POD RBYPOD5Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI M424RBYPOD50), received between Oct 16, 2015 and May 4, 2021 — classified as 3 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (16 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), POD COILS, AND A NON-PENUMBRA SHEATH. IT WAS NOTED THAT VASCULAR ACCESS WAS SLIGHTLY DIFFICULT. DURING THE PROCEDURE, THE PHYSICIAN INTRODUCED THE LANTERN INTO THE SHEATH TO THE TARGET LOCATION. WHILE ADVANCING A FEW CENTIMETERS OF A POD COIL THROUGH THE DISTAL TIP OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE POD COIL WOULD NOT ADVANCE FURTHER. THEREFORE, THE POD COIL WAS REMOVED. WHILE ATTEMPTING TO ADVANCE A NEW POD COIL, RESISTANCE WAS EXPERIENCED; HOWEVER, THE PHYSICIAN WAS ABLE TO PLACE THE POD COIL INTO THE TARGET VESSEL SUCCESSFULLY. THE PHYSICIAN THEN DECIDED TO REMOVE THE LANTERN DUE TO THE RESISTANCE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PENUMBRA COILS AND A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773597 ↗
• MalfunctionJan 5, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A FISTULA USING POD COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE POD COIL WAS UNABLE TO PASS THROUGH THE FRICTION LOCK WITHIN THE INTRODUCER SHEATH. THEREFORE, THE POD COIL 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 11120736 ↗
• MalfunctionFeb 18, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD5 AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE POD5 THROUGH THE MICROCATHETER, THE POD5 UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED POD5. THE PROCEDURE WAS COMPLETED USING A NEW POD5 AND NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9721766 ↗
• MalfunctionSep 9, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR GLUTEAL ARTERY (SGA) USING A POD5 AND LANTERN DELIVERY MICROCATHETERS (LANTERNS). DURING PREPARATION FOR THE PROCEDURE, A LANTERN (F85569) WAS FOUND TO BE KINKED APPROXIMATELY 30 CM FROM THE PROXIMAL END UPON REMOVAL FROM PACKAGING. THE DAMAGE TO THE LANTERN WAS FOUND PRIOR TO USE, AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED ONE POD5 AND TWO RUBY COILS IN THE TARGET VESSEL USING ANOTHER LANTERN. WHILE ADVANCING A POD5 JUST BEYOND THE HUB OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE LANTERN CONTAINING THE POD5 WAS REMOVED. IT WAS REPORTED THAT THERE WAS NO NOTED DAMAGE TO THE LANTERN AFTER REMOVAL. HOWEVER, FLUSHING THE LANTERN DID NOT RESOLVE THE INCIDENT AND THEREFORE, IT WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER POD5, THREE RUBY COILS, AND A THIRD LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8975139 ↗
• MalfunctionJul 3, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD5 AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS EXTREMELY TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE POD5 THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE POD5 BECAME STUCK AND WOULD NOT EXIT THE TIP OF THE LANTERN. THEREFORE, THE PHYSICIAN DETACHED THE POD5 USING A POD COIL DETACHMENT HANDLE (HANDLE) WITHIN THE LANTERN AND ATTEMPTED TO FLUSH IT; HOWEVER, THE POD5 DID NOT MOVE. THEREFORE, THE LANTERN AND POD5 WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND ANOTHER MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8761180 ↗
• MalfunctionJun 14, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL TECHNICIAN FOUND THAT A POD5 WAS KINKED WITHIN ITS PACKAGING. THE DAMAGE TO THE POD5 WAS FOUND PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW POD5.

  Patient problems: No Patient Involvement

  MAUDE report 8699715 ↗
• MalfunctionMay 28, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) AND THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND POD5S. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE FIRST RUBY COIL WAS ADVANCED INTO THE IMA USING A LANTERN DELIVERY MICROCATHETER (LANTERN), BUT WOULD NOT TAKE SHAPE IN THE VESSEL. THE RUBY COIL WAS THEREFORE REMOVED AND NOT USED IN THE PROCEDURE. THE PHYSICIAN ATTEMPTED TO ADVANCE A POD5; HOWEVER, THE POD5 WAS UNABLE TO ADVANCE OUT OF THE ROTATING HEMOSTASIS VALVE (RHV)AND INTO THE LANTERN AND WAS THEREFORE REMOVED. ANOTHER POD5 WAS THEN IMPLANTED SUCCESSFULLY IN THE IMA USING THE SAME LANTERN. THE PHYSICIAN ADVANCED ANOTHER RUBY COIL INTO THE IIA AND MADE SEVERAL ATTEMPTS TO REPOSITION IT WITHIN THE VESSEL. WHILE RETRACTING THE RUBY COIL INTO THE LANTERN DURING AN ATTEMPT TO REPOSITION, THE RUBY COIL UNINTENTIONALLY DETACHED AND BROKE INTO TWO PIECES. IT WAS NOTED THAT ONE PIECE OF THE RUBY COIL BROKE OFF IN THE PATIENT'S VESSEL AND ANOTHER PIECE BROKE OFF INSIDE THE LANTERN. THE LANTERN AND PIECE OF THE RUBY COIL WERE REMOVED TOGETHER FROM THE PATIENT AND A SNARE WAS USED TO RETRIEVE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8646293 ↗
• MalfunctionMay 2, 2019Device Damaged Prior to Use; Device Fell; Device Damaged Prior to Use; Device Fell

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MESENTERIC ARTERY AND THE AORTA USING POD5S AND RUBY COILS. DURING THE PROCEDURE, THE FELLOW ACCIDENTALLY DROPPED A POD5 ON THE FLOOR WHILE REMOVING IT FROM THE PACKAGING HOOP. THE POD5 WAS DROPPED PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS THEN CONTINUED USING A NEW POD5. THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE FELLOW THEN ACCIDENTALLY KINKED A RUBY COIL (F83494) WHILE REMOVING IT FROM THE PACKAGING HOOP. THE PHYSICIAN STILL ATTEMPTED TO ADVANCE THE RUBY COIL THROUGH THE LANTERN, HOWEVER, WAS UNABLE TO. THEREFORE, THE RUBY COIL WAS REMOVED, AND A NEW RUBY COIL WAS SUCCESSFULLY PLACED. THROUGHOUT THE REMAINDER OF THE PROCEDURE, THREE MORE RUBY COILS WERE INADVERTENTLY KINKED UPON REMOVAL FROM THEIR PACKAGING HOOPS AND, THEREFORE, NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING OTHER RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8575022 ↗
• MalfunctionMay 1, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE FEMORAL VEIN USING POD5. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING A POD5 AND, THEREFORE, THE PHYSICIAN ATTEMPTED TO REMOVE THE POD5. WHILE RETRACTING, THE POD5 UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER WITH THE COIL INSIDE. THE PROCEDURE WAS THEN COMPLETED USING A NEW MICROCATHETER AND A NEW RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8570081 ↗
• MalfunctionDec 26, 2018Failure to Fold; Premature Separation; Failure to Fold; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE EPIGLOTTIS ARTERY USING POD5. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO FORM THE POD5 IN THE TARGET LOCATION USING A NON-PENUMBRA MICROCATHETER; THEREFORE, IT WAS REMOVED AND SAVED FOR LATER USE. THE PHYSICIAN THEN PLACED THREE PODS AND PENUMBRA COIL 400S (PC400S) IN THE TARGET VESSEL. UPON INSPECTING THE SHAPE OF THE INITIAL POD5 OUTSIDE OF THE PATIENT¿S BODY, THE POD5 DETACHED. THEREFORE, THE POD5 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW POD5, PENUMBRA SMART COILS, AND ADDITIONAL COILS WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8197737 ↗
• MalfunctionOct 1, 2018Defective Device; Physical Resistance/Sticking; Defective Device; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD5S. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A POD5 WITHIN A LANTERN DELIVERY MICROCATHETER (LANTERN) AND, THEREFORE, THE POD5 WAS REMOVED. IT WAS NOTED THAT THERE WAS DAMAGE TO THE POD5. THE PROCEDURE WAS COMPLETED USING RUBY COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Urinary Retention

  MAUDE report 7924208 ↗
• MalfunctionSep 7, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD5S. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A POD5 THROUGH THE MIDDLE OF A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN, THEREFORE, REMOVED THE POD5 AND COMPLETED THE PROCEDURE USING NEW 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 7855833 ↗
• MalfunctionAug 3, 2018Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY USING POD5S. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A POD5 FROM THE CONTRALATERAL SIDE TO THE TREATMENT SITE USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AT THE MIDDLE OF THE LANTERN AND THEREFORE, THE POD5 WAS REMOVED. THE PHYSICIAN THEN TRIED TO RE-INSERT IT AGAIN; HOWEVER, RESISTANCE WAS ENCOUNTERED AT THE SAME POSITION. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER POD5, FOUR POD COILS, TWO PENUMBRA COILS 400, OTHER 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 7749223 ↗
• MalfunctionJul 13, 2018Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS (AV) FISTULA USING A POD5. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD5 INTO THE PATIENT¿S BODY USING A NON-PENUMBRA MICROCATHETER; HOWEVER, THE PHYSICIAN DID NOT LIKE THE WAY THE POD5 WAS PACKING AND REMOVED IT FROM THE PATIENT. THE POD5 INTRODUCER SHEATH WAS FLUSHED AND THE EMBOLIZATION COIL WAS DIPPED IN HEPARINIZED SALINE TO REMOVE ALL BLOOD. THE MICROCATHETER WAS ALSO FLUSHED. HOWEVER, WHILE RE-ADVANCING THE POD5 INTO THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED AND THE HOSPITAL TECHNOLOGIST INADVERTENTLY KINKED THE POD5 PUSHER ASSEMBLY BEFORE LETTING UP TENSION ON THE PUSHER ASSEMBLY; THEREFORE, THE POD5 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER, ADDITIONAL RUBY COILS AND POD PACKING COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7686328 ↗
• MalfunctionMay 7, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD5S. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A POD5 OUT OF ITS INTRODUCER SHEATH AND INTO A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE POD5 WAS THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING THE SAME PX SLIM AND A POD PACKING COIL (PODJ). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7491783 ↗
• MalfunctionMay 3, 2018Kinked; Inadequacy of Device Shape and/or Size; Kinked; Inadequacy of Device Shape and/or Size

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (AVM) USING A POD5, A POD PACKING COIL (PODJ), RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY A POD5 INTO THE TARGET VESSEL USING THE LANTERN, THE PHYSICIAN DETERMINED THAT THE POD5 WAS OVERSIZED AND DECIDED TO RETRACT IT; HOWEVER, DURING THE RETRACTION, THE POD5 BECAME KINKED. THE PHYSICIAN THEN OPENED A PODJ AND ATTEMPTED TO ADVANCE IT THROUGH THE LANTERN; HOWEVER, THE PODJ KICKED THE LANTERN OUT OF THE ANEURYSM AND THEREFORE, THE PODJ WAS REMOVED. THE PHYSICIAN THEN SMOOTHLY ADVANCED A RUBY COIL WITHIN THE LANTERN UNTIL THE LAST ONE CENTIMETER FROM THE DISTAL TIP OF THE LANTERN AND THE PHYSICIAN THOUGHT THAT THERE MAY BE A KINK IN THE LANTERN; THEREFORE, THE LANTERN AND RUBY COIL WERE REMOVED. UPON REMOVAL, THE LANTERN WAS CONFIRMED TO BE KINKED. THE PROCEDURE WAS COMPLETED USING OTHER COILS, THE SAME DIAGNOSTIC CATHETER, A NEW LANTERN AND ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7485436 ↗
• MalfunctionMar 26, 2018Failure to Fold; Device Operates Differently Than Expected; Failure to Fold; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD4, A POD5, A POD6 AND POD8'S. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A POD4 IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE POD4 WOULD NOT TAKE ITS INTENDED SHAPE AND THE COIL WAS REMOVED. A POD5, POD6 AND TWO POD8'S WERE OPENED; HOWEVER, THE PHYSICIAN EXPERIENCED THE SAME ISSUE. THEREFORE, THE PHYSICIAN REMOVED THE PODS AND SUCCESSFULLY COMPLETED THE PROCEDURE USING RUBY COILS 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 7371140 ↗
• MalfunctionMar 1, 2018Inadequacy of Device Shape and/or Size; Difficult to Advance; Inadequacy of Device Shape and/or Size; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A LARGE VARICOCELE USING RUBY COILS AND A POD5. DURING THE PROCEDURE, PRIOR TO USE, A RUBY COIL PUSHER ASSEMBLY BECAME KINKED WHILE BEING REMOVED FROM THE DISPENSER HOOP; THEREFORE IT WAS SET ASIDE AND THE PROCEDURE CONTINUED WITH OTHER COILS. THE PHYSICIAN THEN HAD DIFFICULTY ADVANCING A POD5 INTO THE EXISTING COIL MASS IN THE VARICOCELE DUE TO THE FACT THAT THE POD5 WAS THE WRONG SIZE; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING OTHER RUBY COILS AND THE SAME LANTERN DELIVERY MICROCATHETER (LANTERN). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7307935 ↗
• MalfunctionFeb 27, 2018Bent; Device Damaged Prior to Use; Out-Of-Box Failure; Bent; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL TECHNICIAN ACCIDENTALLY BENT THE PUSHER WIRE OF A POD5 WHILE REMOVING IT FROM ITS PACKAGING HOOP. THE DAMAGE TO THE POD5 OCCURRED PRIOR TO USE, AND THEREFORE IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW POD5.

  Patient problems: No Patient Involvement

  MAUDE report 7299572 ↗
• MalfunctionFeb 23, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY (IIA) USING POD5'S. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS SLIGHTLY TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED A POD COIL IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE A POD5 THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AROUND THE HUB OF THE LANTERN. THE PHYSICIAN THEN EXPERIENCED RESISTANCE AGAIN AFTER ADVANCING THE POD5 APPROXIMATELY 10 CENTIMETERS INTO THE LANTERN; THEREFORE, THE POD5 WAS REMOVED. THE POD5 WAS THEN SOAKED IN SALINE AND THE LANTERN FLUSHED THROUGH WITH SALINE. WHILE ATTEMPTING TO RE-ADVANCE THE POD5 THROUGH THE LANTERN, RESISTANCE WAS ENCOUNTERED AGAIN AT THE SAME POSITION; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN, A NEW POD5 AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7293763 ↗
• MalfunctionFeb 13, 2018Bent; Kinked; Physical Resistance; Device Handling Problem; Bent; Kinked; Physical Resistance; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS, AND POD5S. DURING THE PROCEDURE, THE HOSPITAL TECHNICIAN FELT RESISTANCE WHILE ADVANCING A RUBY COIL AND THEN A POD5 THROUGH THE LANTERN. THE HOSPITAL TECHNICIAN CONTINUED TO TRY TO ADVANCE THE COILS, AND CONSEQUENTLY THE PUSHER WIRES OF A RUBY COIL AND A POD5 BECAME KINKED/BENT. THE POD5 AND RUBY COIL WERE THEREFORE REMOVED, AND THE PHYSICIAN ALSO REMOVED THE LANTERN FROM THE NON-PENUMBRA SHEATH. UPON REMOVAL, THE LANTERN WAS FOUND TO BE KINKED, AND THE PROCEDURE WAS THEREFORE COMPLETED USING A NEW LANTERN, THE SAME SHEATH, AND ADDITIONAL RUBY COILS. IT WAS REPORTED THAT THE LANTERN MAY HAVE BECOME KINKED AS THE PHYSICIAN WAS REPOSITIONING IT WITHOUT USING A GUIDEWIRE, PRIOR TO ATTEMPTING TO PLACE THE POD5 AND RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7268478 ↗
• MalfunctionJan 19, 2018Failure to Fold; Device Operates Differently Than Expected; Failure to Fold; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD4S AND POD5S. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED AND ATTEMPTED TO PLACE BOTH A POD4 AND A POD5 USING A LANTERN DELIVERY MICROCATHETER (LANTERN), HOWEVER BOTH THE POD4 AND POD5 WERE UNABLE TO TAKE THEIR INTENDED SHAPE IN THE VESSEL, DUE TO THE HIGH FLOW IN THE VESSEL. THE POD4 AND POD5 WERE THEREFORE REMOVED, AND THE PROCEDURE WAS THEN COMPLETED USING MICROVASCULAR PLUGS AND RUBY COILS WITH THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7208069 ↗
• MalfunctionDec 29, 2017Kinked; Device Handling Problem; Kinked; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD PACKING COILS (PODJS), POD5S, AND RUBY COILS. DURING THE PROCEDURE, THE HOSPITAL STAFF ACCIDENTLY KINKED THE PUSHER WIRES OF A PODJ AND A POD5 WHILE ATTEMPTING TO ADVANCE THE COILS INTO A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PODJ AND POD5 WERE THEREFORE REMOVED. THE PHYSICIAN THEN ATTEMPTED TO PLACE A RUBY COIL USING THE LANTERN, HOWEVER DID NOT LIKE HOW THE COIL WAS FORMING WITHIN THE PATIENT. THE PHYSICIAN THEREFORE ATTEMPTED TO RETRACT THE RUBY COIL, HOWEVER ACCIDENTALLY RETRACTED THE LANTERN AND SHEATH AS WELL. THE PHYSICIAN THEREFORE RE-ADVANCED THE LANTERN AND SHEATH INTO THE TARGET LOCATION, AND AS THE PHYSICIAN RE-ATTEMPTED TO ADVANCE THE SAME RUBY COIL, IT UNINTENTIONALLY DETACHED. THE PHYSICIAN THEREFORE REMOVED THE LANTERN WITH THE RUBY COIL INSIDE, AND ONCE IT WAS OUTSIDE OF THE PATIENT, IT WAS FOUND THAT THE RUBY COIL HAD BROKEN IN TO TWO PIECES. BOTH OF THE PIECES WERE OUTSIDE OF THE PATIENT, AND THEREFORE THE PROCEDURE CONTINUED AND WAS COMPLETED USING ADDITIONAL PODJS AND RUBY COILS. DURING THE PROCEDURE, THREE DIFFERENT LANTERNS WERE USED BECAUSE THE PHYSICIAN NEEDED D

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7155433 ↗
• MalfunctionNov 2, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD4 AND A POD5. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A POD4 AND A POD5 THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE POD4 AND POD5 WOULD NOT ADVANCE OUT OF THE DISTAL END OF THE MICROCATHETER; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING 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 6996718 ↗
• MalfunctionAug 2, 2017Detachment Of Device Component; Device Operates Differently Than Expected; Detachment Of Device Component; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD5S. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD5 THROUGH THE LANTERN DELIVERY MICROCATHETER (LANTERN) AND INTO THE VESSEL; HOWEVER THE POD5 WOULD NOT TAKE ITS SHAPE WITHIN THE VESSEL. THE POD5 WAS THEREFORE REMOVED, AND THEN IT UNINTENTIONALLY DETACHED OUTSIDE OF THE PATIENT¿S BODY AS IT WAS RETRACTED INTO ITS INTRODUCER SHEATH. THE PROCEDURE WAS THEREFORE COMPLETED USING FOUR RUBY COILS 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 6761278 ↗