POD RBYPOD3-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00814548019581), received between Jul 20, 2018 and Apr 28, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (6 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MICRO VESSEL USING A RUBY COIL LP, A POD COIL, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL LP THROUGH THE MICROCATHETER, THE RUBY COIL LP BECAME STUCK AT THE DISTAL END OF THE MICROCATHETER, AND THE COIL HAD UNINTENTIONALLY DETACHED. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL LP WAS REMOVED AND THE COIL WAS FLUSHED OUT FROM THE MICROCATHETER. THE PHYSICIAN REINSERTED THE MICROCATHETER BACK INTO THE VESSEL AND WAS ADVANCING A POD COIL THROUGH THE MICROCATHETER. HOWEVER, THE POD COIL WOULD NOT ADVANCE OUT FROM THE MICROCATHETER, AND THE PHYSICIAN NOTICED THE POD COIL HAD UNINTENTIONALLY DETACHED. THE MICROCATHETER WAS REMOVED CONTAINING THE DETACHED POD COIL AND THE COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL, 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 21920766 ↗
• MalfunctionDec 12, 2024Premature Separation; 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, AFTER ADVANCING THE FIRST POD COIL THROUGH THE LANTERN AND INTO THE TARGET LOCATION, THE PHYSICIAN NOTICED THE POD COIL HAD UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE PHYSICIAN USED THE DETACHED POD COIL PUSHER ASSEMBLY TO PUSH THE TAIL END OF THE POD COIL AND ADJUST THE COIL INTO A BETTER POSITION WITHIN VESSEL. THE PROCEDURE WAS COMPLETED USING A NEW POD 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 20913744 ↗
• MalfunctionOct 24, 2022Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT FEMORAL VEIN USING A POD PACKING COIL (POD PC), A POD COIL, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, AFTER ADVANCING APPROXIMATELY HALF OF THE POD PC IN THE LANTERN, THE POD PC BECAME STUCK. THEREFORE, THE LANTERN CONTAINING THE POD PC WAS REMOVED. THE POD PC WAS THEN REMOVED FROM THE LANTERN AND THE LANTERN WAS REINSERTED INTO THE PATIENT. AFTERWARDS, WHILE ADVANCING THE POD COIL THROUGH THE LANTERN, THE PHYSICIAN BROKE THE PUSHER ASSEMBLY OF THE POD COIL. IT WAS REPORTED THAT THE EMBOLIZATION COIL WAS STILL ATTACHED TO THE PUSHER ASSEMBLY. THEREFORE, THE LANTERN CONTAINING THE POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW 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 15664541 ↗
• MalfunctionSep 29, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A POD COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE LANTERN, THE POD COIL UNINTENTIONALLY DETACHED PARTIALLY IN THE LANTERN AND PARTIALLY IN THE VESSEL. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE AND REMOVED THE POD COIL OUT OF THE PATIENT'S BODY. THE PROCEDURE ENDED AT THIS POINT AND THE VESSEL WAS NOT EMBOLIZED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15506430 ↗
• MalfunctionOct 16, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS, POD PACKING COILS (POD PCS), POD COILS, RUBY COIL DETACHMENT HANDLES (HANDLES) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED FIVE RUBY COILS, TWO POD PCS, AND TWO POD COILS INTO THE TARGET VESSEL USING THE LANTERN AND ATTEMPTED TO DETACH THEM USING TWO DIFFERENT HANDLES; HOWEVER, THE RUBY COILS, POD PCS AND POD COILS FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE FIVE RUBY COILS, TWO POD PCS AND TWO POD COILS. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THIS PATIENT.

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

  MAUDE report 10690988 ↗
• MalfunctionOct 16, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS, POD PACKING COILS (POD PCS), POD COILS, RUBY COIL DETACHMENT HANDLES (HANDLES) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED FIVE RUBY COILS, TWO POD PCS, AND TWO POD COILS INTO THE TARGET VESSEL USING THE LANTERN AND ATTEMPTED TO DETACH THEM USING TWO DIFFERENT HANDLES; HOWEVER, THE RUBY COILS, POD PCS AND POD COILS FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE FIVE RUBY COILS, TWO POD PCS AND TWO POD COILS. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THIS PATIENT.

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

  MAUDE report 10690924 ↗
• MalfunctionJul 24, 2020Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING POD COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED SEVERAL RUBY COILS USING THE LANTERN. WHILE ATTEMPTING TO IMPLANT A POD COIL, IT WAS REPORTED THAT THE COIL WOULD NOT TAKE ITS INTENDED SHAPE IN THE TARGET VESSEL. THEREFORE, THE POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A SHORTER RUBY 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 10323611 ↗
• MalfunctionJan 16, 2020Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LATERAL THORACIC ARTERY USING A POD3, RUBY COILS, NON-PENUMBRA DIAGNOSTIC CATHETER AND, LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE POD3 INTO THE TARGET VESSEL USING A LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD3 PUSHER ASSEMBLY BECAME BENT; THEREFORE, IT WAS REMOVED. NEXT, WHILE ADVANCING A RUBY COIL, THE PHYSICIAN WAS NOT SATISFIED OF THE LOCATION WHERE THE COIL HAD LANDED; THEREFORE, IT WAS REMOVED. WHILE RETRACTING, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE DIAGNOSTIC CATHETER AND BECAME STUCK. THEREFORE, THE LANTERN AND DIAGNOSTIC CATHETER WERE REMOVED CONTAINING THE DETACHED RUBY COIL. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL USING THE SAME LANTERN AND DIAGNOSTIC CATHETER. HOWEVER, IT WAS REPORTED THAT THE PHYSICIAN WAS MORE AGGRESSIVE WITH THE RUBY COIL AND THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME BENT AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS, THE SAME LANTERN AND DIAGNOSTIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9596905 ↗
• MalfunctionNov 4, 2019Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING POD3S. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD3 INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN); HOWEVER, THE POD3 WOULD NOT TAKE ITS INTENDED SHAPE AFTER SEVERAL ATTEMPTS AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW POD3 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 9272429 ↗
• MalfunctionOct 31, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GONADAL VEIN USING POD3S. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A POD3 AND POD4 INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ADVANCING THE NEXT POD3 THROUGH THE LANTERN, THE POD3 BECAME STUCK INSIDE, MID-SHAFT. THE POD3 WAS THEN REMOVED AND THE LANTERN WAS FLUSHED. THE PHYSICIAN THEN MADE THREE ADDITIONAL ATTEMPTS TO ADVANCE THE POD3 THROUGH THE LANTERN, HOWEVER, THE POD3 BECAME STUCK IN THE SAME LOCATION DURING EACH ATTEMPT AND WAS UNABLE TO ADVANCE ANY FURTHER. THEREFORE, THE POD3 WAS REMOVED FROM THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN AND A RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9263911 ↗
• MalfunctionOct 30, 2019Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING POD3S. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE DURING INSERTION OF THE POD3 INTO THE ROTATING HEMOSTASIS VALVE (RHV). SUBSEQUENTLY, THE POD3 PUSHER WIRE KINKED AND BROKE. THEREFORE, THE POD3 WAS REMOVED FROM THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW POD3. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9257083 ↗
• MalfunctionOct 2, 2019Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GONADAL VEIN USING POD10S AND POD3S. DURING THE PROCEDURE, A HOSPITAL TECHNOLOGIST NOTICED THE POD10 WAS KINKED UPON REMOVAL FROM ITS PACKAGING HOOP. THE DAMAGE TO THE POD10 WAS FOUND PRIOR TO USE, AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN OPENED AND PLACED ANOTHER POD10. NEXT, WHILE ADVANCING AND POSITIONING A POD3 IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER, THE POD3 WOULD NOT TAKE ITS INTENDED SHAPE TO IN THE VESSEL; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER POD3 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 9146053 ↗
• MalfunctionAug 20, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ACCESSORY RENAL ARTERY USING POD3S. DURING ADVANCEMENT OF THE POD3 APPROXIMATELY 10 CM INTO THE LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE POD3 PUSHER WIRE BECAME KINKED. THE POD3 WAS THEREFORE REMOVED FROM THE PATIENT AND RE-SHEATHED. THE PROCEDURE WAS COMPLETED USING A NEW POD3 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 8913120 ↗
• MalfunctionJul 26, 2019Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING A POD3, RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE HOSPITAL TECHNICIAN OPENED THE PACKAGING AND THE LANTERN WAS INADVERTENTLY DROPPED ON THE FLOOR. THEREFORE, THE LANTERN WAS NOT USED IN THE PROCEDURE. NEXT, THE PHYSICIAN PLACED A NEW LANTERN IN THE TARGET VESSEL AND ATTEMPTED TO ADVANCE A POD3; HOWEVER, THE COIL WOULD NOT TAKE ITS INTENDED SHAPE. THEREFORE, THE POD3 WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED, AND THE COIL WOULD NOT TAKE ITS INTENDED SHAPE, THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING A NON-PENUMBRA EMBOLIC AGENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8832865 ↗
• MalfunctionApr 3, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING POD3S. DURING THE PROCEDURE, THE POD3 WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH AFTER MULTIPLE ATTEMPTS; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8478326 ↗
• MalfunctionJan 30, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC ARTERY USING POD3S. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE FIRST POD3 THROUGH A NON-PENUMBRA MICROCATHETER INTO THE TARGET VESSEL. IT WAS ALSO REPORTED THAT THE POD3 PARTIALLY ADVANCED INTO THE TARGET VESSEL BEFORE IT KICKED BACK INTO THE MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO RE-ADVANCE THE POD3 INTO THE TARGET VESSEL, BUT THE SAME ISSUE OCCURRED. THE POD3 WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. 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 8291516 ↗
• MalfunctionJan 11, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERY USING POD3 COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE FIRST POD3 INTO A LANTERN DELIVERY MICROCATHETER (LANTERN) AND COULD ONLY ADVANCE THE POD3 APPROXIMATELY 10CM INTO THE HUB. THE POD3 WAS THEN WITHDRAWN AND REMOVED. THE PHYSICIAN THEN FOUND THAT THE POD3 WAS ABLE TO ADVANCE THROUGH ITS INTRODUCER SHEATH WITHOUT ISSUE OUTSIDE OF THE PATIENT. UPON ATTEMPTING TO RE-ADVANCE THE POD3 INTO THE LANTERN AGAIN, THE SAME ISSUE OCCURRED. THE POD3 WAS THEREFORE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER POD3 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 8241888 ↗
• MalfunctionOct 29, 2018Material Twisted/Bent; Material Twisted/Bent

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A POD3 AND A POD PACKING COIL (PODJ). DURING THE PROCEDURE, THE PHYSICIAN ACCIDENTALLY BENT THE PUSHER ASSEMBLY OF A POD3 WHILE ATTEMPTING TO ADVANCE THE POD3 THROUGH A LANTERN MICROCATHETER. IT WAS ALSO REPORTED THAT THE PUSHER ASSEMBLY OF THE PODJ WAS BENT WHEN ATTEMPTING TO ADVANCE IT THROUGH THE LANTERN. BOTH THE POD3 AND THE PODJ WERE, THEREFORE, REMOVED AND WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND POD COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8017595 ↗
• MalfunctionOct 11, 2018Device Damaged Prior to Use; Material Twisted/Bent; Device Damaged Prior to Use; Material Twisted/Bent

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD3S. DURING THE PROCEDURE, THE PHYSICIAN INSERTED A LANTERN DELIVERY MICROCATHETER (LANTERN) INTO PATIENT¿S BODY AND WAS CHECKING THE LANTERN POSITIONING ON THE SCREEN. DURING THE SAME TIME, THE HOSPITAL TECHNOLOGIST PULLED A POD3 OUT OF ITS DISPENSER HOOP AND NOTICED THE PUSHER WIRE WAS BENT; THEREFORE, IT WAS NOT USED IN THE PROCEDURE. IT IS UNCLEAR IF THE POD3 PUSHER WIRE WAS BENT PRIOR TO RETRACTING IT OUT OF THE PACKAGING HOOP. THE PROCEDURE WAS COMPLETED USING A NEW POD3 WITH THE SAME LANTERN.

  Patient problems: No Patient Involvement

  MAUDE report 7958000 ↗
• MalfunctionAug 17, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A POD3 AND POD4. IT WAS NOTED THAT THIS WAS AN EXTREMELY HIGH FLOW ENVIRONMENT. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO GET THE POD4 AND POD3 TO ANCHOR. IT WAS REPORTED THAT THE PHYSICIAN MADE MULTIPLE ATTEMPTS BUT THE COILS KEPT RUNNING; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING TWO RUBY COILS, A POD PACKING COIL. THERE WAS NO REPORT OF ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7794033 ↗
• MalfunctionJul 20, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD3S. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A POD3 OUT OF THE TIP OF THE INTRODUCER SHEATH AND REPORTED THAT THE POD3 WAS STUCK. THE POD3 WAS, THEREFORE, REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW POD3, 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 7708097 ↗