LP Coil System RBYPCLP60Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00815948021952), received between Mar 31, 2020 and Jan 7, 2025 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (18 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2025Failure to Fold; Physical Resistance/Sticking; Premature Separation; Failure to Fold; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILIAC ARTERY USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED MULTIPLE LP COILS INTO THE TARGET LOCATION. WHILE ADVANCING A PACKING COIL LP INTO THE TARGET LOCATION, THE PHYSICIAN MET RESISTANCE. THE PHYSICIAN RETRACTED THE PACKING COIL LP AND RE-ADVANCED IT INTO THE VESSEL; HOWEVER, THE COIL WOULD NOT TAKE ITS INTENDED SHAPE AND REMAINED STIFF AND STRAIGHT. THE PHYSICIAN ATTEMPTED TO RE-ADVANCE THE COIL TWICE, BUT THE SAME ISSUE OCCURRED. THE PHYSICIAN THEN DECIDED TO REMOVE THE PACKING COIL LP. WHILE RETRACTING THE PACKING COIL LP, THE COIL UNINTENTIONALLY DETACHED PARTIALLY IN THE PATIENT'S ANATOMY AND PARTIALLY IN THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO FLUSH THE MICROCATHETER WITH SALINE TO PUSH THE DETACHED PACKING COIL LP INTO THE TARGET VESSEL; HOWEVER, IT WOULD NOT MOVE. THE PHYSICIAN THEN ADVANCED A GUIDE WIRE INTO THE MICROCATHETER AND ATTEMPTED TO PUSH THE PACKING COIL LP INTO THE VESSEL; HOWEVER, IT WOULD NOT MOVE. WHILE EXERTING ADDITIONAL FORCE TO MOVE THE COIL, THE MICROCATHETER BACKED OUT OF THE VESSEL. A SNARE DEVICE WAS THEN ADV

  Patient problems: Foreign Body In Patient

  MAUDE report 21097437 ↗
• MalfunctionApr 5, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A PACKING COIL LP, NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DETACH TWO NON-PENUMBRA COILS; HOWEVER, BOTH THE COILS WOULD NOT DETACH. THEREFORE, THE COILS WERE REMOVED AND A NEW MICROCATHETER WAS USED TO REGAIN ACCESS. NEXT, THE PACKING COIL LP WAS ADVANCED BUT THE PHYSICIAN EXPERIENCED RESISTANCE ADVANCING THE COIL OUT OF THE DISTAL END OF THE MICROCATHETER. WHILE RETRACTING THE PACKING COIL LP INTO THE MICROCATHETER, THE COIL FRACTURED IN HALF BUT REMAINED CONNECTED BY THE CENTER PIECE OF THE COIL. THEREFORE, THE MICROCATHETER CONTAINING THE PACKING COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED BY REGAINING ACCESS TO THE TARGET LOCATION AND USING NON-PENUMBRA COILS AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19052237 ↗
• MalfunctionJun 7, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE AORTOPULMONARY COLLATERAL ARTERIES USING PACKING COIL LPS, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING A PACKING COIL LP INTO THE TARGET LOCATION, THE PHYSICIAN DECIDED TO RETRACT AND REPOSITION THE PACKING COIL LP. SUBSEQUENTLY, UPON RETRACTING THE PACKING COIL LP, THE PACKING COIL LP UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL LP WAS REMOVED FROM THE PATIENT AND THE COIL WAS FLUSHED OUT OF THE MICROCATHETER. THEN, A SECOND PACKING COIL LP WAS ADVANCED INTO THE TARGET LOCATION AND THE PHYSICIAN ALSO DECIDED TO RETRACT AND REPOSITION THE SECOND PACKING COIL LP; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE MICROCATHETER CONTAINING THE SECOND DETACHED PACKING COIL LP WAS REMOVED FROM THE PATIENT AND THE COIL WAS FLUSHED OUT OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING 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 17082392 ↗
• MalfunctionNov 22, 2022Inadequacy of Device Shape and/or Size; Premature Separation; Inadequacy of Device Shape and/or Size; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COLLATERAL ARTERY USING PACKING COIL LPS, POD PACKING COILS (POD PC), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE A POD PC INTO THE VESSEL; HOWEVER, THE POD PC WAS DETERMINED TO BE TOO LARGE AND WOULD NOT PACK IN THE VESSEL. AFTER MAKING A SECOND ATTEMPT TO ADVANCE THE COIL, THE PHYSICIAN DECIDED TO REMOVE THE POD PC. HOWEVER, WHILE RETRACTING, THE POD PC HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED POD PC. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE NEXT PACKING COIL LP INTO THE VESSEL, BUT THE COIL WAS DETERMINED TO BE THE WRONG SIZE AND WOULD NOT ADVANCE INTO THE VESSEL. SUBSEQUENTLY, WHILE RETRACTING, THE PACKING COIL LP DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED A SYRINGE TO ASPIRATE THE DETACHED PACKING COIL LP OUT OF THE MICROCATHETER. THE SAME ISSUE THEN OCCURRED WITH THE NEXT PACKING COIL LP AND THE PHYSICIAN REMOVED THE DETACHED PACKING COIL LP USING A SYRINGE. IT WAS ALSO REPORTED THAT THE MICROCATHETER WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMALL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15846317 ↗
• MalfunctionNov 22, 2022Inadequacy of Device Shape and/or Size; Premature Separation; Inadequacy of Device Shape and/or Size; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COLLATERAL ARTERY USING PACKING COIL LPS, POD PACKING COILS (POD PC), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE A POD PC INTO THE VESSEL; HOWEVER, THE POD PC WAS DETERMINED TO BE TOO LARGE AND WOULD NOT PACK IN THE VESSEL. AFTER MAKING A SECOND ATTEMPT TO ADVANCE THE COIL, THE PHYSICIAN DECIDED TO REMOVE THE POD PC. HOWEVER, WHILE RETRACTING, THE POD PC HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED POD PC. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE NEXT PACKING COIL LP INTO THE VESSEL, BUT THE COIL WAS DETERMINED TO BE THE WRONG SIZE AND WOULD NOT ADVANCE INTO THE VESSEL. SUBSEQUENTLY, WHILE RETRACTING, THE PACKING COIL LP DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED A SYRINGE TO ASPIRATE THE DETACHED PACKING COIL LP OUT OF THE MICROCATHETER. THE SAME ISSUE THEN OCCURRED WITH THE NEXT PACKING COIL LP AND THE PHYSICIAN REMOVED THE DETACHED PACKING COIL LP USING A SYRINGE. IT WAS ALSO REPORTED THAT THE MICROCATHETER WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMALL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15846282 ↗
• MalfunctionMay 18, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) AND THE GASTROEPIPLOIC ARTERY (GEA) USING RUBY COIL LPS, A PACKING COIL LP, A LP SYSTEM DETACHMENT HANDLE (LP HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE RUBY COIL LPS INTO THE TARGET VESSEL USING THE LP HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL LP INTO THE TARGET VESSEL; HOWEVER, THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL LP BACK INTO THE MICROCATHETER TO REPOSITION IT. WHILE RETRACTING, THE RUBY COIL LP UNINTENTIONALLY DETACHED AND MIGRATED DISTALLY INTO THE LEFT GASTROEPIPLOIC ARTERY (LGEA). THE RUBY COIL LP WAS LEFT IN THE AREA IT HAD MIGRATED TO. THE PHYSICIAN THEN IMPLANTED THREE ADDITIONAL RUBY COIL LPS INTO THE TARGET VESSEL USING THE LP HANDLE. NEXT, THE PHYSICIAN ADVANCED A PACKING COIL LP INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE LP HANDLE. HOWEVER, THE PACKING COIL LP FAILED TO DETACH. IT WAS REPORTED THAT THE PHYSICIAN PULLED THE TRIGGER OF THE LP HANDLE BACK AND SAW THE TWO MARKERS INDICATING THAT THE PACKING COIL LP HAD DETACHED. HOWEVER, WHEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14432211 ↗
• MalfunctionDec 8, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COIL LPS, PACKING COIL LPS, AN LP SYSTEM DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP AND PACKING COIL LP TO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH THE COILS USING THE HANDLE; HOWEVER, THE RUBY COIL LP AND PACKING COIL LP FAILED TO DETACH. THEREFORE, THE PHYSICIAN REMOVED THE RUBY COIL LP AND PACKING COIL LP AND DETACHED ANOTHER RUBY COIL LP AND PACKING COIL LP IN THE TARGET VESSEL WITHOUT ISSUE. WHILE ATTEMPTING TO DETACH ANOTHER RUBY COIL LP IN A LARGER VESSEL, THE SAME ISSUE OCCURRED. THEREFORE, THE PHYSICIAN REMOVED THE RUBY COIL LP AND SUCCESSFULLY DETACHED ANOTHER RUBY COIL LP IN THE TARGET VESSEL WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12961033 ↗
• MalfunctionNov 22, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COIL LPS AND PACKING COIL LPS. DURING THE PROCEDURE, TWO RUBY COIL LPS AND TWO PACKING COIL LPS WOULD NOT ADVANCE AT ALL FROM THEIR INITIAL POSITION WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THE TWO RUBY COIL LPS AND TWO PACKING COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING 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 12850673 ↗
• MalfunctionNov 15, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PACKING COIL LP AND A MICROCATHETER. DURING THE PROCEDURE, THE PACKING COIL LP WAS UNABLE TO ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE PACKING COIL LP PUSHER WIRE KINKED. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PENUMBRA COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12817064 ↗
• MalfunctionNov 7, 2021Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE PACKING COIL LP OUT OF THE MICROCATHETER, IT WAS REPORTED THAT THE PACKING COIL LP BECAME STIFF AFTER THE COIL WAS HALF-WAY OUTSIDE AND WOULD NOT ADVANCE. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH THE NEXT PACKING COIL LP. THEREFORE, THE PACKING COIL LPS WERE REMOVED. IT WAS REPORTED THAT THE SALINE FLUSH WAS USED AFTER EVERY COIL WAS DEPLOYED. THE PROCEDURE WAS COMPLETED USING 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

  MAUDE report 12760120 ↗
• MalfunctionNov 7, 2021Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE PACKING COIL LP OUT OF THE MICROCATHETER, IT WAS REPORTED THAT THE PACKING COIL LP BECAME STIFF AFTER THE COIL WAS HALF-WAY OUTSIDE AND WOULD NOT ADVANCE. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH THE NEXT PACKING COIL LP. THEREFORE, THE PACKING COIL LPS WERE REMOVED. IT WAS REPORTED THAT THE SALINE FLUSH WAS USED AFTER EVERY COIL WAS DEPLOYED. THE PROCEDURE WAS COMPLETED USING 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

  MAUDE report 12760108 ↗
• 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 12619511 ↗
• MalfunctionSep 21, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY USING A PACKING COIL LP AND A MICROCATHETER. DURING THE PROCEDURE, THE PACKING COIL LP UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL LP WAS REMOVED FROM THE PATIENT. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510231 ↗
• MalfunctionAug 6, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (PAVM) USING RUBY COIL LPS AND PACKING COIL LPS. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE PAST ITS FRICTION LOCK WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED ANOTHER RUBY COIL LP IN THE TARGET VESSEL. NEXT, WHILE ATTEMPTING TO ADVANCE A PACKING COIL LP, IT WOULD NOT ADVANCE PAST ITS FRICTION LOCK WITHIN ITS INTRODUCER SHEATH AS WELL. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED ANOTHER PACKING COIL LP IN THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL LP COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12290445 ↗
• MalfunctionAug 3, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY BRANCH USING PACKING COIL LPS. DURING THE PROCEDURE, A PACKING COIL LP BECAME STUCK AND 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 12271636 ↗
• MalfunctionJul 16, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, AS THE PHYSICIAN WAS ADVANCING A PACKING COIL LP IN THE MICROCATHETER, THEY NOTICED THE MICROCATHETER MOVED. BEFORE THE PACKING COIL LP ADVANCED OUT OF THE MICROCATHETER, THE PHYSICIAN RESHEATHED IT TO ADJUST THE MICROCATHETER AND TAKE AN ANGIOGRAM. DURING ANGIOGRAM, THEY NOTICED THE PACKING COIL LP ADVANCING OUT OF THE MICROCATHETER. UPON INSPECTION OF THE PUSHER ASSEMBLY, THEY NOTICED THE DETACHMENT ZONE TO BE SEPARATED. THIS CAUSED THE PACKING COIL LP TO UNINTENTIONALLY DETACH IN THE SPLENIC ARTERY, MEDIAL TO THE ANEURYSM SACK. THE PROCEDURE WAS COMPLETED USING A 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 12186063 ↗
• MalfunctionJul 15, 2021Break; Unraveled Material; Physical Resistance/Sticking; Break; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID CAVERNOUS FISTULA (CCF) USING PENUMBRA SMART COILS (SMART COIL), A RUBY COIL LP, A PACKING COIL LP, A BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A BENCHMARK MAX IN THE RIGHT JUGULAR VEIN. THE PHYSICIAN THEN PLACED TWO SMART COILS INTO THE CAROTID CAVERNOUS SINUS USING THE MICROCATHETER. AFTERWARDS, A RUBY COIL LP AND A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS; THEREFORE, THE RUBY COIL LP AND THE SMART COIL WERE REMOVED. NEXT, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING APPROXIMATELY TEN CENTIMETERS OF A PACKING COIL LP THROUGH THE DISTAL END OF THE MICROCATHETER. SUBSEQUENTLY, WHILE ATTEMPTING TO RETRACT THE PACKING COIL LP, THE PHYSICIAN EXPERIENCED RESISTANCE AND HEARD A POPPING SOUND. THE PHYSICIAN THEN REMOVED THE PUSHER ASSEMBLY OF THE PACKING COIL LP AND NOTICED THE COIL BROKE AND UNRAVELED. AFTERWARDS, THE MICROCATHETER WAS REMOVED AND IT WAS NOTICED THAT THE REMAINING COIL WAS HANGING FROM THE HUB OF THE BENCHMARK MAX. SUBSEQUENTLY, WHILE THE PHYSICIAN ATTEMPTED TO PULL ON T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171167 ↗
• MalfunctionJul 13, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PACKING COIL LPS, RUBY COIL LPS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED MULTIPLE RUBY COIL LPS IN THE TARGET LOCATION USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE PACKING COIL LP THROUGH THE MICROCATHETER, THE PACKING COIL LP GOT STUCK IN THE MICROCATHETER AND WOULD NOT ADVANCE FURTHER. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING 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

  MAUDE report 12161027 ↗
• MalfunctionJun 16, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING PACKING COIL LPS. DURING THE PROCEDURE, TWO PACKING COIL LPS WOULD NOT ADVANCE WITHIN THEIR INTRODUCER SHEATHS; THEREFORE, THE PACKING COIL LPS WERE REMOVED. IT WAS REPORTED THAT THE FRICTION LOCKS OF THE PACKING COIL LPS WOULD NOT DISENGAGE. 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 12006449 ↗
• MalfunctionJun 16, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING PACKING COIL LPS. DURING THE PROCEDURE, TWO PACKING COIL LPS WOULD NOT ADVANCE WITHIN THEIR INTRODUCER SHEATHS; THEREFORE, THE PACKING COIL LPS WERE REMOVED. IT WAS REPORTED THAT THE FRICTION LOCKS OF THE PACKING COIL LPS WOULD NOT DISENGAGE. 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 12006448 ↗
• MalfunctionJun 11, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING PACKING COIL LPS AND RUBY COIL LPS. DURING THE PROCEDURE, ONE PACKING COIL LP AND TWO RUBY COIL LPS HAD FRICTION LOCKS THAT WOULD NOT DISENGAGE, AND THE COILS WOULD NOT ADVANCE IN THE INTRODUCER SHEATHS. THEREFORE, THE COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11986178 ↗
• MalfunctionJun 3, 2021Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PACKING COIL LPS, RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO POSITION THE PACKING COIL LP INTO THE TARGET LOCATION, THE PACKING COIL LP BROKE. THEREFORE, THE PACKING COIL LP WAS REMOVED. NEXT, WHILE THE PHYSICIAN ATTEMPTED TO ADVANCE A RUBY COIL LP WITHIN ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE RUBY COIL LP FROM THE STARTING POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP AND 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 11935536 ↗
• MalfunctionJun 1, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE INTO A HEART VESSEL 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. SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE PACKING COIL LP BECAME KINKED; THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER PACKING COIL LP; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE PACKING COIL LP WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PACKING COIL LPS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11916713 ↗
• MalfunctionJun 1, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE INTO A HEART VESSEL 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. SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE PACKING COIL LP BECAME KINKED; THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER PACKING COIL LP; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE PACKING COIL LP WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PACKING COIL LPS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11916704 ↗
• MalfunctionMay 19, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE II ENDOLEAK SAC IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COIL LPS, PACKING COIL LPS, LP SYSTEM DETACHMENT HANDLE (HANDLE), LANTERN DELIVERY MICROCATHETER (LANTERN), NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A LANTERN THROUGH THE DIAGNOSTIC CATHETER AND THE LANTERN BECAME STUCK. THE LANTERN WAS REMOVED AND A NEW MICROCATHETER WAS USED. THE PHYSICIAN THEN ATTEMPTED TO DETACH A FIRST PACKING COIL LP USING A HANDLE; HOWEVER, THE PACKING COIL LP FAILED TO DETACH. THE PHYSICIAN USED A NEW HANDLE; HOWEVER, THE PACKING COIL LP STILL FAILED TO DETACH. A HEMOSTAT WAS USED TO MANUALLY DETACH THE COIL. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A SECOND PACKING COIL LP; HOWEVER, THE PACKING COIL LP WOULD NOT ADVANCE PAST THE FRICTION LOCK WITHIN ITS INTRODUCER SHEATH. THE PHYSICIAN ATTEMPTED TO ADVANCE A THIRD PACKING COIL LP BUT, THE SAME ISSUE OCCURRED. A FOURTH PACKING COIL LP WAS ADVANCED TO THE TARGET LOCATION BUT HAD DIFFICULTY DETACHING. THEREFORE, THE PHYSICIAN USED A HEMOSTAT TO MANUALLY DETACH THE COIL. A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11848405 ↗