LP Coil System RBYPCLP30Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00815948021938), received between Mar 17, 2020 and Sep 6, 2024 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (11 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A PACKING COIL LP, A NON-PENUMBRA MICROCATHETER AND A BASE CATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE PACKING COIL LP THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE PHYSICIAN ATTEMPTED TO REMOVE THE PACKING COIL; HOWEVER, THE PACKING COIL LP WOULD NOT RETRACT AND UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL LP AND THE COIL WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING THREE 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 20163893 ↗
• MalfunctionAug 6, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT HEPATIC BRANCH ARTERY USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO NON-PENUMBRA COILS INTO THE TARGET LOCATION. AFTER ADVANCING A PACKING COIL LP INTO THE TARGET LOCATION, IT WAS REPORTED THAT THE COIL WOULD NOT TAKE ITS INTENDED SHAPE. THE PHYSICIAN RETRACTED THE PACKING COIL LP AND RE-ADVANCED IT INTO THE TARGET LOCATION; HOWEVER, THE ISSUE WAS UNRESOLVED. THE PHYSICIAN THEN DECIDED TO REMOVE THE PACKING COIL LP AND OBSERVED UNDER FLUOROSCOPY THAT THE COIL UNINTENTIONALLY DETACHED PARTIALLY IN THE PATIENT'S ANATOMY AND MOSTLY IN THE MICROCATHETER. THEREFORE, THE MICROCATHETER WAS REMOVED AND A SNARE DEVICE WAS THEN USED TO SUCCESSFULLY REMOVE THE DETACHED PACKING COIL LP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AT THIS POINT AND NO ADDITIONAL COILS WERE REQUIRED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19923348 ↗
• MalfunctionJul 22, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DISTAL HEPATIC BRANCH USING A PACKING COIL LP AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE LP COILS IN THE TARGET VESSEL. WHILE ADVANCING THE NEXT PACKING COIL LP INTO THE TARGET LOCATION, THE PHYSICIAN NOTICED THE MICROCATHETER KICKBACK OUT OF THE VESSEL. THEREFORE, THE PHYSICIAN DECIDED TO RESHEATH THE PACKING COIL LP. WHILE RESHEATHING THE PACKING COIL LP WITHIN THE MICROCATHETER, THE PACKING COIL LP UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL LP AND THE COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PACKING 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 19798203 ↗
• MalfunctionNov 10, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO RUBY COIL LPS. AFTER ADVANCING A PACKING COIL LP INTO THE TARGET LOCATION, THE PHYSICIAN REPORTED THAT THE COIL WAS NOT TAKING ITS INTENDED SHAPE AND FELT THAT THE PACKING COIL LP MIGHT HAVE BEEN TOO LONG. WHILE RETRACTING THE PACKING COIL LP, THE COIL UNINTENTIONALLY DETACHED WHEN IT WAS PARTIALLY IN THE VESSEL AND PARTIALLY IN THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE PACKING COIL LP. THE PROCEDURE WAS COMPLETED USING A SHORTER 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 18116730 ↗
• MalfunctionMay 24, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ENDOLEAK SACK USING PACKING COIL LPS, A LP SYSTEM DETACHMENT HANDLE (LP HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PACKING COIL LP THROUGH THE MICROCATHETER AND INTO THE TARGET VESSEL, THEN ATTEMPTED TO DETACH IT USING THE LP HANDLE; HOWEVER, THE PACKING COIL LP FAILED TO DETACH. NEXT, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE PACKING COIL LP, BUT THE COIL WOULD STILL NOT DETACH. THE PHYSICIAN THEN DECIDED TO REMOVE THE PACKING COIL LP. HOWEVER, WHILE RETRACTING THE PACKING COIL LP, IT UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEREFORE, THE PHYSICIAN FLUSHED THE DETACHED COIL INTO THE TARGET VESSEL. NEXT, THE PHYSICIAN ADVANCED A NEW PACKING COIL LP INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE LP HANDLE; HOWEVER, THE COIL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE PACKING COIL LP, BUT THE COIL WOULD STILL NOT DETACH. THEREFORE, THE PACKING COIL LP WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER PACKING COIL LP; THEREFORE, THE PACKING COIL LP WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ADDIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14489980 ↗
• MalfunctionApr 6, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CELIAC ANEURYSM USING A PACKING COIL LP, LP SYSTEM DETACHMENT HANDLES (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PACKING COIL LP AS THE FIRST COIL TO THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE PACKING COIL LP FAILED TO DETACH. THE PHYSICIAN THEN TRIED TO DETACH THE PACKING COIL LP USING ANOTHER HANDLE; HOWEVER, THE COIL STILL FAILED TO DETACH. THEN, THE PHYSICIAN ALSO TRIED TO MANUALLY DETACH THE PACKING COIL LP; HOWEVER, THE SAME ISSUE OCCURRED. SUBSEQUENTLY, WHILE RETRACTING THE PACKING COIL LP, THE COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL LP WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING RUBY COIL LPS, BOTH HANDLES, 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 14031706 ↗
• MalfunctionApr 5, 2022Migration; Premature Separation; Migration; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) TO TREAT A GASTROINTESTINAL (GI) BLEED USING PACKING COIL LPS, RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL LP IN THE TARGET LOCATION USING THE MICROCATHETER. NEXT, WHILE ATTEMPTING TO ADVANCE THE PACKING COIL LP, THE PHYSICIAN FELT THE PACKING COIL LP TO BE STIFF AND KICKING BACK AND WAS UNABLE TO PACK IT IN THE TARGET VESSEL. SUBSEQUENTLY, THE PACKING COIL LP UNINTENTIONALLY DETACHED, AND THE PHYSICIAN TRIED TO PUSH THE PACKING COIL LP USING THE PUSHER ASSEMBLY; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. THE PACKING COIL LP THEN DISLODGED THE PREVIOUSLY PLACED RUBY COIL LP AND THE RUBY COIL LP MIGRATED INTO A SMALL VESSEL IN THE SUPERIOR MESENTERIC ARTERY. THE PACKING COIL LP WAS LEFT PARTIALLY IN THE TARGET VESSEL AND PARTIALLY IN THE COMMON HEPATIC ARTERY. ATTEMPTS WERE MADE TO RETRIEVE THE PACKING COIL LP AND RUBY COIL LP BY USING A SNARE DEVICE WITHOUT SUCCESS. THE PHYSICIAN ALSO TRIED USING A BALLOON TO PUSH THE COILS INTO THE TARGET VESSEL; HOWEVER, IT WAS UNSUCCESSFUL. IT WAS REPORTED THAT THE BLEEDING HAD STOPPED, AND NO ADDITIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14018080 ↗
• 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 13635230 ↗
• 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 13635132 ↗
• MalfunctionJan 13, 2022Break; Unraveled Material; Physical Resistance/Sticking; Break; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CELIAC GASTROINTESTINAL BLEED (GI BLEED) USING PACKING COIL LP AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PACKING COIL LP PARTIALLY INTO THE TARGET LOCATION AND DETERMINED THE COIL TO BE TOO LONG FOR THE VESSEL. IT WAS REPORTED THAT THE PACKING COIL LP HAD NOT FULLY EXITED THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO REMOVE THE PACKING COIL LP; HOWEVER, UPON RETRACTING THE PACKING COIL LP, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PACKING COIL LP BROKE OFF AND STARTED TO UNRAVEL WITHIN THE MICROCATHETER WHILE PARTIALLY INSIDE THE TARGET VESSEL. IT WAS ALSO REPORTED THAT THE PACKING COIL LP HAD NOT DETACHED FROM THE PUSHER ASSEMBLY. THEREFORE, THE PHYSICIAN FLUSHED THE MICROCATHETER TO PUSH THE BROKEN PORTION OF THE PACKING COIL LP INTO THE VESSEL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PACKING 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 13253075 ↗
• MalfunctionDec 5, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING A PACKING COIL LP, RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE PACKING COIL LP INTO THE MICROCATHETER, THE HOSPITAL TECHNOLOGIST HAND WAS HOLDING THE COIL AT THE STARTING POSITION OF THE INTRODUCER SHEATH AND, CONSEQUENTLY, THE PUSHER ASSEMBLY OF THE PACKING COIL LP BECAME BENT. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE HOSPITAL TECHNOLOGIST THEN ATTEMPTED TO ADVANCE TWO RUBY COIL LPS INTO THE MICROCATHETER; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL LP COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12931060 ↗
• MalfunctionDec 2, 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. DURING THE PROCEDURE, A PACKING COIL LP WOULD NOT ADVANCE FROM THE STARTING 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 12920837 ↗
• MalfunctionNov 19, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE), PENUMBRA SMART COILS (SMART COIL), PACKING COIL LPS, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DETACHED A SMART COIL IN THE TARGET VESSEL USING A HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN SUCCESSFULLY DETACHED A PACKING COIL LP IN THE TARGET VESSEL USING A SECOND HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER PACKING COIL LP TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE PACKING COIL LP ALSO FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. THEREFORE, THE PACKING COIL LP WAS REMOVED. THEN, THE SAME ISSUE OCCURRED WITH ANOTHER PACKING COIL LP. IT WAS REPORTED THAT A SECOND ATTEMPT MADE TO DETACH THE PACKING COIL LP WITH THE FIRST HANDLE WAS ALSO UNSUCCESSFUL. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE PACKING COIL LP. THE PROCEDURE WAS COMPLETED AT THIS POINT AS THE PHYSICI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12841366 ↗
• MalfunctionNov 19, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE), PENUMBRA SMART COILS (SMART COIL), PACKING COIL LPS, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DETACHED A SMART COIL IN THE TARGET VESSEL USING A HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN SUCCESSFULLY DETACHED A PACKING COIL LP IN THE TARGET VESSEL USING A SECOND HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER PACKING COIL LP TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE PACKING COIL LP ALSO FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. THEREFORE, THE PACKING COIL LP WAS REMOVED. THEN, THE SAME ISSUE OCCURRED WITH ANOTHER PACKING COIL LP. IT WAS REPORTED THAT A SECOND ATTEMPT MADE TO DETACH THE PACKING COIL LP WITH THE FIRST HANDLE WAS ALSO UNSUCCESSFUL. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE PACKING COIL LP. THE PROCEDURE WAS COMPLETED AT THIS POINT AS THE PHYSICI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12841353 ↗
• MalfunctionOct 31, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) AND INFERIOR MESENTERIC ARTERY (IMA) ENDOLEAK SAC USING PACKING COIL LPS, RUBY COIL LPS, A LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PACKING COIL LP INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE PACKING COIL LP FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE PACKING COIL LP USING A HEMOSTAT, BUT THE COIL STILL WOULD NOT DETACH. THEREFORE, THE PACKING COIL LP WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO DETACH TWO RUBY COIL LPS IN THE TARGET LOCATION USING THE SAME HANDLE. THEREFORE, THE HANDLE WAS REMOVED. THE PHYSICIAN ATTEMPTED TO DETACH THE SAME RUBY COILS USING A NEW HANDLE, BUT THE TWO RUBY COIL LPS WOULD NOT DETACH. IT WAS ALSO REPORTED THAT THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE TWO RUBY COIL LPS USING A HEMOSTAT; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. THEREFORE, THE TWO RUBY COIL LPS AND HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW LP COILS WITH A HEMOSTAT AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12725690 ↗
• MalfunctionOct 30, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PACKING COIL LPS. DURING THE PROCEDURE, THE PACKING COIL LP WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH INTO THE MICROCATHETER. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A RUBY COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12724919 ↗
• 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 12619510 ↗
• 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 12619499 ↗
• MalfunctionSep 16, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING PACKING COIL LPS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE THE PUSHER ASSEMBLIES OF TWO PACKING COIL LPS THROUGH THE INTRODUCER SHEATHS, BUT THE TENSION LOCKS WERE TIGHT, WHICH CAUSED THE PUSHER ASSEMBLIES TO KINK. THEREFORE, THE PACKING COIL LPS WERE 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 12483055 ↗
• MalfunctionSep 16, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING PACKING COIL LPS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE THE PUSHER ASSEMBLIES OF TWO PACKING COIL LPS THROUGH THE INTRODUCER SHEATHS, BUT THE TENSION LOCKS WERE TIGHT, WHICH CAUSED THE PUSHER ASSEMBLIES TO KINK. THEREFORE, THE PACKING COIL LPS WERE 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 12481513 ↗
• MalfunctionSep 11, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ARTERIAL PULMONARY COLLATERAL ARTERY USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PACKING COIL LP WOULD NOT ADVANCE AT ALL FROM ITS INITIAL POSITION WITHIN THE INTRODUCER SHEATH. IT WAS ALSO REPORTED THAT THE TECHNICIAN ATTEMPTED TO ADVANCE THE PACKING COIL LP THROUGH THE INTRODUCER SHEATH ON THE BACK TABLE WITH FINGERS PROXIMAL AND DISTAL TO THE FRICTION LOCK; HOWEVER, IT WAS UNSUCCESSFUL. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A RUBY COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457574 ↗
• MalfunctionSep 1, 2021Failure to Fold; Physical Resistance/Sticking; Failure to Fold; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROSTATE ARTERY USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PACKING COIL LP WOULD NOT TAKE ITS INTENDED SHAPE WITHIN THE TARGET VESSEL. THE PACKING COIL LP WAS STRAIGHT AND WAS NOT COILING. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE PACKING COIL LP INTO THE TARGET VESSEL. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 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 12411382 ↗
• MalfunctionAug 26, 2021Failure to Fold; Physical Resistance/Sticking; Failure to Fold; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROSTATE ARTERY USING PACKING COIL LPS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A PACKING COIL LP WOULD NOT TAKE ITS INTENDED SHAPE. IT WAS REPORTED THAT THE PACKING COIL LP WAS STRAIGHT AND WAS NOT COILING AS IT SHOULD. IT WAS ALSO REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE PACKING COIL LP INTO THE VESSEL. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO NEW LP COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12371411 ↗
• MalfunctionAug 18, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COLLATERAL VESSELS USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE PACKING COIL LP THROUGH ITS INTRODUCER SHEATH TOWARD THE MICROCATHETER. THE PACKING COIL LP WAS RETRACTED BACK INTO ITS INTRODUCER SHEATH AND SUBSEQUENTLY REMOVED. THE MICROCATHETER WAS FLUSHED AND THE PACKING COIL LP WAS PLACED INTO A BOWL OF SALINE WHERE IT WAS ABLE TO PARTIALLY DEPLOY WITHOUT RESISTANCE. WHILE MAKING THE SECOND ATTEMPT TO ADVANCE THE PACKING COIL LP INTO THE MICROCATHETER, RESISTANCE WAS AGAIN ENCOUNTERED WITHIN THE INTRODUCER SHEATH. THEREFORE, THE PACKING COIL LP WAS REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. 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 12339052 ↗
• MalfunctionJul 15, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COLIC ARTERY USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PACKING COIL LP THROUGH THE MICROCATHETER AND INTO THE TARGET VESSEL. HOWEVER, THE PHYSICIAN WAS NOT SATISFIED WITH THE PLACEMENT OF THE PACKING COIL LP; THEREFORE, THE PHYSICIAN RETRACTED THE PACKING COIL LP AND REPOSITIONED THE MICROCATHETER. SUBSEQUENTLY, WHILE ATTEMPTING TO RE-ADVANCE THE SAME PACKING COIL LP, THE PHYSICIAN NOTICED THE PACKING COIL LP WAS 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 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 12178269 ↗