LP Coil System RBYPCLP06Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00815948021907), received between Aug 11, 2020 and Jun 12, 2026 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (19 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PACKING COIL LPS, A LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA TAPERED MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S VESSEL WAS TORTUOUS. A PACKING COIL LP WAS ADVANCED THROUGH THE MICROCATHETER INTO THE TARGET VESSEL; HOWEVER, THE PACKING COIL LP FAILED TO DETACH USING THE HANDLE. THE PHYSICIAN DECIDED TO REMOVE AND RESHEATH THE PACKING COIL LP. WHILE ATTEMPTING TO REMOVE THE PACKING COIL LP, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PACKING COIL LP PUSHER ASSEMBLY WAS THEN USED TO PUSH THE EMBOLIZATION COIL INTO THE TARGET LOCATION. THE SAME ISSUE OCCURRED WITH TWO ADDITIONAL PACKING COIL LPS. BOTH EMBOLIZATION COILS WERE ALSO PUSHED INTO THE TARGET LOCATION USING THEIR PUSHER ASSEMBLIES. THE PROCEDURE WAS COMPLETED USING SEVEN NON-PENUMBRA DETACHABLE 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 25487038 ↗
• MalfunctionNov 27, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A PACKING COIL LP AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE PACKING COIL LP, BUT THE PACKING COIL LP WOULD NOT DETACH. THE PHYSICIAN DECIDED TO REMOVE THE PACKING COIL LP. WHILE REMOVING THE PACKING COIL LP, THE PACKING COIL LP UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A 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 20800124 ↗
• 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 12741118 ↗
• MalfunctionAug 26, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RETROPERITONEAL BLEED USING PACKING COIL LP AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A PACKING COIL LP AS THE FIRST COIL THROUGH THE MICROCATHETER, THE PACKING COIL LP HAD UNINTENTIONALLY DETACHED EARLY IN THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN USED THE PUSHER ASSEMBLY TO PUSH THE DETACHED PACKING COIL LP INTO THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12374941 ↗
• MalfunctionAug 19, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A COLLATERAL OF THE INTERNAL ILIAC ARTERY USING PACKING COIL LPS, RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLES (HANDLE), A NON-PENUMBRA COIL , A NON-PENUMBRA MICROCATHETER AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS VERY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PACKING COIL LP INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE. HOWEVER, THE PACKING COIL LP FAILED TO DETACH. THEREFORE, THE PACKING COIL LP WAS RETRACTED AND REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH ANOTHER PACKING COIL LP. THEREFORE, THE PACKING COIL LP WAS ALSO REMOVED. THEN, THE PHYSICIAN ADVANCED THE NEXT PACKING COIL LP INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE PACKING COIL LP FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE PACKING COIL LP USING A SURGICAL CLAMP. NEXT, THE PHYSICIAN SUCCESSFULLY IMPLANTED A NON-PENUMBRA COIL IN THE TARGET VESSEL. THE PHYSICIAN THEN ADVANCED A RUBY COIL LP INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A SECOND HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE PH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12344001 ↗
• MalfunctionAug 19, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A COLLATERAL OF THE INTERNAL ILIAC ARTERY USING PACKING COIL LPS, RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLES (HANDLE), A NON-PENUMBRA COIL , A NON-PENUMBRA MICROCATHETER AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS VERY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PACKING COIL LP INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE. HOWEVER, THE PACKING COIL LP FAILED TO DETACH. THEREFORE, THE PACKING COIL LP WAS RETRACTED AND REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH ANOTHER PACKING COIL LP. THEREFORE, THE PACKING COIL LP WAS ALSO REMOVED. THEN, THE PHYSICIAN ADVANCED THE NEXT PACKING COIL LP INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE PACKING COIL LP FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE PACKING COIL LP USING A SURGICAL CLAMP. NEXT, THE PHYSICIAN SUCCESSFULLY IMPLANTED A NON-PENUMBRA COIL IN THE TARGET VESSEL. THE PHYSICIAN THEN ADVANCED A RUBY COIL LP INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A SECOND HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE PH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12343981 ↗
• MalfunctionAug 13, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) USING PACKING COIL LPS, A LP SYSTEM DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DETACH THREE PACKING COIL LPS USING THE HANDLE; HOWEVER, ALL THREE PACKING COIL LPS FAILED TO DETACH. THE PHYSICIAN ALSO TRIED USING ANOTHER HANDLE BUT WAS UNSUCCESSFUL. AFTERWARDS, THE PHYSICIAN WAS ABLE TO MANUALLY DETACH THE PACKING COIL LPS AFTER MULTIPLE ATTEMPTS. IT WAS REPORTED THAT THE FIRST HANDLE WORKED FINE WHILE PERFORMING A CLICK TEST; HOWEVER, WHILE TRYING TO DETACH THE COIL, THE HANDLE WOULD ONLY HALF CLICK AND SLOWLY RETURN TO ITS ORIGINAL POSITION WITHOUT DETACHING THE COIL. THE PROCEDURE WAS COMPLETED USING FIVE ADDITIONAL PACKING COIL LPS AND THE SECOND HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12321319 ↗
• MalfunctionAug 13, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) USING PACKING COIL LPS, A LP SYSTEM DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DETACH THREE PACKING COIL LPS USING THE HANDLE; HOWEVER, ALL THREE PACKING COIL LPS FAILED TO DETACH. THE PHYSICIAN ALSO TRIED USING ANOTHER HANDLE BUT WAS UNSUCCESSFUL. AFTERWARDS, THE PHYSICIAN WAS ABLE TO MANUALLY DETACH THE PACKING COIL LPS AFTER MULTIPLE ATTEMPTS. IT WAS REPORTED THAT THE FIRST HANDLE WORKED FINE WHILE PERFORMING A CLICK TEST; HOWEVER, WHILE TRYING TO DETACH THE COIL, THE HANDLE WOULD ONLY HALF CLICK AND SLOWLY RETURN TO ITS ORIGINAL POSITION WITHOUT DETACHING THE COIL. THE PROCEDURE WAS COMPLETED USING FIVE ADDITIONAL PACKING COIL LPS AND THE SECOND HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12321312 ↗
• MalfunctionAug 2, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE SPLENIC ARTERY USING PACKING COIL LPS AND RUBY COIL LPS. DURING THE PROCEDURE, A PACKING COIL LP AND RUBY COIL LP WOULD NOT ADVANCE FROM THE STARTING POSITION OF THEIR INTRODUCER SHEATHS. THEREFORE, THE COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING PENUMBRA AND OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12257715 ↗
• MalfunctionJul 14, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING PACKING COIL LPS. 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 LP COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171002 ↗
• MalfunctionJul 9, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING PACKING COIL LPS. DURING THE PROCEDURE, TWO PACKING COIL LPS WOULD NOT ADVANCE PAST THEIR FRICTION LOCKS. THE PHYSICIAN ATTEMPTED TO TROUBLESHOOT BY PINCHING THE DISTAL END OF THE FRICTION LOCKS, BUT WAS UNSUCCESSFUL. THEREFORE, THE PACKING COIL LPS WERE 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 12145610 ↗
• MalfunctionJul 9, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING PACKING COIL LPS. DURING THE PROCEDURE, TWO PACKING COIL LPS WOULD NOT ADVANCE PAST THEIR FRICTION LOCKS. THE PHYSICIAN ATTEMPTED TO TROUBLESHOOT BY PINCHING THE DISTAL END OF THE FRICTION LOCKS, BUT WAS UNSUCCESSFUL. THEREFORE, THE PACKING COIL LPS WERE 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 12145601 ↗
• MalfunctionMay 7, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING A PACKING COIL LP. DURING THE PROCEDURE, A PACKING COIL LP WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT 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 11794328 ↗
• MalfunctionApr 28, 2021Separation Failure; Difficult to Advance; Physical Resistance/Sticking; Separation Failure; Difficult to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A TRANS-ARTERIAL COIL EMBOLIZATION PROCEDURE FROM THE SUPERIOR MESENTERIC ARTERY (SMA) TO THE INFERIOR MESENTERIC ARTERY (IMA) USING PACKING COIL LPS, RUBY COIL LPS, PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT HAD POSSIBLE STENOSIS AND NARROWED VESSELS. DURING THE PROCEDURE, WHILE ATTEMPTING TO IMPLANT THE PACKING COIL LP AS THE FIRST COIL, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE COIL THROUGH THE MICROCATHETER. AFTER POSITIONING THE PACKING COIL LP IN THE TARGET LOCATION, THE COIL COULD NOT BE DETACHED USING THE HANDLE. IT WAS ALSO REPORTED THAT SEVERAL ATTEMPTS TO MANUALLY DETACH THE COIL FAILED; THEREFORE, THE PACKING COIL LP WAS REMOVED. WHILE ADVANCING A 2X4 RUBY COIL LP (F102505) THROUGH THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE RUBY COIL LP WOULD NOT ADVANCE BEYOND THE DISTAL END OF THE MICROCATHETER. THEREFORE, THE RUBY COIL LP WAS REMOVED. NEXT, THE PHYSICIAN ATTEMPTED TO USE A SMART COIL WHICH HAD A SMALLER DIAMETER THAN THE PREVIOUS COILS. HOWEVER, RESISTANCE WAS ALSO ENCOUNTERED WHILE ADVANCING THE SMART C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11739937 ↗
• 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 11558447 ↗
• MalfunctionMar 2, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE THORACIC DUCT USING A 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 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 11402014 ↗
• MalfunctionFeb 16, 2021Separation Failure; Material Twisted/Bent; Separation Failure; Material Twisted/Bent

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT THE RENAL BLEED USING PACKING COIL LPS, RUBY COIL LPS, A NON-PENUMBRA MICROCATHETER, AND LP SYSTEM DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE MICROCATHETER WAS ADVANCED TO THE RENAL BLEED/ BRANCH AND RUBY COIL LPS WERE SUCCESSFULLY IMPLANTED. SUBSEQUENTLY, A PACKING COIL LP WOULD NOT DETACH, AND THE PUSHER ASSEMBLY OF THE COIL HAD BENT. 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 11331543 ↗
• MalfunctionFeb 3, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DISTAL BRANCH OF THE INFERIOR MESENTERIC ARTERY (IMA) USING PACKING COIL LPS AND A MICROCATHETER. DURING THE PROCEDURE, A PACKING COIL LP WOULD NOT ADVANCE BEYOND THE FRICTION LOCK. AFTER PULLING BACK ON THE PUSHER ASSEMBLY AND THEN ATTEMPTING TO RE-ADVANCE THE PACKING COIL LP INTO THE MICROCATHETER, THE PACKING COIL LP WOULD NOT MOVE FORWARD. 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; No Consequences Or Impact To Patient

  MAUDE report 11276499 ↗
• MalfunctionJan 9, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS LP, A PACKING COIL LP AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO RUBY COILS LP IN THE TARGET VESSEL USING THE MICROCATHETER. NEXT, A PACKING COIL LP WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH AND AFTERWARDS, ATTEMPTS WERE MADE TO PUSH AND PULL THE PACKING COIL LP. SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE PACKING COIL LP KINKED. THEREFORE, THE PACKING COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL LP AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 11143579 ↗
• MalfunctionDec 29, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) 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 AND, 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; No Consequences Or Impact To Patient

  MAUDE report 11088445 ↗
• 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 10985113 ↗
• MalfunctionDec 1, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED A RUBY COIL LP IN THE TARGET VESSEL. NEXT, WHILE ATTEMPTING TO ADVANCE THE PACKING COIL LP PAST ITS INITIAL POSITION IN ITS INTRODUCER SHEATH, THE PUSHER ASSEMBLY BECAME KINKED. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING FOUR 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; No Consequences Or Impact To Patient

  MAUDE report 10929127 ↗
• MalfunctionOct 15, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COLLATERAL ARTERIES USING PACKING COIL LPS. DURING THE PROCEDURE, A PACKING COIL LP MOVED SLIGHTLY BUT WOULD NOT ADVANCE OUT OF THE INTRODUCER SHEATH. THEREFORE, IT 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; No Consequences Or Impact To Patient

  MAUDE report 10687106 ↗
• MalfunctionOct 1, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT GASTRIC ARTERY USING PACKING COIL LPS. DURING THE PROCEDURE, A PACKING COIL LP WOULD NOT ADVANCE IN THE INTRODUCER SHEATH, AND THE FRICTION LOCK WOULD NOT BREAK. SUBSEQUENTLY, THE PACKING COIL LP WAS REMOVED. THE PHYSICIAN CONTINUED WITH THE PROCEDURE USING ANOTHER PACKING COIL LP, AND THE SAME ISSUE OCCURRED TO THE PACKING COIL LP. THEREFORE, THE PACKING COIL LP WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER LP COILS. 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 10617934 ↗
• MalfunctionOct 1, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT GASTRIC ARTERY USING PACKING COIL LPS. DURING THE PROCEDURE, A PACKING COIL LP WOULD NOT ADVANCE IN THE INTRODUCER SHEATH, AND THE FRICTION LOCK WOULD NOT BREAK. SUBSEQUENTLY, THE PACKING COIL LP WAS REMOVED. THE PHYSICIAN CONTINUED WITH THE PROCEDURE USING ANOTHER PACKING COIL LP, AND THE SAME ISSUE OCCURRED TO THE PACKING COIL LP. THEREFORE, THE PACKING COIL LP WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER LP COILS. 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 10617897 ↗