POD RBYPOD5-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00814548019604), received between Nov 2, 2018 and Jan 29, 2025 — classified as 35 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (23 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS, RUBY COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED SIX RUBY COILS, AND ONE POD COIL. WHILE ADVANCING THE NEXT POD COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE POD COIL HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW POD 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 21264695 ↗
• MalfunctionAug 27, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A POD COIL. DURING THE PROCEDURE, WHILE INSERTING THE POD COIL INTO THE LANTERN, THE POD COIL FELT SLOW TO ADVANCE AND THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE POD COIL AND FOUND THAT THE POD COIL HAD UNINTENTIONALLY DETACHED WITHIN THE PROXIMAL LENGTH OF THE LANTERN. THEREFORE, THE POD COIL WAS REMOVED. IT WAS REPORTED THAT THE POD COIL WAS FLUSHED OUT OF THE LANTERN. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL, A POD PACKING COIL (PACKING COIL), AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20081764 ↗
• MalfunctionJul 24, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A POD COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE LANTERN, THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE PHYSICIAN ATTEMPTED TO PUSH THE DETACHED POD COIL OUT OF THE LANTERN USING ITS PUSHER ASSEMBLY AND ATTEMPTED TO FLUSH THE POD COIL OUT OF THE LANTERN, BUT WAS UNSUCCESSFUL. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED. IT WAS REPORTED THAT THE POD COIL WAS FLUSHED OUT OF THE LANTERN ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL POD COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822923 ↗
• MalfunctionJun 5, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A POD COIL, A NON-PENUMBRA MICROCATHETER, AND AN ANGIOGRAPHIC CATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE POD COIL INTO THE TARGET VESSEL USING THE MICROCATHETER. HOWEVER, THE POD COIL WAS NOT TAKING IT¿S INTENDED SHAPE. AFTER MULTIPLE ATTEMPTS TO RETRACT AND RE-ADVANCE THE POD COIL AGAINST RESISTANCE, THE PHYSICIAN FELT AND NOTICED UNDER ANGIOGRAM THAT THE POD COIL HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE POD COIL WAS REMOVED. THE PROCEDURE WAS COMPETED USING A NEW POD COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17065444 ↗
• MalfunctionJan 26, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE TARGET VESSEL OF THE PATIENT WAS CLAMPED. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE LANTERN TOO CLOSE TO THE CLAMP. SUBSEQUENTLY, THE POD COIL WAS ADVANCED AND PUSHED THROUGH THE CLAMP; HOWEVER, THE POD COIL WOULD NOT FORM AND REMAINED STRAIGHT IN THE VESSEL. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE POD COIL. WHILE RETRACTING THE POD COIL, THE PHYSICIAN ENCOUNTERED RESISTANCE AND SUBSEQUENTLY, THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL AND THE SAME LANTERN. IT WAS REPORTED THAT THE SECOND TIME THE LANTERN WAS POSITIONED LITTLE AWAY FROM THE CLAMP AND THE PHYSICIAN WAS ABLE TO ADVANCE THE POD COIL WITHOUT ANY ISSUES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16246529 ↗
• MalfunctionJan 9, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE FIRST POD COIL THROUGH THE MIDDLE OF THE LANTERN. UPON RETRACTION, THE POD COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED FROM THE PATIENT, AND THE POD COIL WAS FLUSHED OUT FROM THE LANTERN ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN AND A NEW POD COIL OF THE SAME SIZE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16124291 ↗
• MalfunctionJun 2, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING POD COILS AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE NON-PENUMBRA COILS INTO THE DISTAL TARGET SITE. AFTER ADVANCING A POD COIL INTO THE PROXIMAL TARGET SITE, THE PHYSICIAN REPORTED THAT THE COIL WOULD NOT TAKE THE DESIRED SHAPE. THEREFORE, THE POD COIL WAS REMOVED. AFTER FLUSHING THE MICROCATHETER, THE POD COIL WAS RE-INSERTED AND BECAME STUCK IN THE MIDDLE OF THE MICROCATHETER. WHILE ATTEMPTING TO MOVE THE POD COIL, RESISTANCE WAS ENCOUNTERED AND THE POD COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER WHEN THE DISTAL END OF THE COIL WAS IN THE MIDDLE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL 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 14580252 ↗
• MalfunctionNov 24, 2021Failure to Fold; Physical Resistance/Sticking; Failure to Fold; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY USING POD COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NON-PENUMBRA CATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A POD COIL IN THE TARGET LOCATION USING THE LANTERN. THE PHYSICIAN THEN ADVANCED THE NEXT POD COIL INTO THE TARGET LOCATION, BUT IT WOULD NOT TAKE ITS INTENDED SHAPE. THE PHYSICIAN MADE SEVERAL ATTEMPTS TO RETRACT AND REPOSITION THE POD COIL AND LANTERN. SUBSEQUENTLY, IN ONE OF THE ATTEMPTS, THE POD COIL BECAME STUCK AT THE DISTAL END OF THE LANTERN. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE USING THE POD COIL. THEREFORE, THE POD COIL AND LANTERN WERE REMOVED TOGETHER. THE PROCEDURE ENDED AT THIS POINT AFTER THE PHYSICIAN CONFIRMED THAT THE COIL EMBOLIZATION WAS ACHIEVED WITH THE POD COIL THAT WAS PREVIOUSLY IMPLANTED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12871424 ↗
• MalfunctionOct 21, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A POD5 TO THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN NOTICED THAT THE POD5 WAS TOO SMALL; THEREFORE, THE POD5 WAS RE-SHEATHED. THE PHYSICIAN THEN ATTEMPTED TO USE A POD6 BUT NOTICED IT WAS TOO BIG; THEREFORE, THE POD6 WAS REMOVED. NEXT, THE PHYSICIAN DECIDED TO RE-USE THE PREVIOUSLY RE-SHEATHED POD5 AND PLACED IT FURTHER DOWN THE VESSEL. WHILE ADVANCING THE POD5, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, WHILE PLACING THE POD5 IN THE TARGET LOCATION, THE LANTERN KICKED BACK IN THE VESSEL. THE PHYSICIAN THEN DECIDED TO RETRACT THE POD5 SO THAT THE LANTERN CAN BE ADVANCED FURTHER DOWN THE VESSEL. WHILE RETRACTING THE POD5, IT UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE PHYSICIAN USED THE PUSHER ASSEMBLY OF THE POD5 TO SUCCESSFULLY PUSH THE DETACHED POD5 INTO THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING SEVEN RUBY COILS, THREE POD PACKING COILS, ONE POD COIL AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12674766 ↗
• MalfunctionSep 21, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING POD COILS AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE FIRST POD COIL DID NOT FIT INTO THE TARGET LOCATION AFTER SEVERAL ATTEMPTS WERE MADE. WHILE RETRIEVING THE POD COIL, THE PHYSICIAN NOTICED THE COIL DID NOT FOLLOW THE MOVEMENTS OF THE PUSHER ASSEMBLY AND FOUND THAT IT HAD DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER, ONE RUBY COIL, AND TWO POD PACKING COILS (POD PCS). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510246 ↗
• MalfunctionSep 3, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERY USING A POD COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD COIL INTO THE TARGET LOCATION USING THE LANTERN. THE PHYSICIAN THEN EXPERIENCED RESISTANCE AFTER FORMING ONE LOOP WITH THE POD COIL INTO THE TARGET LOCATION. SUBSEQUENTLY, WHILE FORMING APPROXIMATELY FOUR LOOPS WITH THE POD COIL, THE PHYSICIAN FELT AS IF THE POD COIL HAD DETACHED. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE POD COIL. HOWEVER, WHILE ATTEMPTING TO RETRACT THE POD COIL, THE PHYSICIAN NOTICED THAT THE POD COIL HAD UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED POD COIL FROM THE PATIENT AND THEN REMOVED THE POD COIL FROM THE LANTERN ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING FOUR RUBY COILS, FIVE POD PACKING COILS (POD PCS), AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422176 ↗
• MalfunctionAug 27, 2021Physical Resistance/Sticking; Difficult or Delayed Separation; Physical Resistance/Sticking; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A RUBY COIL DETACHMENT HANDLE (HANDLE), POD COILS, A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA CATHETER, AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD COIL INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE POD COIL FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. IT WAS REPORTED THAT THE COIL ALIGNMENT ZONE SEPARATED, BUT THE POD COIL DID NOT DETACH. THEREFORE, THE PHYSICIAN PULLED THE PUSHER ASSEMBLY OF THE POD COIL WITH THE HANDLE TO DETACH IT. IT WAS ALSO REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE INSERTING THE PROXIMAL END OF THE PUSHER ASSEMBLY INTO THE HANDLE. NEXT, THE PHYSICIAN ADVANCED ANOTHER POD COIL TO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE PHYSICIAN ALSO PULLED THE PUSHER ASSEMBLY OF THE POD COIL WITH THE HANDLE TO DETACH IT. THE PROCEDURE WAS COMPLETED USING ANOTHER HANDLE AND EIGHT ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12375952 ↗
• MalfunctionAug 4, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A POD COIL INTO THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD COIL WOULD NOT ADVANCE. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL AND THE SAME LANTERN. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12276392 ↗
• MalfunctionMay 21, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A POD8 COIL THROUGH THE MIDDLE OF THE MICROCATHETER. THEREFORE, THE POD8 WAS REMOVED FROM THE MICROCATHETER AND SET SIDE. NEXT, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A POD5 THROUGH THE SAME PLACE IN THE MICROCATHETER; THEREFORE, THE POD5 WAS REMOVED AND SET ASIDE. THE SAME ISSUE OCCURRED WITH A POD6; THEREFORE, THE POD6 WAS ALSO REMOVED AND SET ASIDE. THE PHYSICIAN EXCHANGED THE MICROCATHETER FOR A LANTERN DELIVERY MICROCATHETER (LANTERN) AND PROCEEDED TO RE-ADVANCE THE SAME POD5 AND POD6. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHILE ADVANCING BOTH THE POD5 AND THE POD6; HOWEVER, THE COILS WERE SUCCESSFULLY IMPLANTED. WHILE ADVANCING THE SAME POD8 THROUGH THE LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE. THEREFORE, THE POD8 WAS REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING NINE POD PACKING COILS (POD PCS) AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11865547 ↗
• MalfunctionApr 25, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING POD COILS AND A NON-PENUMBRA MICROCATEHTER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE POD COIL THROUGH THE DISTAL TIP OF THE MICROCATHETER. THE PHYSICIAN DECIDED TO REMOVE THE COIL AND, UPON WITHDRAWAL, NOTICED THAT THE POD COIL WAS NOT CONNECTED TO THE PUSHER WIRE AND WAS DETACHED INSIDE THE MICROCATHETER. IT WAS REPORTED THAT THE POD COIL WAS COMPLETELY CONTAINED INSIDE THE MICROCATHETER; THEREFORE, THE MICROCATHETER WAS REMOVED FROM THE PATIENT. SUBSEQUENTLY, THE POD COIL WAS REMOVED FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER POD COIL, A POD PACKING COIL (POD PC), 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 11722048 ↗
• MalfunctionMar 18, 2021Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GONADAL VEIN USING POD COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A GUIDE CATHETER. DURING THE PROCEDURE, WHILE ADVANCING A POD COIL INTO THE TARGET VESSEL, THE GUIDE CATHETER KICKED BACK OUT OF THE VESSEL AND THE PHYSICIAN WAS UNABLE TO ADVANCE THE REMAINDER OF THE POD COIL INTO THE TARGET LOCATION. THE PHYSICIAN RE-SHEATH THE POD COIL AND REPOSITIONED THE GUIDE CATHETER TO REGAIN ACCESS INTO THE VESSEL. SUBSEQUENTLY, WHILE ATTEMPTING TO ADVANCE THE SAME POD COIL INTO THE TARGET LOCATION, THE HOSPITAL TECHNOLOGIST EXPERIENCED RESISTANCE AND THE POD COIL WOULD ONLY ADVANCE APPROXIMATELY ONE TO TWO CENTIMETERS WITHIN THE INTRODUCER SHEATH. THE HOSPITAL TECHNOLOGIST ATTEMPTED TO PUSH THE POD COIL AGAINST RESISTANCE AND, CONSEQUENTLY, KINKED THE PUSHER ASSEMBLY OF THE POD COIL. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL AND GUIDE CATHETER WITH THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11520319 ↗
• MalfunctionMar 15, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING POD COILS, A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA GUIDING SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN FLUSHED THE MICROCATHETER AND THEN ATTEMPTED TO ADVANCE A POD COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER. HOWEVER, THE POD COIL WOULD NOT ADVANCE AT ALL. SUBSEQUENTLY, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE POD COIL. THEREFORE, THE POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE RUBY COILS, THE SAME MICROCATHETER, AND THE SAME GUIDING SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11490222 ↗
• MalfunctionMar 4, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT RENAL ARTERY USING POD COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE POD COIL APPROXIMATELY HALFWAY THROUGH THE MICROCATHETER. THEREFORE, THE POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL 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 11417937 ↗
• MalfunctionDec 21, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A POD5 COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER AND DECIDED TO RETRACT THE POD5 COIL. UPON RETRACTION, THE POD5 COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD5 COIL WAS REMOVED. AFTERWARDS, THE PHYSICIAN ADVANCED A NEW POD6 COIL THROUGH A NEW MICROCATHETER AND WHILE ADVANCING THE POD6 COIL INTO THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY THE PUSHER ASSEMBLY OF THE POD6 COIL KINKED AND THE PHYSICIAN THEN DECIDED TO RETRACT THE POD6 COIL. UPON RETRACTION, THE PHYSICIAN NOTICED THAT THE POD6 COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD6 COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME SECOND 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 11052664 ↗
• MalfunctionOct 27, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO LOAD THE POD COIL INTO THE MICROCATHETER, THE PUSHER ASSEMBLY OF THE POD COIL BECAME KINKED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW POD 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 10744605 ↗
• MalfunctionOct 17, 2020Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A POD COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL MIDWAY THROUGH THE MICROCATHETER, THE POD COIL BECAME STUCK; THEREFORE, THE POD COIL WAS REMOVED. AFTER THE REMOVAL, IT WAS NOTED THAT THE POD COIL WAS DAMAGED AND COULD NOT BE REUSED. THE PROCEDURE WAS COMPLETED USING A SMALLER COIL 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 10694500 ↗
• MalfunctionSep 17, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING A POD COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL HALFWAY THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND HAD DIFFICULTY ADVANCING THE POD COIL FURTHER; THEREFORE, THE POD COIL AND LANTERN WERE REMOVED. THE PROCEDURE WAS COMPLETED USING THREE OTHER COILS AND A NON-PENUMBRA 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 10547484 ↗
• MalfunctionSep 1, 2020Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PANCREATICODUODENAL ARTERY USING POD COILS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A POD6 INTO THE TARGET VESSEL USING THE MICROCATHETER, THE DISTAL LOOPS OF THE POD6 WOULD FORM; HOWEVER, THE COIL WOULD NOT ANCHOR. THEREFORE, THE POD6 WAS RE-SHEATHED AND SAVED FOR LATER USE. THE PHYSICIAN THEN ADVANCED A POD5 INTO THE VESSEL; BUT THE SAME ISSUE OCCURRED AND, THEREFORE, THE POD5 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME POD6, POD PACKING COIL (POD PC), AND RUBY COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10480512 ↗
• MalfunctionAug 28, 2020Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS, A RUBY COIL, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD COIL INTO THE TARGET LOCATION USING THE LANTERN; HOWEVER, THE POD6 COIL WOULD NOT TAKE ITS INTENDED SHAPE OR WOULD MIGRATE DISTALLY. THEREFORE, THE POD6 COIL WAS REMOVED. THE PHYSICIAN THEN ADVANCED A POD5 COIL INTO THE TARGET LOCATION USING THE LANTERN; HOWEVER, THE POD COIL WOULD NOT TAKE ITS INTENDED SHAPE OR WOULD MIGRATE DISTALLY. THEREFORE, THE POD5 COIL WAS REMOVED. THEN, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE TARGET LOCATION USING THE LANTERN; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A POD6 COIL AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10466869 ↗
• MalfunctionAug 6, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS, RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE), AND NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD COIL TO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH THE POD COIL USING THE HANDLE. HOWEVER, THE HANDLE FAILED TO ATTACH THE POD COIL. SUBSEQUENTLY, THE POD COIL WAS REMOVED, AND THE PHYSICIAN IMPLANTED TWO PENUMBRA COILS IN THE VESSEL. THE PHYSICIAN THEN ADVANCED THE NEXT POD COIL AND A RUBY COIL SEPARATELY TO THE VESSEL, BUT THE SAME ISSUE OCCURRED; THE HANDLE FAILED TO DETACH THE POD COIL AND RUBY COIL. THEREFORE, THE POD COIL AND RUBY COIL WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PENUMBRA COIL AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10376096 ↗