PX SLIM Delivery Microcatheter PXSLIM045-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00814548016412), received between Oct 15, 2015 and Nov 2, 2023 — classified as 53 malfunctions.

The most frequently reported specific device problem is “Physical Resistance” (21 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 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE UTERINE ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN INTRODUCED THE PX SLIM INTO THE TARGET VESSEL AND WHILE ATTEMPTING TO TORQUE THE PX SLIM TO SELECT THE TARGET VESSEL, THE PHYSICIAN WAS UNABLE TO TORQUE THE PX SLIM. THEREFORE, THE PX SLIM WAS REMOVED. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE PX SLIM WAS FRACTURED AT THE PROXIMAL END. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA MICROCATHETER AND THE SAME CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18059269 ↗
• MalfunctionMar 21, 2023Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96) AND A ROTATING HEMOSTASIS VALVE (RHV). DURING THE PROCEDURE, THE PX SLIM BROKE IN THE RHV. THEREFORE, THE PX SLIM WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM AND THE SAME BMX96. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16585218 ↗
• MalfunctionAug 20, 2022Fracture; Leak/Splash; Material Deformation; Fracture; Leak/Splash; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THE PX SLIM WAS LEAKING UPON FLUSHING IT. SUBSEQUENTLY, THE PHYSICIAN NOTICED THAT THE MIDSHAFT OF THE PX SLIM WAS KINKED AND FRACTURED. IT WAS REPORTED THAT THE KINKED AND FRACTURED PORTION OF THE PX SLIM WAS OUTSIDE OF THE ROTATING HEMOSTASIS VALVE (RHV) AND NEURON MAX. THEREFORE, THE PX SLIM WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM WITH THE SAME NEURON MAX AND RHV. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15263005 ↗
• MalfunctionDec 3, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT FEMORAL ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM), PENUMBRA COIL 400 (PC400S), A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE), AND A 5F GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE 5F GUIDE CATHETER CLOSE TO THE FISTULA, THEN ADVANCED A PX SLIM THROUGH THE GUIDE CATHETER AND INTO THE TARGET LOCATION WITHOUT ANY ISSUE. SUBSEQUENTLY, THE PHYSICIAN ADVANCED A PC400 WITH RESISTANCE INTO THE TARGET LOCATION USING THE PX SLIM AND DETACHED THE PC400 USING THE HANDLE. NEXT, WHILE ADVANCING ANOTHER PC400 INTO THE TARGET LOCATION USING THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND, THEREFORE, DECIDED TO REMOVE THE PC400 AND SAVED FOR LATER USE. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE PX SLIM TO LOOSEN THE RESISTANCE; HOWEVER, WHEN THE PHYSICIAN INJECTED CONTRAST THROUGH THE PX SLIM, THE MIDSHAFT OF THE PX SLIM WAS NOTICED TO BE DAMAGED. THEREFORE, THE PX SLIM WAS REMOVED AND CONFIRMED TO BE KINKED. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM, THE SAME PC400, AND HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12926034 ↗
• MalfunctionOct 1, 2021Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE DEEP AND SHALLOW FEMORAL ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND A NON-PENUMBRA GUIDING SHEATH. DURING THE PROCEDURE, WHILE ADVANCING A PX SLIM FROM THE CONTRALATERAL SIDE AND THEN TURNING FROM ONE ILIAC BRANCH TO ANOTHER, IT WAS NOTICED THAT THE MID-SHAFT OF THE PX SLIM WAS BROKEN. THEREFORE, THE PX SLIM WAS REMOVED. ON THE BACK TABLE, WHILE EXAMINING THE BROKEN PX SLIM, THE PX SLIM BROKE AGAIN IN ANOTHER AREA. THEREFORE, THE PX SLIM WAS NO LONGER USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM 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 12565726 ↗
• MalfunctionSep 28, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM), PAC400 COIL, POD400 COIL AND PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, THE PHYSICIAN PLACED A FEW POD400 AND PAC400 INTO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE THE PX SLIM TO CROSS A LESION SECOND TIME, THE PROXIMAL END OF THE PX SLIM KINKED. CONSEQUENTLY, THE PAC400 AND POD400 WOULD NOT DEPLOY. THEREFORE, THE PX SLIM, PAC400 AND POD400 WERE REMOVED. IT WAS REPORTED THAT THE POD400 AND PAC400 DID NOT HAVE ANY ISSUE. NEXT, THE PHYSICIAN USED A NON-PENUMBRA MICROCATHETER AND PLACED SEVERAL SMART COILS IN THE TARGET LOCATION; HOWEVER, THE SUBSEQUENT SMART COIL WOULD NOT ADVANCE PAST THE FRICTION LOCK WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE NON-PENUMBRA COILS, TWO MORE SMART 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 12544741 ↗
• MalfunctionJul 30, 2021Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE EXTERNAL CAROTID ARTERY (ECA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE PX SLIM OVER THE GUIDEWIRE, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE TIP OF THE PX SLIM WAS MISSING. THEREFORE, THE PX SLIM WAS REMOVED BY PULLING IT OUT ALONG WITH THE GUIDEWIRE. THE TIP OF THE PX SLIM WAS LATER FOUND ON THE BACK TABLE BY THE PHYSICIAN AND IT HAD DETACHED DURING PREPARATION FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252207 ↗
• MalfunctionJul 16, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM), BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN USED A DUAL CATHETER APPROACH TO ACCESS THE FISTULA. WHILE TRYING TO ADVANCE THE 45 DEGREE PX SLIM SIDE BY SIDE AFTER PLACING THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN THE PX SLIM REACHED THE DISTAL TIP OF THE BENCHMARK MAX. SUBSEQUENTLY, PX SLIM BECAME KINKED APPROXIMATELY 3-5 CM FROM THE DISTAL END; THEREFORE, THE PX SLIM WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER STRAIGHT TIP PX SLIM, THE SAME MICROCATHETER AND THE SAME BENCHMARK MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12181045 ↗
• MalfunctionJan 7, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING A PENUMBRA COIL 400 (PC400) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING A PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PC400 BECAME STUCK. THE PHYSICIAN THEN DECIDED TO RETRACT THE PC400. HOWEVER, DURING RETRACTION, THE PHYSICIAN NOTICED THAT THE PC400 HAD UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE DETACHED PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND ANOTHER 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 11134460 ↗
• MalfunctionJan 7, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA COILS 400 (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING A PC400 OUT OF THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PC400 WOULD NOT ADVANCE FURTHER. THE PHYSICIAN THEN ATTEMPTED TO PULL THE PC400 IN THE PX SLIM AND EXPERIENCED RESISTANCE AGAIN. SUBSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THEREFORE, THE DETACHED PC400 AND PX SLIM 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11129422 ↗
• MalfunctionSep 18, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN OCCLUSION OF THE PELVIC VARICES USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND RUBY COILS. DURING THE PROCEDURE, THE DISTAL TIP OF THE PX SLIM BECAME DAMAGED WHILE IN USE IN THE PATIENT. SUBSEQUENTLY, A RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER AND WAS REMOVED FROM THE PROCEDURE. 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; No Consequences Or Impact To Patient

  MAUDE report 10557400 ↗
• MalfunctionAug 26, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PELVIC PAIN DISEASE IN THE OVARIAN VARICOSE VEIN USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL APPROXIMATELY FOUR TO FIVE CENTIMETERS AND THE PHYSICIAN WAS NOT SATISFIED; THEREFORE, THE RUBY COIL WAS RETRACTED BACK INTO THE PX SLIM. WHILE RE-ADVANCING THE RUBY COIL THROUGH THE PX SLIM, THE RUBY COIL BECAME STUCK WITHIN THE PX SLIM. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN ADVANCED ANOTHER RUBY COIL A FEW CENTIMETERS AND WAS UNSATISFIED WITH THE RUBY COIL DEPLOYMENT AND RETRACTED THE RUBY COIL BACK WITHIN THE PX SLIM. WHILE RE-ADVANCING THE RUBY COIL THROUGH THE PX SLIM, THE RUBY COIL BECAME STUCK WITHIN THE PX SLIM. THEREFORE, THE RUBY COIL AND PX SLIM WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND A MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10457262 ↗
• MalfunctionJul 2, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S), A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A PC400 IN THE TARGET VESSEL USING THE PX SLIM. WHILE ADVANCING THE NEXT PC400 THROUGH THE PX SLIM, THE PC400 BECAME STUCK; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE IT. WHILE RETRACTING THE PC400, THE PX SLIM BROKE APPROXIMATELY 30 CENTIMETERS FROM ITS HUB. IT WAS REPORTED THAT THE REST OF THE PX SLIM REMAINED WITHIN THE NON-PENUMBRA CATHETER. THEREFORE, THE PHYSICIAN PULLED THE CATHETER WITH THE BROKEN PX SLIM TOGETHER. THE PROCEDURE WAS COMPLETED USING A NEW PC400 AND A NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10222630 ↗
• MalfunctionJun 19, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL JUGULAR VEIN USING RUBY COILS, POD PACKING COILS (PODJ) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL (C16974) INTO THE TARGET VESSEL USING THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE DURING ADVANCING THE LAST THREE CENTIMETERS OF THE COIL AND, THEREFORE, THE PHYSICIAN DECIDED TO RE-SHEATH AND REDEPLOY THE RUBY COIL. HOWEVER, WHILE ADVANCING THE RUBY COIL THROUGH THE PX SLIM, THE COIL BECAME UNRAVELED. THEREFORE, THE PX SLIM WAS REMOVED CONTAINING THE UNRAVELED RUBY COIL AND SAFELY FLUSHED OUT THE COIL TO REMOVE IT. NEXT, THE PHYSICIAN ADVANCED A NEW RUBY COIL (F91740) THROUGH THE PX SLIM; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN WHILE ADVANCING THE LAST THREE CENTIMETERS OF THE RUBY COIL. THE PHYSICIAN DECIDED TO RE-SHEATH AND REDEPLOY THE RUBY COIL. HOWEVER, WHILE ADVANCING THE RUBY COIL, THE SAME ISSUE OCCURRED, AND THE RUBY COIL BECAME UNRAVELED. IT WAS ALSO REPORTED THAT THE RUBY COIL WAS CUT FROM THE END AS IT WAS STUCK INSIDE THE PX SLIM. THE PHYSICIAN THEN REMOVED THE PX SLIM CONTAINING THE REMAINING RUBY COIL AND SAFELY FLUSHED OUT THE COIL TO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10176888 ↗
• MalfunctionDec 2, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT POSTERIOR COMMUNICATING ARTERIES (PCOM) USING PENUMBRA COILS 400 (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE PC400S IN THE TARGET VESSEL. WHILE ADVANCING THE NEXT PC400 THROUGH A PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE PC400 UNINTENTIONALLY DETACHED WITH THE MAJOR PART HANGING IN THE VESSEL; THEREFORE, THE PHYSICIAN SUCCESSFULLY USED A STENT RETRIEVER DEVICE TO REMOVE THE DETACHED PC400, AND THE PX SLIM WAS REMOVED. THE PHYSICIAN THEN CONTINUED THE PROCEDURE AND PLACED A NON-PENUMBRA MICROCATHETER IN THE TARGET VESSEL AND ATTEMPTED TO PACK THE ANEURYSM WITH A PENUMBRA SMART COIL (SMART COIL). HOWEVER, THERE WAS NO SPACE LEFT IN THE ANEURYSM TO INSERT THE SMART COIL, AND THEREFORE, THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9396760 ↗
• MalfunctionNov 22, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND PX SLIM DELIVERY MICROCATHETERS (PX SLIMS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PX SLIM 045 INTO A NON-PENUMBRA DIAGNOSTIC CATHETER FOLLOWED BY AN 8X60 RUBY COIL. HOWEVER, THE 8X60 RUBY COIL WAS UNABLE TO ADVANCE THROUGH THE PX SLIM 045 AND RESISTANCE WAS EXPERIENCED DURING BOTH ADVANCEMENT AND RETRACTION. THE 8X60 RUBY COIL WAS SUBSEQUENTLY REMOVED. ANOTHER 8X60 RUBY COIL WAS THEN ADVANCED THROUGH THE PX SLIM 045 AND THE SAME ISSUE OCCURRED. THEREFORE, THIS 8X60 RUBY COIL WAS ALSO REMOVED. THE SAME ISSUE WAS THEN ENCOUNTERED WITH A THIRD 8X60 RUBY COIL, AND THIS COIL WAS ALSO REMOVED. FOLLOWING THESE EVENTS, THE PHYSICIAN DECIDED TO REMOVE THE PX SLIM 045 FROM THE PROCEDURE. THE PHYSICIAN CONTINUED THE PROCEDURE USING A PX SLIM STRAIGHT TIP AND REGAINED ACCESS TO THE TARGET VESSEL ON THE IPSILATERAL SIDE. ANOTHER 8X60 RUBY COIL WAS THEN ADVANCED INTO THE PX SLIM STRAIGHT TIP. WHILE ADVANCING THE 8X60 RUBY COIL OUT OF THE PX SLIM STRAIGHT TIP, THE PHYSICIAN ENCOUNTERED RESISTANCE AND REPORTED THAT THE 8X60 RUBY COIL BECAME PARTIALLY DETACHED. THE PX SLIM STRAI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9365076 ↗
• MalfunctionNov 11, 2019Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE PX SLIM INTO THE TARGET VESSEL. AFTER PLACING A PENUMBRA COIL 400 (PC400) IN THE TARGET VESSEL, THE PHYSICIAN REMOVED THE PX SLIM. WHILE RETRACTING, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PX SLIM DISTAL WAS FOUND TO BE FRACTURED UPON REMOVAL. NEXT, THE PHYSICIAN PLACED A NEW PX SLIM BUT, REPORTED THE SAME RESISTANCE ISSUED OCCURRED WHILE ADVANCING. AFTER PLACING ANOTHER PC400, THE PX SLIM WAS REMOVED; HOWEVER, WHILE RETRACTING THE SAME RESISTANCE OCCURRED AND THE PX SLIM DISTAL TIP WAS FOUND TO BE FRACTURED AGAIN UPON REMOVAL. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9306979 ↗
• MalfunctionJan 18, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400S (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING A PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PC400 BECAME STUCK. THEREFORE, THE PX SLIM AND PC400 WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM AND PC400. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8262021 ↗
• MalfunctionNov 2, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN NOTICED THAT THE TIP OF THE PX SLIM DELIVERY MICROCATHETER (PX SLIM) WAS STUCK TO THE MATERIAL OF THE COVER UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE PX SLIM OCCURRED PRIOR TO USE AND, THEREFORE, THE PX SLIM WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM.

  Patient problems: No Patient Involvement

  MAUDE report 8032927 ↗
• MalfunctionOct 17, 2018Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A COIL THROUGH THE PX SLIM AND, THEREFORE, THE COIL WAS REMOVED. THE PHYSICIAN THEN TESTED THE PX SLIM BY ADVANCING A GUIDEWIRE THROUGH IT AND CONFIRMED THAT IT WAS OBSTRUCTED. THE PX SLIM WAS THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER AND THE SAME COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7974620 ↗
• MalfunctionOct 1, 2018Fracture; Failure to Advance; Physical Resistance/Sticking; Fracture; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE INSERTING A PX SLIM INTO A NON-PENUMBRA DIAGNOSTIC CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PX SLIM WOULD NOT ADVANCE. UPON LOOKING UNDER FLUOROSCOPY, IT WAS NOTICED THAT THE PX SLIM WAS FRACTURED IN TWO PARTS INSIDE THE DIAGNOSTIC CATHETER. THEREFORE, THE DIAGNOSTIC CATHETER CONTAINING THE FRACTURED PX SLIM TIP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7924150 ↗
• MalfunctionFeb 9, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE UNIPOLAR ILIACS USING RUBY COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL THROUGH THE PX SLIM. THEREFORE, THE PX SLIM AND RUBY COIL WERE REMOVED. THE PHYSICIAN THEN PLACED A NEW PX SLIM AND ATTEMPTED TO RE-ADVANCE THE SAME RUBY COIL; HOWEVER, THE RUBY COIL WOULD NOT ADVANCE. SUBSEQUENTLY, THE RUBY COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7262317 ↗
• MalfunctionOct 11, 2017Physical Resistance; Difficult to Advance; Physical Resistance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL THORACIC ARTERY USING PENUMBRA COIL 400''S (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA ANGIOGRAPHIC CATHETER TOWARDS THE TARGET VESSEL AND THEN ATTEMPTED TO ADVANCE THE PX SLIM THROUGH THE CATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED AND AFTER ADVANCING THE PX SLIM APPROXIMATELY FIFTY CENTIMETERS INTO THE CATHETER, THE PHYSICIAN WAS UNABLE TO ADVANCE THE PX SLIM ANY FURTHER. THE PHYSICIAN THEN SWITCHED TO ANOTHER NON-PENUMBRA ANGIOGRAPHIC CATHETER AND SUCCESSFULLY ADVANCED THE SAME PX SLIM THROUGH THE CATHETER. NEXT, THE PHYSICIAN DEPLOYED AND DETACHED NINE PC400S INTO THE TARGET VESSEL USING THE PX SLIM. WHILE ATTEMPTING TO ADVANCE A NEW PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL. THEREFORE, THE PHYSICIAN REMOVED THE PC400 AND ATTEMPTED TO ADVANCE A NEW PC400 THROUGH THE PX SLIM; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THE NEW PC400 WOULD NOT ADVANCE AT ALL. THEREFORE, THE PC400 AND PX SLIM WERE BOTH REMOVED AND THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL PC400S AN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6943274 ↗
• MalfunctionApr 24, 2017Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE AFTER ADVANCING A PC400 25 CM INTO THE PX SLIM; CONSEQUENTLY, THE PC400 BECAME STUCK IN THE PX SLIM. THE PHYSICIAN THEREFORE, REMOVED THE PX SLIM WITH THE PC400 INSIDE, AND COMPLETED THE PROCEDURE USING A NEW PC400 AND A NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6517326 ↗
• MalfunctionMar 28, 2017Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (PAVM) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE PX SLIM HAD BECOME FRACTURED ABOUT 30 CM FROM THE TIP WHILE BEING ADVANCED ALONG A NON-PENUMBRA GUIDEWIRE. THEREFORE THE PX SLIM WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6439438 ↗