PX SLIM Delivery Microcatheter PXSLIMSTR-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00814548016436), received between Aug 28, 2015 and Aug 2, 2019 — classified as 2 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Kinked” (10 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.

• MalfunctionAug 2, 2019Compatibility Problem; Compatibility Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), AND PENUMBRA SMART COILS (SMART COILS). IT SHOULD BE NOTED THAT THERE WAS A TORTUOUS TONSILLAR LOOP IN THE COMMON CAROTID ARTERY (CCA). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE NEURON MAX INTO THE PATIENT¿S ANATOMY BUT FELT THAT IT WOULD NOT PROVIDE ENOUGH SUPPORT TO GUIDE THE PX SLIM OVER THE TONSILLAR LOOP. THEREFORE, THE NEURON MAX WAS REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PHYSICIAN THEN DECIDED TO USE A BENCHMARK AS THE GUIDE. HOWEVER, WHILE ADVANCING THE BENCHMARK HALFWAY THROUGH THE TONSILLAR LOOP, IT WAS REPORTED THAT THE BENCHMARK FELT STIFF. THE PHYSICIAN DECIDED NOT TO ADVANCE THE BENCHMARK ANY FURTHER INTO THE PATIENT¿S ANATOMY AND IT WAS THEREFORE REMOVED FROM THE PROCEDURE. A NON-PENUMBRA SHEATH WAS THEN ADVANCED, FOLLOWED BY THE SAME PX SLIM; HOWEVER, THE PX SLIM WAS NOT COMPATIBLE WITH THE TECHNIQUE THE PHYSICIAN PREFERRED TO USE AND WAS THEREFORE REMOVED FROM THE PROCEDURE. THERE WAS NO OTHER ISSUE NOTED WIT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8858101 ↗
• MalfunctionJul 16, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A RUBY COIL AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE RUBY COIL THROUGH THE PX SLIM, THE RUBY COIL BECAME STUCK INSIDE OF THE PX SLIM; THEREFORE, PHYSICIAN ATTEMPTED TO RETRACT IT. WHILE RETRACTING THE RUBY COIL NO RESISTANCE WAS EXPERIENCED; HOWEVER, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE PX SLIM. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE PX SLIM CONTAINING THE DETACHED RUBY COIL; HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE PHYSICIAN WAS UNABLE TO REMOVE THE PX SLIM. THEREFORE, THE PHYSICIAN REMOVED THE GUIDE CATHETER, THE PX SLIM AND RUBY COIL TOGETHER. THE PROCEDURE WAS THEN COMPLETED USING ANOTHER MICROCATHETER AND OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8795681 ↗
• MalfunctionApr 4, 2018Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OPHTHALMIC ARTERY USING PENUMBRA COILS 400 (PC400¿S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE THE FIRST PC400 INTO THE ANEURYSM, THE PC400 MIGRATED DOWN INTO THE PARENT VESSEL; THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE PC400. WHILE ATTEMPTING TO RETRACT THE PC400, IT UNINTENTIONALLY DETACHED WITH APPROXIMATELY FOUR CENTIMETERS OF THE COIL OUTSIDE OF THE PX SLIM. THEREFORE, THE PHYSICIAN ATTACHED A SYRINGE TO THE BACK OF THE PX SLIM AND APPLIED SUCTION TO SUCCESSFULLY REMOVE THE PX SLIM AND DETACHED PC400 TOGETHER. UPON REMOVAL OF THE PX SLIM, IT WAS NOTICED THAT THE PX SLIM WAS BROKEN AT THE MID-SHAFT. THE PROCEDURE WAS COMPLETED USING THE SAME SHEATH, A NEW PX SLIM AND ADDITIONAL PC400¿S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7397472 ↗
• MalfunctionApr 4, 2018Physical Resistance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT FEMORAL ARTERY USING PENUMBRA COILS 400 (PC400¿S) AND A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM). AFTER REACHING THE TARGET VESSEL, THE PHYSICIAN USED THE HANDLE TO DETACH THE PC400. UPON REMOVAL OF THE PX SLIM, THE PHYSICIAN NOTICED THAT THE PC400 RETURNED WITH THE PX SLIM AND THAT THE PC400 WAS NOT DETACHED. THE PROCEDURE WAS ENDED AT THAT POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7396123 ↗
• MalfunctionDec 6, 2017Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF FOUND THAT A PX SLIM DELIVERY MICROCATHETER (PX SLIM) WAS KINKED UPON REMOVAL FROM ITS PACKAGING. THE DAMAGE TO THE PX SLIM WAS FOUND PRIOR TO USE, AND THEREFORE THE PX SLIM WAS NOT USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM.

  Patient problems: No Patient Involvement

  MAUDE report 7087672 ↗
• MalfunctionOct 9, 2017Break; Detachment Of Device Component; Detachment of Device or Device Component; Break; Detachment Of Device Component; Detachment of Device or Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED MULTIPLE RUBY COILS IN THE TARGET VESSEL USING THE PX SLIM. WHILE ATTEMPTING TO ADVANCE THE LAST RUBY COIL THROUGH THE PX SLIM, THE PHYSICIAN DETERMINED THAT THE RUBY COIL WAS TOO LONG AND DECIDED TO RETRACT IT; HOWEVER, UPON RETRACTION, THE PX SLIM KICKED BACK AND THE RUBY COIL UNINTENTIONALLY DETACHED IN THE PATIENT¿S BODY. THEREFORE, THE PHYSICIAN ATTEMPTED TO USE A SNARE DEVICE TO REMOVE THE DETACHED RUBY COIL; HOWEVER, THE RUBY COIL BROKE OFF AND THE PHYSICIAN WAS UNABLE TO RETRIEVE THE ENTIRE RUBY COIL. THE PROXIMAL PORTION OF THE RUBY COIL WAS RETRACTED BACK INTO THE PX SLIM, AND THE DISTAL PORTION OF THE RUBY COIL REMAINED IN THE TARGET VESSEL. UPON REMOVAL OF THE PX SLIM, A HOLE WAS OBSERVED NEAR ITS DISTAL TIP. THE PROCEDURE WAS ENDED AT THIS POINT AS NO ADDITIONAL COILS WERE NEEDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6930420 ↗
• MalfunctionAug 31, 2017Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE PX SLIM AND RUBY COIL WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND ANOTHER PX SLIM. IT ADDITION, THERE WAS NO NOTED DAMAGE TO THE PX SLIM AFTER REMOVAL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6835965 ↗
• MalfunctionAug 22, 2017Kinked; Physical Resistance; Kinked; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED PC400S USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN THEN FELT RESISTANCE ADVANCING A PC400 THROUGH ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER, AND WAS UNABLE TO ADVANCE THE PC400 THROUGH THE PX SLIM; THEREFORE, THE PC400 WAS REMOVED. IT WAS NOTICED THAT THE PX SLIM WAS KINKED NEAR THE STRAIN RELIEF ON THE PROXIMAL END OF THE CATHETER; THEREFORE, THE PX SLIM WAS REMOVED. 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 6810485 ↗
• MalfunctionMar 10, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAVERNOUS CAROTID FISTULA USING PENUMBRA COILS 400 (PC400¿S) AND PX SLIM DELIVERY MICROCATHETERS (PX SLIM). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE INITIAL PC400S THROUGH A PX SLIM WITHOUT A ROTATING HEMOSTASIS VALVE (RHV) AND CONTINUOUS FLUSH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE COILS WOULD NOT ADVANCE THROUGH THE PX SLIM. THEREFORE, THE PX SLIM AND PC400S WERE REMOVED. THE PHYSICIAN THEN OPENED A NEW PX SLIM AND ATTEMPTED TO ADVANCE NEW PC400S; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THE PC400S WOULD NOT ADVANCE THROUGH THE NEW PX SLIM. THEREFORE, THE PC400S WERE REMOVED. IT WAS REPORTED THAT AFTER CONNECTING THE PX SLIM WITH A RHV, A FLUSH LINE AND HOLDING THE HUB OF THE PX SLIM STRAIGHT, THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400S 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 6395025 ↗
• MalfunctionJan 18, 2017Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED ANTERIOR COMMUNICATING ARTERY (A-COM) ANEURYSM USING PENUMBRA COILS 400 (PC400¿S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN PLACED A PC400 IN THE A-COM USING A PX SLIM; HOWEVER, THE PHYSICIAN WAS NOT SATISFY WITH THE PC400 AND THEREFORE, IT WAS REPLACED WITH A SMALLER PC400. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE TWO ADDITIONAL PC400S THROUGH THE SAME PX SLIM; HOWEVER BOTH PC400S WOULD NOT ADVANCE THROUGH THE PX SLIM; THEREFORE THEY WERE REMOVED. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO ADVANCE A MICRO-WIRE THROUGH THE PX SLIM PRIOR TO ATTEMPTING TO USE ADVANCE ONE LAST PC400; HOWEVER, THE LAST PC400 WOULD ONLY ADVANCE FEW CENTIMETERS INSIDE THE PX SLIM AND BECAME STUCK. THEREFORE, THE PX SLIM WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER¿S MICROCATHETER AND COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6260667 ↗
• MalfunctionJan 17, 2017Physical Resistance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400'S (PC400'S) AND TWO PX SLIM DELIVERY MICROCATHETERS (PX SLIM'S). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED AN INITIAL PC400 INTO THE ANEURYSM USING A PX SLIM. WHILE ATTEMPTING TO ADVANCE A NEW PC400 THROUGH THE PX SLIM AND INTO THE ANEURYSM, THE PHYSICIAN ADVANCED THE COIL ABOUT TWENTY CENTIMETERS INTO THE ANEURYSM AND THEN ENCOUNTERED RESISTANCE. SUBSEQUENTLY, THE COIL BECAME STUCK AND WAS UNABLE TO ADVANCE FURTHER. NEXT, THE PHYSICIAN REMOVED THE PC400 AND REPLACED THE PX SLIM WITH A NEW PX SLIM. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE SAME PC400 THROUGH THE NEW PX SLIM; HOWEVER, THE PC400 ADVANCED A FEW CENTIMETERS INTO THE ANEURYSM AND THEN BECAME STUCK. THEREFORE, THE PC400 AND PX SLIM WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PHYSICIAN USED A ROTATING HEMOSTASIS VALVE (RHV) AND MAINTAINED A CONTINUOUS FLUSH DURING THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6258966 ↗
• MalfunctionOct 26, 2016Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE RADIOLOGY TECHNOLOGIST INADVERTENTLY KINKED A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AT THE HUB WHILE REMOVING IT FROM ITS DISPENSER HOOP. IT WAS REPORTED THAT THE PX SLIM WAS PACKAGED IN THE OLD STYLE PACKAGING SYSTEM. THE KINKING OF 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 6057147 ↗
• InjuryOct 18, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING PENUMBRA COIL 400S (PC400) AND PX SLIM DELIVERY MICROCATHETERS (PX SLIM). DURING THE PROCEDURE, THE PC400 UNINTENTIONALLY DETACHED AS IT WAS BEING RETRACTED INTO THE 45 DEGREE PX SLIM TO BE REPOSITIONED, AND MIGRATED TO THE MIDDLE CEREBRAL ARTERY. THE 45 DEGREE PX SLIM WAS REMOVED. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DETACHED PC400 USING ANOTHER MANUFACTURER'S STENT RETRIEVER THROUGH ANOTHER MANUFACTURER'S MICROCATHETER; HOWEVER, THE PC400 BROKE INTO TWO PIECES AND ONLY PART OF THE COIL WAS RETRIEVED. THE SECOND PART WAS REMOVED ON ANOTHER PASS WITH THE STENT RETRIEVER, OPENING THE BLOCKED VESSEL. SUBSEQUENTLY, THE PHYSICIAN USED A NEW PX SLIM STRAIGHT AND IMPLANTED TWO PC400 COILS. THE PHYSICIAN THEN NOTICED ON THE ANGIOGRAPHY IMAGE THAT THE ANEURYSM WAS BLEEDING, AND REPORTED THAT THE PX SLIM CAUSED THE RUPTURE BY TOUCHING THE ANEURYSM DOME. THE PHYSICIAN THEN IMPLANTED TWO ADDITIONAL PC400 COILS; THE BLEEDING STOPPED, AND THE PROCEDURE WAS THEN COMPLETED.

  Patient problems: Blood Loss; Rupture

  MAUDE report 6038526 ↗
• MalfunctionAug 9, 2016Kinked; Mechanical Problem; Physical Resistance; Kinked; Mechanical Problem; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING A PC400 COIL THROUGH A PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE PC400 COIL OUT OF THE PX SLIM. THE PC400 COIL WAS RE-SHEATHED AND RE-INTRODUCED INTO THE PX SLIM. HOWEVER, THE PHYSICIAN WAS STILL UNABLE TO ADVANCE THE PC400 COIL OUT OF THE PX SLIM AND THE PC400 COIL PUSHER ASSEMBLY BECAME SLIGHTLY BENT. THEREFORE, THE PC400 COIL AND PX SLIM WERE REMOVED. THE PHYSICIAN ALSO REPORTED THAT THERE MAY HAVE BEEN A KINK AT THE DISTAL END OF THE PX SLIM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW PX SLIM AND EIGHT NEW PC400 COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5858190 ↗
• MalfunctionJul 22, 2016Kinked; Physical Resistance; Kinked; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING A RUBY COIL THROUGH THE PX SLIM AND EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE COIL BECAME STUCK SO THE PHYSICIAN ATTEMPTED REMOVE IT. HOWEVER, WHILE THE COIL WAS BEING RETRACTED, IT UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THE PHYSICIAN THEN REMOVED THE DETACHED RUBY COIL AND ATTEMPTED TO ADVANCE A NEW RUBY COIL THROUGH THE SAME PX SLIM. HOWEVER, THE PHYSICIAN STILL MET RESISTANCE. THE RUBY COIL BECAME STUCK AND WAS UNABLE TO ADVANCE THROUGH THE PX SLIM. THEREFORE, THE PHYSICIAN ATTEMPTED TO REMOVE THE RUBY COIL. HOWEVER, WHILE THE COIL WAS BEING RETRACTED, IT UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THE PHYSICIAN REMOVED PX SLIM CONTAINING THE DETACHED RUBY COIL FROM THE PATIENT. UPON INSPECTION OF THE PX SLIM, A KINK WAS OBSERVED. THE TECHNOLOGIST WAS UNSURE WHEN THE PX SLIM BECAME KINKED. THEREAFTER, THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM AND NEW RUBY COILS WITHOUT ANY FURTHER ISSUES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5817504 ↗
• MalfunctionJun 23, 2016Kinked; Kinked

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400) WITH A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, AFTER DEPLOYING TWO LOOPS OF A PC400 IN THE TARGET VESSEL, THE PHYSICIAN NOTICED THE PC400 WAS UNABLE TO ADVANCE ANY FURTHER. WHILE ATTEMPTING TO RETRACT THE PC400 BACK INTO THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE PC400 AND PX SLIM WERE REMOVED FROM THE PATIENT. THE PX SLIM WAS REINSERTED IN THE PATIENT AND AFTER FLUSHING CONTROL CONTRAST, THE PHYSICIAN NOTICED THE PX SLIM WAS BROKEN BETWEEN THE HUB AND THE STRAIN RELIEF. THE PX SLIM WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING 10 ADDITIONAL PC400 COILS WITH ANOTHER MANUFACTURERMICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5746766 ↗
• MalfunctionApr 21, 2016Material Too Rigid or Stiff; Physical Resistance; Material Integrity Problem; Material Too Rigid or Stiff; Physical Resistance; Material Integrity Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CORONARY FISTULA USING RUBY COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN USED SEVERAL OTHER MANUFACTURERS'' GUIDEWIRES TO POSITION THE PX SLIM IN THE TARGET VESSEL. WHILE ATTEMPTING TO DELIVER A RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WAS UNABLE TO ADVANCE THROUGH THE PX SLIM. THE PHYSICIAN REMOVED THE RUBY COIL AND THEN TRIED TO ADVANCE ANOTHER MANUFACTURER'S COIL THROUGH THE PX SLIM BUT MET RESISTANCE AGAIN AND REMOVED THE OTHER MANUFACTURER'S COIL. THE PHYSICIAN THEN MADE A SECOND ATTEMPT TO ADVANCE THE PREVIOUS RUBY COIL THROUGH THE PX SLIM AND THIS TIME AROUND, THE RUBY COIL ADVANCED THROUGH THE PX SLIM BUT ENCOUNTERED A LOT OF RESISTANCE. AFTER ADVANCING 1-2 CENTIMETERS, THE RUBY COIL BECAME STUCK IN THE PX SLIM AND COULD NOT BE ADVANCED OR RETRACTED. THEREFORE, THE PHYSICIAN RETRACTED THE PX SLIM AND THEN REMOVED THE RUBY COIL FROM THE PX SLIM. THE PX SLIM WAS THEN REMOVED AND INSPECTED FOR KINKS. THE PHYSICIAN DID NOT OBSERVE ANY KINKS BUT NOTICED THAT THE LAST 3 CENTIMETERS OF THE PX SLIM DISTAL TIP WAS ROUGH. THE PROCEDURE WAS SUCCESSF

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5596171 ↗
• MalfunctionMar 16, 2016Unraveled Material; Unraveled Material

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 COILS (PC400 COILS) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING THE PX SLIM INTO THE GUIDE CATHETER, THE PHYSICIAN NOTICED THAT THE STRAIN RELIEF OF THE PX SLIM HAD UNRAVELED AND DECIDED TO REMOVE THE PX SLIM. THE PHYSICIAN THEN ATTEMPTED TO USE A NEW PX SLIM FOR THE PROCEDURE; HOWEVER, IT WAS NOT LONG ENOUGH TO REACH THE TARGET VESSEL AND WAS REMOVED. THE PHYSICIAN THEN DEPLOYED A PC400 COIL INTO THE ANEURYSM USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY); HOWEVER, THE PC400 COIL FAILED TO DETACH USING THE PENUMBRA COIL DETACHMENT HANDLE (HANDLE) AND WAS REMOVED. NEXT, THE PHYSICIAN DEPLOYED A NEW PC400 COIL INTO THE ANEURYSM USING THE VELOCITY BUT DID NOT LIKE THE WAY THE COIL WAS FILLING THE ANEURYSM SO HE DECIDED TO REMOVE THE COIL. WHILE THE PC400 COIL WAS BEING WITHDRAWN, IT UNINTENTIONALLY DETACHED WITHIN THE ROTATING HEMOSTASIS VALVE (RHV). THERE WAS NO REPORT OF FRICTION OR RESISTANCE. THE DETACHED PC400 COIL AND VELOCITY WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER MANUFACTURER'S COILS. THERE WAS NO REPO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5503994 ↗
• MalfunctionJan 4, 2016Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OVARIAN VEIN USING RUBY COILS AND PX SLIM DELIVERY MICROCATHETERS (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN PLACED A PX SLIM IN THE TARGET VESSEL THROUGH ANOTHER MANUFACTURER'S GUIDE CATHETER. HOWEVER, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL THROUGH THE PX SLIM AND THEY WERE BOTH REMOVED FROM THE PATIENT. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE TWO NEW PX SLIM'S THROUGH A GUIDE CATHETER AND ANOTHER MANUFACTURER'S CATHETER BUT BOTH PX SLIM DEVICES WOULD NOT ADVANCE COMPLETELY OUT OF THE CATHETERS AND WERE REMOVED. THE PHYSICIAN ENDED THE PROCEDURE AT THIS POINT. IT IS UNKNOWN IF THERE WAS ANY ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5342412 ↗
• InjuryDec 21, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE RIGHT POSTERIOR INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400 COILS (PC400 COILS) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED SIX PC400 COILS INTO THE ANEURYSM WITH NO IMMEDIATE COMPLICATIONS USING THE PX SLIM. THE FOLLOWING DAY, THE PATIENT EXPERIENCED A SEVERE RIGHT POSTERIOR LIMBIC STROKE. THE EVENT REMAINED UNRESOLVED AND NO ACTIONS WERE TAKEN. THE REPORTED RIGHT POSTERIOR LIMBIC STROKE WAS ADJUDICATED TO HAVE AN UNCERTAIN RELATIONSHIP TO THE PC400 COILS AND A POSSIBLE RELATIONSHIP TO THE PX SLIM, ANGIOGRAPHIC PROCEDURE AND THE ANEURYSM STATE.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 5317017 ↗
• MalfunctionNov 20, 2015Kinked

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, AFTER ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE PX SLIM, THE PHYSICIAN NOTICED THAT THE PX SLIM WAS KINKED. THE PHYSICIAN REMOVED THE PX SLIM AND SUCCESSFULLY COMPLETED THE PROCEDURE USING A NEW PX SLIM AND THE SAME RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5241257 ↗
• MalfunctionOct 2, 2015Break; Device Damaged Prior to Use

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). UPON REMOVAL FROM THE PACKAGING, THE PX SLIM WAS FOUND BROKEN AND WAS NOT USED. THE PROCEDURE CONTINUED USING A NEW PX SLIM.

  Patient problems: No Patient Involvement

  MAUDE report 5123936 ↗
• MalfunctionSep 23, 2015Kinked

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND RUBY COILS. DURING THE PROCEDURE THE PX SLIM BECAME KINKED NEAR THE HUB AND WAS UNABLE TO DELIVER OR PASS COILS THROUGH IT. THE PHYSICIAN USED A NEW PX SLIM; HOWEVER, IT WAS ALSO KINKED. THE PHYSICIAN OPENED A THIRD PX SLIM AND SUCCESSFULLY DELIVERED 21 RUBY COILS; HOWEVER, ONE RUBY COIL WAS KINKED. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5099231 ↗
• MalfunctionSep 23, 2015Kinked

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND RUBY COILS. DURING THE PROCEDURE THE PX SLIM BECAME KINKED NEAR THE HUB AND WAS UNABLE TO DELIVER OR PASS COILS THROUGH IT. THE PHYSICIAN USED A NEW PX SLIM; HOWEVER, IT WAS ALSO KINKED. THE PHYSICIAN OPENED A THIRD PX SLIM AND SUCCESSFULLY DELIVERED 21 RUBY COILS; HOWEVER, ONE RUBY COIL WAS KINKED. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5098213 ↗
• MalfunctionSep 18, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE ADVANCING THE RUBY COIL THROUGH THE PX SLIM IT BECAME UNRAVELED. THE PHYSICIAN REMOVED BOTH THE PX SLIM AND RUBY COIL FROM THE PATIENT AND THE PROCEDURE CONTINUED USING ANOTHER MANUFACTURER'S PRODUCTS. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5089024 ↗