LP Coil System RBYPCLP10Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00815948021914), received between Apr 16, 2020 and Apr 21, 2023 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (27 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ARTERIAL COLLATERAL USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, AFTER ADVANCING A PACKING COIL LP INTO THE TARGET LOCATION, THE PHYSICIAN DECIDED TO RETRACT THE PACKING COIL LP TO REPOSITION IT WITHIN THE VESSEL. HOWEVER, WHILE RETRACTING THE COIL, THE PHYSICIAN NOTICED THE PACKING COIL LP HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL LP WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PHYSICIAN THEN REINSERTED THE MICROCATHETER BACK INTO THE PATIENT. THE PROCEDURE WAS COMPLETED USING 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 16792064 ↗
• 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 15254579 ↗
• 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 12800903 ↗
• MalfunctionOct 28, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING A PACKING COIL LP, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. 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 LP COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12716785 ↗
• MalfunctionOct 15, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE INSERTING A PACKING COIL LP INTO THE MICROCATHETER, THE PUSHER ASSEMBLY OF THE PACKING COIL LP KINKED. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PACKING COIL LP OF THE SAME 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 12643169 ↗
• 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 12639913 ↗
• MalfunctionOct 11, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING A PACKING COIL LP AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PACKING COIL LP WAS STUCK AND WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THE PHYSICIAN TRIED MULTIPLE TIMES TO ADVANCE OR RETRACT THE PACKING COIL LP; HOWEVER, THE PACKING COIL LP REMAINED STUCK. IT WAS REPORTED THAT THE SHEATH WAS STUCK TO THE PACKING COIL LP. THEREFORE, THE PACKING COIL LP 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 12610664 ↗
• MalfunctionSep 17, 2021Mechanical Problem; Separation Failure; Mechanical Problem; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PACKING COIL LPS AND A LP SYSTEM DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, A PACKING COIL LP WOULD NOT DETACH WITH THE HANDLE AFTER MULTIPLE ATTEMPTS. THEREFORE, THE PACKING COIL LP 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 12491902 ↗
• MalfunctionAug 17, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A PACKING COIL LP. DURING THE PROCEDURE, THE PACKING COIL LP WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. IT WAS REPORTED THAT MULTIPLE ATTEMPTS WERE MADE TO ADVANCE THE PACKING COIL LP; HOWEVER, THEY WERE UNSUCCESSFUL. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER LP COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12331977 ↗
• MalfunctionAug 13, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT GASTROINTESTINAL (GI) BLEEDING USING RUBY COILS, RUBY COIL LPS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO RUBY COIL LPS WOULD NOT ADVANCE OUT OF THE INTRODUCER SHEATHS. THEREFORE, THE RUBY COIL LPS 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 12321984 ↗
• MalfunctionJul 15, 2021Break; Failure to Advance; Break; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A COLIC BRANCH OFF THE SUPERFICIAL FEMORAL ARTERY (SFA) USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A PACKING COIL LP WOULD NOT ADVANCE PAST THE FRICTION LOCK WITHIN ITS INTRODUCER SHEATH; CONSEQUENTLY, THE PUSHER ASSEMBLY OF THE PACKING COIL LP BROKE. 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 12177441 ↗
• MalfunctionJul 14, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL BLEED USING A PACKING COIL LP, RUBY COIL LPS, NON-PENUMBRA COIL, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCED TWO RUBY COIL LPS INTO THE TARGET LOCATION; HOWEVER, BOTH RUBY COIL LPS WOULD NOT FORM AND STAY IN PLACE DUE TO THE HIGH FLOW OF THE VESSEL. THEREFORE, BOTH RUBY COIL LPS WERE REMOVED. SUBSEQUENTLY, THE PHYSICIAN PLACED A NON-PENUMBRA COIL AND WHEN ADVANCING A PACKING COIL LP THROUGH ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND, THE PUSHER ASSEMBLY OF THE PACKING COIL LP BECAME KINKED. THEREFORE, IT 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 12170938 ↗
• MalfunctionJun 29, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A PACKING COIL LP AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A PACKING COIL LP WOULD NOT ADVANCE PAST THE FRICTION LOCK 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 12089289 ↗
• MalfunctionJun 15, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING RUBY COIL LPS, PACKING COIL LPS, AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE RUBY COIL LP WOULD NOT ADVANCE FROM THE FRICTION LOCK WITHIN ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH THE OTHER RUBY COIL LP AND PACKING COIL LP. THEREFORE, THE RUBY COIL LPS AND PACKING COIL LP WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COIL LPS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12000379 ↗
• MalfunctionJun 8, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN AN AORTOPULMONARY (AP) COLLATERAL ARTERY 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 11958465 ↗
• MalfunctionApr 21, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GASTRIC ARTERY USING A PACKING COIL LP, RUBY COIL LPS, AND MICROCATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT A PACKING COIL LP AND TWO RUBY COIL LPS WAS UNABLE TO ADVANCE THROUGH THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING NEW PACKING COIL LPS AND RUBY COIL LPS. IT IS UNKNOWN IF THERE WAS ANY ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11699850 ↗
• MalfunctionMar 23, 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 NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL LP IN THE TARGET VESSEL USING THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO ADVANCE A PACKING COIL LP; HOWEVER, THE COIL WOULD NOT ADVANCE PAST THE FRICTION LOCK WITHIN THE INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. SUBSEQUENTLY, A NEW PACKING COIL LP WAS THEN PLACED IN THE VESSEL. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER PACKING COIL LP; HOWEVER, THE SAME ISSUE OCCURRED. 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 11558445 ↗
• MalfunctionMar 9, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING PACKING COIL LPS, RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A PACKING COIL LP WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THE PHYSICIAN MOVED THE PACKING COIL LP BACK AND FORTH IN AN ATTEMPT TO ADVANCE THE COIL WITHOUT SUCCESS. THEREFORE, THE PACKING COIL LP WAS REMOVED, AND ANOTHER PACKING COIL LP WAS SUCCESSFULLY IMPLANTED. LATER IN THE CASE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A RUBY COIL TO THE TARGET LOCATION AND SUBSEQUENTLY, IT DETACHED INSIDE THE LANTERN. THE RUBY COIL WAS THEN PULLED BACK AND REMOVED FROM THE LANTERN. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND THE SAME MICROCATHETERS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449152 ↗
• MalfunctionFeb 21, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING RUBY COIL LPS, PACKING COIL LPS, LP SYSTEM DETACHMENT HANDLE (HANDLE), AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED MULTIPLE RUBY COIL LPS IN THE TARGET VESSEL USING THE MICROCATHETER. SUBSEQUENTLY, TWO RUBY COIL LPS AND A PACKING COIL LP WOULD NOT ADVANCE PAST THE FRICTION LOCK WITHIN ITS INTRODUCER SHEATH ON THE BACK TABLE. THEREFORE, BOTH RUBY COIL LPS AND THE PACKING COIL LP WERE NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN ADVANCED A NEW PACKING COIL LP INTO THE VESSEL AND USED THE HANDLE TO DETACH IT; HOWEVER, THE PACKING COIL LP FAILED TO DETACH. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP WITH THE SAME HANDLE AND 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 11356623 ↗
• MalfunctionFeb 5, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING RUBY COIL LPS AND PACKING COIL LPS. DURING THE PROCEDURE, TWO RUBY COIL LPS AND THREE PACKING COIL LPS WOULD NOT ADVANCE AT ALL FROM THEIR INITIAL POSITIONS WITHIN THEIR INTRODUCER SHEATHS. THEREFORE, THE TWO RUBY COIL LPS AND THREE PACKING COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP AND NEW ADDITIONAL PACKING COIL LPS. 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 11288621 ↗
• MalfunctionJan 26, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTESTINAL BRANCH USING PACKING COIL LPS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A PACKING COIL LP WOULD NOT ADVANCE PAST THE FRICTION LOCK WITHIN ITS INTRODUCER SHEATH AND, THEREFORE, IT 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; No Consequences Or Impact To Patient

  MAUDE report 11229969 ↗
• MalfunctionDec 31, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A PACKING COIL LP FROM THE STARTING POSITION WITHIN THE INTRODUCER SHEATH. THEREFORE, THE PACKING COIL LP 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; No Consequences Or Impact To Patient

  MAUDE report 11100807 ↗
• MalfunctionDec 29, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC ARTERY USING PACKING COIL LPS AND A LP SYSTEM DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, UPON WORKING TO RELEASE A PACKING COIL LP FROM THE HANDLE, THE PACKING COIL LP WOULD NOT DETACH. IT WAS REPORTED THAT SEVERAL ATTEMPTS WERE MADE TO DETACH THE PACKING COIL LP, BUT THE PACKING COIL LP WOULD NOT FREE ITSELF FROM THE HANDLE. THEREFORE, THE PACKING COIL LP 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; No Consequences Or Impact To Patient

  MAUDE report 11088687 ↗
• MalfunctionDec 10, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR 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, IT WAS REMOVED. NEXT, THE SAME ISSUE OCCURRED WITH ANOTHER PACKING COIL LP. THEREFORE, THIS PACKING COIL LP WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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; No Consequences Or Impact To Patient

  MAUDE report 10985152 ↗
• MalfunctionNov 16, 2020Break; Failure to Advance; Physical Resistance/Sticking; Break; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING PACKING COIL LPS, RUBY COIL LPS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO PACKING COIL LPS, AND TWO RUBY COIL LPS WITHIN THE INTRODUCER SHEATHS AND EXPERIENCED RESISTANCE. UPON ATTEMPTING TO PULL BACK THE PACKING COIL LPS AND RUBY COIL LPS, THE PACKING COILS AND RUBY COIL LPS BROKE INSIDE THE INTRODUCER SHEATHS. THEREFORE, THE PACKING COIL LPS AND RUBY COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COIL LPS. 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 10848920 ↗