PX SLIM Delivery Microcatheter PXSLIM045-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00814548016405), received between Aug 14, 2015 and Mar 12, 2018 — classified as 2 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Physical Resistance” (11 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2018Mechanical Problem; Physical Resistance; Mechanical Problem; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT OPHTHALMIC CAROTID ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE A PENUMBRA COIL 400 (PC400) THROUGH THE PX SLIM, AND THEREFORE THE PX SLIM WAS REMOVED WITH THE PC400. THE PHYSICIAN THEN RE-ADVANCED THE SAME PX SLIM TO THE TARGET LOCATION, AND RE-ATTEMPTED TO ADVANCE THE SAME PC400 THROUGH THE PX SLIM. HOWEVER, THE PC400 WAS UNABLE TO ADVANCE AGAIN AND THEREFORE THE PX SLIM AND PC400 WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS THEN COMPLETED USING A NEW MICROCATHETER, THE SAME PC400, AND ADDITIONAL PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7332935 ↗
• MalfunctionFeb 26, 2018Tear, Rip or Hole in Device Packaging; Physical Resistance; Tear, Rip or Hole in Device Packaging; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BLEEDING ANEURYSM IN THE POSTERIOR COMMUNICATING ARTERY (PCOMM), USING PENUMBRA COIL 400S (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED MULTIPLE PC400S IN THE TARGET VESSEL USING THE PX SLIM. WHILE ADVANCING AND WITHDRAWING ANOTHER PC400 COIL THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PC400 UNINTENTIONALLY DETACHED WITHIN THE PX SLIM; HOWEVER, THE PHYSICIAN WAS ABLE TO PUSH AND SUCCESSFULLY PLACE THE DETACHED PC400 IN THE TARGET VESSEL. NEXT, THE PHYSICIAN ATTEMPTED TO PLACE ANOTHER PC400 IN THE TARGET VESSEL. HOWEVER, WHILE ADVANCING AND WITHDRAWING THE PC400, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN AND THE PC400 UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. WHEN ATTEMPTING TO MANEUVER THE DETACHED PC400, THE PUSHER ASSEMBLY OF THE PC400 PERFORATED THE PX SLIM. THEREFORE, THE PX SLIM WAS REMOVED WITH THE DETACHED PC400 AND THE PUSHER ASSEMBLY INSIDE, AS THE PHYSICIAN ASPIRATED THROUGH THE PX SLIM. THE PROCEDURE ENDED AT THIS POINT. IT WAS REPORTED THAT THE PHYSICIAN NEEDED TO APPLY FORCE WHILE PLACING THE PC4

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7298096 ↗
• MalfunctionFeb 16, 2018Physical Resistance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC USING A RUBY COIL AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED MULTIPLE RUBY COILS IN THE TARGET LOCATION USING THE PX SLIM. THE PHYSICIAN THEN EXPERIENCED RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH THE PX SLIM, AND THEREFORE, THE PX SLIM AND THE RUBY COIL WERE REMOVED. THE PROCEDURE WAS THEN COMPLETED USING A NEW PX SLIM 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 7277547 ↗
• MalfunctionDec 6, 2017Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INFERIOR EPIGASTRIC ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE PX SLIM THROUGH A NON-PENUMBRA GUIDE CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PX SLIM BECAME STUCK. THEREFORE, THE PHYSICIAN REMOVED THE PX SLIM AND SUCCESSFULLY COMPLETED THE PROCEDURE USING ANOTHER MICROCATHETER, THE SAME GUIDE CATHETER AND NEW COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7088071 ↗
• MalfunctionOct 3, 2017Physical Resistance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA COIL 400'S (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED TWO PC400S INTO THE TARGET VESSEL USING THE PX SLIM WITH NO ISSUES. WHILE ATTEMPTING TO ADVANCE A NEW PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PC400 BECAME STUCK. THEREFORE, THE PHYSICIAN REMOVED THE PX SLIM WITH THE PC400 AND COMPLETED THE PROCEDURE USING A NON-PENUMBRA MICROCATHETER AND PENUMBRA SMART COILS (SMART COILS). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6909918 ↗
• MalfunctionJun 23, 2017Stretched; Device Operates Differently Than Expected; Difficult to Advance; Stretched; Device Operates Differently Than Expected; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE VERTEBRAL ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT WAS NOTED THAT THE ANATOMY WAS REALLY DIFFICULT WITH THE PATIENT. DURING THE PROCEDURE, AFTER ADVANCING A PX SLIM TO THE TREATMENT SITE USING A NEURON MAX, THE PX SLIM KICKED OUT WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE IT INTO THE ANEURYSM; THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE PX SLIM FOR REPOSITIONING. UPON PULLING THE PX SLIM OUT OF THE ROTATING HEMOSTASIS VALVE (RHV), THE PHYSICIAN NOTICED THAT THE PX SLIM STRAIN RELIEF WAS STRETCHED. THEREFORE, THE PX SLIM WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM AND THE SAME NEURON MAX WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6663880 ↗
• MalfunctionFeb 23, 2017Break; Physical Resistance; Compatibility Problem; Break; Physical Resistance; Compatibility Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A POPLITEAL ANEURYSM USING PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PX SLIM THROUGH ANOTHER MANUFACTURER¿S CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PX SLIM WOULD NOT ADVANCE THROUGH THE CATHETER; THEREFORE, IT WAS REMOVED. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE TIP OF THE PX SLIM WAS BROKEN. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL COILS WITH NO MICROCATHETER. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6353245 ↗
• 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 6258959 ↗
• MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO SACRIFICE A BRANCH OF THE VERTEBRAL ARTERY USING POD4 COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED ANOTHER MANUFACTURER¿S DIAGNOSTIC CATHETER IN THE TARGET VESSEL BEFORE ADVANCING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) THROUGH IT. THE PHYSICIAN THEN SUCCESSFULLY DEPLOYED AND DETACHED TWO PENUMBRA COIL 400'S AND A POD4 COIL IN THE TARGET VESSEL USING THE PX SLIM. AFTER, PLACING THE POD4, THE FLOW WAS SHUT BUT THE PHYSICIAN WANTED TO PLACE A FOURTH COIL TO INSURE TOTAL BLOCKAGE. AFTER, PLACING THE POD4, THE FLOW WAS SHUT BUT THE PHYSICIAN WANTED TO PLACE A FOURTH COIL TO INSURE TOTAL BLOCKAGE. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER POD4 INTO THE TARGET VESSEL. IT WAS REPORTED THAT THE PX SLIM FLIPPED INTO A LOOP INSIDE THE VERTEBRAL VESSEL AND THE PHYSICIAN ATTEMPTED PULLING IT BACK TO STRAIGHTEN IT OUT. HOWEVER, THE PX SLIM WOULD NOT STRAIGHTEN UNTIL THE DIAGNOSTIC CATHETER WAS SLID OVER IT. AT SOME POINT DURING THE REPOSITIONING OF THE SYSTEM, THE POD4 UNINTENTIONALLY DETACHED, WITH MOST OF THE COIL STILL INSIDE THE PX SLIM. THE PHYSICIAN THEN WEDGED THE PUSHER ASSEMBLY ALONGSIDE THE POD4, THE PX SLIM, AND

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6125360 ↗
• 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: Occlusion

  MAUDE report 6038519 ↗
• MalfunctionOct 11, 2016Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400''S (PC400''S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN DECIDED TO RETRACT THE PC400 DUE TO INCORRECT SIZING; HOWEVER, UPON RETRACTION, THE PC400 BECAME STUCK IN THE PX SLIM. THE PHYSICIAN THEN REMOVED THE PX SLIM TO REMOVE THE STUCK PC400 AND NOTICED THAT THE TIP OF THE PX SLIM HAD AN ACCORDION-LIKE COMPRESSION DAMAGE. THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM AND ADDITIONAL PC400S. 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 6019356 ↗
• MalfunctionJun 23, 2016Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE REPOSITIONING THE PX SLIM IN THE PATIENT UNDER FLUOROSCOPY WITHOUT EXPERIENCING ANY RESISTANCE, THE PHYSICIAN NOTICED IT WAS BROKEN IN THE MID-SHAFT. THE BROKEN PX SLIM WAS REMOVED FROM THE PATIENT 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 5745360 ↗
• MalfunctionMay 19, 2016Mechanical Problem; Physical Resistance; Device Operates Differently Than Expected; Mechanical Problem; Physical Resistance; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ATTEMPTING TO INSERT A RUBY COIL INTO THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE COIL WAS UNABLE TO BE INSERTED. THEREFORE, THE PX SLIM WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED 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 5668061 ↗
• MalfunctionApr 27, 2016Kinked; Device Handling Problem; Kinked; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND RUBY COILS. DURING THE PROCEDURE, UPON INSERTING A PX SLIM 90 DEGREES IN THE PATIENT, THE PHYSICIAN NOTICED THAT IT WAS NOT THE CORRECT ANGLE; THEREFORE, IT WAS EXCHANGED FOR A PX SLIM 45 DEGREES WHILE ADVANCING A RUBY COIL THROUGH THE PX SLIM 45 DEGREES, THE PX SLIM 45 DEGREES BECAME KINKED; THIS IN TURN CAUSED THE RUBY COIL TO UNINTENTIONALLY DETACH WITHIN THE PX SLIM 45 DEGREES THE PX SLIM 45 DEGREES AND DETACHED RUBY COIL WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS WITH A NEW PX SLIM STRAIGHT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5613422 ↗
• MalfunctionFeb 18, 2016Physical Resistance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE A2 SEGMENT OF THE CEREBRAL ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS), A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND PENUMBRA COIL DETACHMENT HANDLES (HANDLE). DURING THE PROCEDURE, WHILE ADVANCING A PC400 COIL (LOT # F63825) THROUGH THE PX SLIM, THE PHYSICIAN MET RESISTANCE AND DECIDED TO REMOVE BOTH THE PX SLIM AND THE PC400 COIL. AFTER REMOVING BOTH DEVICES FROM THE PATIENT, THE PHYSICIAN NOTICED THAT THE PC400 COIL WAS DAMAGED AND HAD UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY. A NEW PC400 COIL (LOT # F63825) WAS THEN DEPLOYED INTO THE ANEURYSM USING A NEW PX SLIM WITHOUT ANY ISSUES; HOWEVER, THE PHYSICIAN HAD DIFFICULTY DETACHING THE PC400 COIL IN THE ANEURYSM USING THE HANDLE (LOT # F31442). AFTER THREE UNSUCCESSFUL ATTEMPTS TO DETACH THE PC400 COIL USING THE HANDLE, THE PHYSICIAN ATTEMPTED TO USE A NEW HANDLE (LOT # F31442) BUT WAS STILL UNSUCCESSFUL. THE PC400 COIL WAS THEN DETACHED MANUALLY BY THE PHYSICIAN. ANOTHER PC400 COIL (LOT # F36541) WAS THEN DEPLOYED INTO THE ANEURYSM; HOWEVER, THE PHYSICIAN WAS UNABLE TO DETACH THE COIL USING THE HANDLE AND DECIDED TO MANUALLY DETACH THE COIL. THE PRO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5445461 ↗
• MalfunctionFeb 17, 2016Kinked; Physical Resistance; Material Deformation; Kinked; Physical Resistance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR A CORONARY FISTULA USING RUBY COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ACCESSING THE FISTULA; HOWEVER, AFTER MANIPULATION, THE PHYSICIAN WAS ABLE TO GAIN ACCESS AND ADVANCE THE PX SLIM INTO THE TARGET VESSEL. WHILE ADVANCING A RUBY COIL THROUGH THE PX SLIM, THE PHYSICIAN MET RESISTANCE AND NOTICED A KINK ON THE PX SLIM. THE PHYSICIAN CONTINUED TO FORCEFULLY ADVANCE THE RUBY COIL THROUGH THE PX SLIM. SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THE PHYSICIAN DECIDED TO REMOVE THE PX SLIM CONTAINING THE RUBY COIL FROM THE PATIENT AND PLANNED TO TREAT THE PATIENT IN THREE MONTHS. AFTER REMOVING THE DEVICES, THE PHYSICIAN NOTICED THAT THE TIP OF THE PX SLIM WAS DAMAGED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5442572 ↗
• InjuryFeb 16, 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 MIDDLE CEREBRAL ARTERY (MCA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PATIENT EXPERIENCED A TRANSITORY VASOSPASM IN THE INTERNAL CAROTID ARTERY. THE PX SLIM WAS EXCHANGED FOR ANOTHER MANUFACTURER'S MICROCATHETER AND THE TRANSITORY VASOSPASM WAS RESOLVED. THE TRANSITORY VASOSPASM WAS ADJUDICATED TO HAVE A POSSIBLE RELATIONSHIP TO THE PX SLIM, PROBABLE RELATIONSHIP TO THE ANGIOGRAPHIC PROCEDURE AND UNRELATED RELATIONSHIP TO THE ANEURYSM DISEASE STATE.

  Patient problems: Vasoconstriction

  MAUDE report 5439819 ↗
• MalfunctionJan 14, 2016Device Operational Issue; Device Operational Issue

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED THREE RUBY COILS INTO THE ANEURYSM USING THE PX SLIM. WHILE ATTEMPTING TO DELIVER A NEW RUBY COIL INTO THE PATIENT, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE RUBY COIL OUT OF THE PX SLIM AND DECIDED TO REMOVE THE COIL. WHILE THE RUBY COIL WAS BEING REMOVED, IT UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THE RUBY COIL WAS CONTAINED IN THE PX SLIM AND BOTH WERE SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM AND ANOTHER MANUFACTURER'S DEVICES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5367296 ↗
• 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 5342428 ↗
• MalfunctionJan 4, 2016Activation, Positioning or Separation Problem; Device Operational Issue; Activation, Positioning or Separation Problem; Device Operational Issue

  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 5342374 ↗
• MalfunctionDec 9, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND PX SLIM DELIVERY MICROCATHETERS (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING TWO RUBY COILS (LOT #F63538) THROUGH A PX SLIM, BOTH RUBY COIL PUSHER ASSEMBLIES BECAME KINKED. THE PHYSICIAN REMOVED THE TWO RUBY COILS AND THE PX SLIM FROM THE PATIENT AND THEN SUCCESSFULLY DEPLOYED AND DETACHED SEVEN NEW RUBY COILS INTO THE ANEURYSM USING A NEW PX SLIM. NEXT, THE PHYSICIAN ATTEMPTED TO DELIVER A NEW RUBY COIL (LOT #F65516) INTO THE ANEURYSM; HOWEVER, THE RUBY COIL STOPPED ADVANCING THROUGH THE PX SLIM AND THE PHYSICIAN DECIDED TO REMOVE THE COIL. WHILE REMOVING THE RUBY COIL, IT UNINTENTIONALLY DETACHED INSIDE THE PX SLIM AND BECAME STRETCHED. THE PHYSICIAN REMOVED BOTH THE PX SLIM AND THE STRETCHED RUBY COIL FROM THE PATIENT. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5283934 ↗
• MalfunctionDec 9, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND PX SLIM DELIVERY MICROCATHETERS (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING TWO RUBY COILS (LOT #F63538) THROUGH A PX SLIM, BOTH RUBY COIL PUSHER ASSEMBLIES BECAME KINKED. THE PHYSICIAN REMOVED THE TWO RUBY COILS AND THE PX SLIM FROM THE PATIENT AND THEN SUCCESSFULLY DEPLOYED AND DETACHED SEVEN NEW RUBY COILS INTO THE ANEURYSM USING A NEW PX SLIM. NEXT, THE PHYSICIAN ATTEMPTED TO DELIVER A NEW RUBY COIL (LOT #F65516) INTO THE ANEURYSM; HOWEVER, THE RUBY COIL STOPPED ADVANCING THROUGH THE PX SLIM AND THE PHYSICIAN DECIDED TO REMOVE THE COIL. WHILE REMOVING THE RUBY COIL, IT UNINTENTIONALLY DETACHED INSIDE THE PX SLIM AND BECAME STRETCHED. THE PHYSICIAN REMOVED BOTH THE PX SLIM AND THE STRETCHED RUBY COIL FROM THE PATIENT. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5283692 ↗
• MalfunctionDec 8, 2015Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING THE FIRST TWO RUBY COILS THROUGH THE PX SLIM, THE PHYSICIAN MET RESISTANCE AND BOTH COILS WERE REMOVED FROM THE PATIENT. WHILE ATTEMPTING TO RESHEATH THE TWO RUBY COILS, THEY BOTH BECAME DAMAGED AND WERE NOT USED. THE PHYSICIAN REMOVED THE PX SLIM AND SUCCESSFULLY COMPLETED THE PROCEDURE USING NINE NEW RUBY COILS 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 5275664 ↗
• MalfunctionOct 16, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND POD COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DELIVERED THE PX SLIM INTO THE VERTEBRAL ARTERY BUT WAS UNABLE TO ADVANCE TWO DIFFERENT POD COILS THROUGH THE PX SLIM. THE PX SLIM AND POD COILS WERE REMOVED FROM THE PATIENT AND THE PROCEDURE CONTINUED USING ANOTHER MANUFACTURER'S DEVICES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5157925 ↗
• MalfunctionSep 29, 2015Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND RUBY COILS. AFTER SUCCESSFULLY DEPLOYING AND DETACHING RUBY COILS IN THE ANEURYSM, THE PHYSICIAN MET RESISTANCE WHILE ADVANCING A NEW RUBY COIL THROUGH THE PX SLIM. WHILE ATTEMPTING TO WITHDRAW THE RUBY COIL FROM THE PX SLIM, THE RUBY COIL UNINTENTIONALLY DETACHED. BOTH RUBY COIL AND PX SLIM WERE REMOVED FROM THE PATIENT. THE PROCEDURE SUCCESSFULLY CONTINUED USING A NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5110697 ↗