar 1, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE 2 ENDOLEAK IN THE INFERIOR MESENTERIC ARTERY (IMA) USING PACKING COIL LPS, RUBY COIL LPS, AN LP SYSTEM DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, A 6FR NON-PENUMBRA SHEATH, AND A DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE SHEATH AND DIAGNOSTIC CATHETER WERE ADVANCED INTO THE SUPERIOR MESENTERIC ARTERY (SMA), AND THE PHYSICIAN OBTAINED ACCESS TO THE ENDOLEAK THROUGH THE IMA USING THE MICROCATHETER. THEN, THE PHYSICIAN ADVANCED A PACKING COIL LP TO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE COIL FAILED TO DETACH. THE PHYSICIAN PULLED THE PUSHER ASSEMBLY OF THE PACKING COIL LP FURTHER BACK IN AN ATTEMPT TO DETACH THE COIL; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE PACKING COIL LP. WHILE RETRACTING THE PACKING COIL LP APPROXIMATELY HALFWAY BACK THROUGH THE MICROCATHETER, THE PACKING COIL LP UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THE PHYSICIAN THEN FLUSHED THE DETACHED PACKING COIL LP OUT OF THE MICROCATHETER AND INTO THE TARGET LOCATION USING A 1CC SYRINGE AND, SUBSEQUENTLY, THE PACKING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13635108 ↗
• MalfunctionNov 11, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING PACKING COIL LPS, RUBY COIL LPS AND A MICROCATHETER. DURING THE PROCEDURE, TWO PACKING COIL LPS AND ONE RUBY COIL LP WOULD NOT ADVANCE PAST THEIR INITIAL POSITION WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THE TWO PACKING COIL LPS AND ONE RUBY COIL LP WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW PACKING COIL LPS, 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 12800751 ↗
• MalfunctionNov 4, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A PACKING COIL LP. DURING THE PROCEDURE, THE PACKING COIL LP WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PACKING COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752585 ↗
• 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 12741119 ↗
• MalfunctionOct 25, 2021Failure to Advance; Failure to Advance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12695010 ↗
• MalfunctionOct 15, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) VESSEL USING PACKING COIL LP¿S, A RUBY COIL LP, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO PACKING COIL LP¿S AND A RUBY COIL LP PAST THE HUB OF THE MICROCATHETER. THEREFORE, BOTH PACKING COIL LP¿S AND RUBY COIL LP WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW PACKING COIL LPS, NEW RUBY COIL LPS, 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 12639775 ↗
• MalfunctionOct 12, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT AND RIGHT GASTRIC BRANCH USING RUBY COIL LPS, PACKING COIL LPS, RUBY COILS, A LP SYSTEM DETACHMENT HANDLE (HANDLE), AND NON-PENUMBRA MICROCATHETERS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO THE LEFT GASTRIC BRANCH USING THE FIRST MICROCATHETER AND ATTEMPTED TO DETACH THE COIL USING THE HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE RUBY COIL LP USING A NEEDLE DRIVER BUT, THE COIL STILL FAILED TO DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO DETACH FIVE RUBY COIL LPS AND FOUR PACKING COIL LPS IN THE TARGET LOCATION USING THE HANDLE. THEREFORE, THE PHYSICIAN USED THE NEEDLE DRIVER TO MANUALLY DETACH THE PACKING COIL LPS AND RUBY COIL LPS. NEXT, WHILE ATTEMPTING TO PLACE A RUBY COIL IN THE RIGHT GASTRIC BRANCH, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL THROUGH THE TIP OF THE SECOND MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND THE SAME MICROCATHETER. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12619496 ↗
• MalfunctionOct 2, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE IN THE GASTRODUODENAL ARTERY (GDA) USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO PACKING COIL LPS WOULD NOT ADVANCE OUT OF INTRODUCER SHEATHS/ FRICTION LOCKS. THEREFORE, THE PACKING COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COIL LPS AND THE SAME PROGREAT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12566488 ↗
• MalfunctionOct 2, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE IN THE GASTRODUODENAL ARTERY (GDA) USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO PACKING COIL LPS WOULD NOT ADVANCE OUT OF INTRODUCER SHEATHS/ FRICTION LOCKS. THEREFORE, THE PACKING COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COIL LPS AND THE SAME PROGREAT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12566487 ↗
• MalfunctionSep 14, 2021Failure to Advance; Physical Resistance/Sticking; Premature Separation; Failure to Advance; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR EPIGASTRIC ARTERY USING PACKING COIL LPS, A NON-PENUMBRA MICROCATHETER, AND A BASE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED NINE LP COILS IN THE TARGET LOCATION USING THE MICROCATHETER. NEXT, WHILE ADVANCING A PACKING COIL LP THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE PACKING COIL LP BECAME STUCK AND UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL LP WAS REMOVED FROM THE PATIENT. SUBSEQUENTLY, THE HOSPITAL TECHNOLOGIST FLUSHED THE PACKING COIL LP OUT OF THE MICROCATHETER ON THE BACK TABLE. IT WAS REPORTED THAT THE VESSEL MADE A TIGHT CURVE OUT OF THE BASE CATHETER AND THAT ALL PROPER FLUSHING TECHNIQUES WERE USED DURING EMBOLIZATION. THE PHYSICIAN THEN REGAINED ACCESS AND COMPLETED THE PROCEDURE USING A RUBY COIL LP, ANOTHER LP 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 12471038 ↗
• MalfunctionSep 9, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A PACKING COIL LP. DURING THE PROCEDURE, THE PACKING COIL LP WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PACKING COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12450607 ↗
• MalfunctionAug 23, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING PACKING COIL LPS, RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A PACKING COIL LP, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE DISTAL END OF THE MICROCATHETER AND INSIDE THE TARGET VESSEL. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PACKING COIL LP OF A SMALLER SIZE 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 12356724 ↗
• MalfunctionAug 6, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL ARTERIOVENOUS MALFORMATION (AVM) USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO RUBY COIL LPS WERE DELIVERED SUCCESSFULLY THROUGH THE MICROCATHETER INTO THE TARGET LOCATION. WHILE ADVANCING THE NEXT PACKING COIL LP THROUGH THE MIDDLE OF THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED. THEREFORE, THE PACKING COIL LP WAS REMOVED. IT WAS REPORTED THAT THE MICROCATHETER WAS FLUSHED AND THE PACKING COIL LP WAS HYDRATED BUT THE ISSUE REMAINED UNRESOLVED AND THE PHYSICIAN WAS UNABLE TO LOCATE ANY NOTICEABLE DAMAGE ON THE PACKING COIL LP. THE PROCEDURE WAS COMPLETED USING ANOTHER PACKING COIL LP, POD4, TWO POD5S, TWO RUBY 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 12288967 ↗
• MalfunctionJul 12, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE II ENDOLEAK USING PACKING COIL LPS, PENUMBRA SMART COILS, A NON-PENUMBRA COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED SEVERAL SMART COILS, PACKING COIL LPS AND NON-PENUMBRA COILS IN THE TARGET LOCATION USING THE MICROCATHETER. WHILE ATTEMPTING TO PLACE ANOTHER PACKING COIL LP IN THE TARGET VESSEL, THE HOSPITAL TECHNICIAN WAS UNABLE TO ADVANCE THE PACKING COIL LP PAST THE FRICTION LOCK. THE PHYSICIAN ALSO TRIED ADVANCING THE SAME PACKING COIL LP; HOWEVER, IT WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PACKING COIL LP, ADDITIONAL LP COILS AND 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 12153752 ↗
• MalfunctionMay 27, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING PACKING COIL LPS, PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED RUBY COIL LPS IN THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN THEN ADVANCED A PACKING COIL LP AS THE LAST COIL INTO THE VESSEL AND MADE MULTIPLE ATTEMPTS TO DETACH IT USING A HANDLE; HOWEVER, THE PACKING COIL LP FAILED TO DETACH. IT WAS ALSO REPORTED THAT THE DARK GREY PORTION AT THE END OF THE PUSHER ASSEMBLY HAD SEPARATED BUT THE PACKING COIL LP WOULD NOT DETACH. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PACKING 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 11898232 ↗
• MalfunctionMay 5, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A PACKING COIL LP WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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

  MAUDE report 11780754 ↗
• MalfunctionApr 14, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING PACKING COIL LPS. DURING THE PROCEDURE, A PACKING COIL LP WOULD NOT ADVANCE THROUGH THE INTRODUCER SHEATH AT ALL. IT WAS REPORTED THERE WAS TENSION, WHICH CAUSED THE PUSHER ASSEMBLY TO KINK. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11667898 ↗
• MalfunctionApr 1, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) IN THE GASTRODUODENAL ARTERY (GDA) USING A PACKING COIL LP, A RUBY COIL LP, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A PACKING COIL LP WOULD NOT ADVANCE FROM THE STARTING POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A RUBY COIL LP; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW 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 11605619 ↗
• MalfunctionMar 16, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ABDOMINAL AORTA USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, AFTER ADVANCING A PACKING COIL LP APPROXIMATELY A FEW CENTIMETERS INTO THE MICROCATHETER, THE PHYSICIAN BENT THE PUSHER ASSEMBLY OF THE PACKING COIL LP. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PACKING COIL LP AND ADDITIONAL COILS WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11499307 ↗
• MalfunctionMar 8, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PACKING COIL LPS. DURING THE PROCEDURE, A PACKING COIL LP WOULD NOT ADVANCE OUT FROM ITS INTRODUCER SHEATH AND INTO MICROCATHETER AND, SUBSEQUENTLY, THE PHYSICIAN BENT THE PUSHER ASSEMBLY OF THE PACKING COIL LP. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11440901 ↗
• MalfunctionMar 8, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED IN MULTIPLE VESSELS USING PACKING COIL LPS AND RUBY COIL LPS WITH A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN USED TWO RUBY COIL LPS TO EMBOLIZE THE FIRST VESSEL. WHILE ATTEMPTING TO EMBOLIZE THE SECOND VESSEL, TWO PACKING COIL LPS AND TWO RUBY COIL LPS WOULD NOT ADVANCE FROM THEIR INITIAL POSITIONS WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THESE COILS WERE REMOVED FROM THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER SIX LP 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 11440779 ↗