PX SLIM Delivery Microcatheter PXSLIMSTR-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00814548016443), received between Oct 26, 2015 and May 17, 2024 — classified as 46 malfunctions.

The most frequently reported specific device problem is “Physical Resistance” (19 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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY (BA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE PX SLIM TO THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE AND FRACTURED THE PX SLIM AT THE HUB. THEREFORE, THE PX SLIM WAS REMOVED AND WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA MICROCATHETER AND NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19347197 ↗
• MalfunctionDec 20, 2023Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RIGHT ARTERIOVENOUS FISTULA (AVF) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED PENUMBRA COIL 400S (PC400) IN THE TARGET VESSEL THEN DELIVERED A LIQUID EMBOLIC AGENT INTO THE TARGET VESSEL USING THE PX SLIM. AFTER REMOVAL OF THE PX SLIM, THE PHYSICIAN NOTICED THAT THE TIP OF THE PX SLIM HAD FRACTURED AND WAS EMBEDDED SECURELY INSIDE THE PC400 COIL PACK. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361702 ↗
• MalfunctionJun 30, 2023Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT CAROTID ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS OPENING THE VALVE OF THE GUIDE CATHETER AND THE PX SLIM BROKE AT THE MID-SHAFT INTO TWO PIECES INSIDE OF THE GUIDE CATHETER. IT WAS ALSO REPORTED THAT THE BLOOD FLOW PUSHED THE BROKEN PX SLIM OUT FROM THE GUIDE CATHETER AND THE BROKEN PIECE OF THE PX SLIM WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NON-PENUMBRA MICROCATHETER AND THE SAME GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17240097 ↗
• MalfunctionJun 12, 2023Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL CAROTID ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM), PENUMBRA COIL 400 (PC400), AND A BENCHMARK BMX 81 ACCESS SYSTEM (BMX81). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400, THE PHYSICIAN FELT SOMETHING. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE PX SLIM AND THE PC400. UPON REMOVAL, THE PX SLIM WAS NOTICED TO BE FRACTURED INTO TWO PIECES AT THE PROXIMAL END. IT WAS REPORTED THAT THE PUSHER ASSEMBLY OF THE PC400 HAD BRIDGED BETWEEN THE TWO FRACTURED PIECES OF THE PX SLIM ALLOWING THE PHYSICIAN TO REMOVE THE PC400 INTACT AND THE PX SLIM TOGETHER. IT WAS ALSO REPORTED THAT THE DECISION WAS MADE TO NOT USE THE REMOVED PC400 AND THERE WAS NO DAMAGE NOTED TO THE PC400. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM, A NEW PC400, AND THE SAME BMX81. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17106370 ↗
• MalfunctionNov 2, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND PENUMBRA COIL 400S (PC400S). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A PC400 INTO THE PX SLIM, THE PC400 BECAME STUCK. THEREFORE, THE PC400 WAS REMOVED. NEXT, WHILE ADVANCING A NEW PC400 INTO THE PX SLIM, THE SAME ISSUE OCCURRED, THE PC400 BECAME STUCK. THEREFORE, THE PC400 AND THE PX SLIM WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW PC400S AND 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 12741066 ↗
• MalfunctionJun 16, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE PX SLIM. THEREFORE, THE PX SLIM WAS REMOVED. UPON REMOVAL, IT WAS NOTED THAT THE PROXIMAL END OF THE PX SLIM WAS BROKEN. 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 12014224 ↗
• MalfunctionJun 16, 2021Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT PELVIC VARICOSE VEINS USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM), A RUBY COIL, NON-PENUMBRA CATHETER AND A NON-PENUMBRA INTRODUCER SHEATH. DURING THE PROCEDURE, A PX SLIM WAS PASSED THROUGH A CATHETER TO THE PELVIC VARICOSE VEINS. NEXT, A RUBY COIL AND POLIDOCANOL WERE PLACED SUCCESSFULLY IN THE DISTAL PORTION OF THE TARGET LOCATION USING THE PX SLIM. AFTERWARDS, THE PHYSICIAN ADVANCED THE CATHETER TO THE GONADAL VEIN AND SUBSEQUENTLY, WHILE ADVANCING APPROXIMATELY FIVE CENTIMETERS OF THE PX SLIM THROUGH THE RHV OF THE CATHETER, PART OF THE PX SLIM THAT WAS OUTSIDE THE PATIENT BROKE. THEREFORE, THE BROKEN PX SLIM WAS REMOVED BY PULLING IT OUT BY HAND. AFTER THE REMOVAL, WHILE THE PHYSICIAN EXAMINED THE BROKEN PX SLIM, THE PHYSICIAN FURTHER BROKE THE PX SLIM INTO TWO ADDITIONAL PIECES. IT WAS REPORTED THAT THE PX SLIM WAS DRY. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM AND THE SAME INTRODUCER SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12013692 ↗
• MalfunctionMar 9, 2021Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEMORRHOIDAL ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM), A NON-PENUMBRA DIAGNOSTIC CATHETER AND A MICRO-GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE PX SLIM OVER A GUIDEWIRE THROUGH THE DIAGNOSTIC CATHETER TO THE PATIENT¿S TARGET VESSEL DUE TO THE PATIENT¿S TORTUOUS ANATOMY. UPON INJECTING CONTRAST, THE PHYSICIAN WAS UNABLE TO SEE THE PATIENT¿S VESSEL DUE TO THE CONTRAST PASSING THROUGH THE DIAGNOSTIC CATHETER AND NOT THROUGH THE PX SLIM. SUBSEQUENTLY, IT WAS NOTICED THAT ONE THIRD OF THE PROXIMAL END NEAR THE HUB OF THE PX SLIM WAS FRACTURED. THEREFORE, THE PHYSICIAN REMOVED THE PX SLIM ALONG WITH THE DIAGNOSTIC CATHETER. IT WAS REPORTED THAT WHILE THE PHYSICIAN REMOVED THE PX SLIM, THE PHYSICIAN FURTHERED FRACTURED THE PX SLIM. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA MICROCATHETER AND THE SAME DIAGNOSTIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11446145 ↗
• MalfunctionOct 29, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA COIL 400 (PC400) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING THE PC400 THROUGH THE PX SLIM AND INTO THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PC400 BECAME STUCK IN THE PX SLIM. THEREFORE, PX SLIM AND PC400 WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PX SLIM AND ADDITIONAL PC400S. 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 10758252 ↗
• MalfunctionAug 7, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, IT WAS REPORTED THAT THE PX SLIM AND TWO SMART COILS WERE "DEFECTIVE". NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10382947 ↗
• MalfunctionAug 5, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING POD COILS AND PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A POD COIL THROUGH THE PX SLIM. SUBSEQUENTLY, THE POD COIL WAS NOT TAKING ITS INTENDED SHAPE OR ANCHORING WITHIN THE VESSEL. THE PHYSICIAN THEREFORE DECIDED TO REMOVE THE POD COIL; HOWEVER, WHILE RETRACTING, THE POD COIL UNINTENTIONALLY DETACHED INSIDE OF THE PX SLIM. THEREFORE, THE PX SLIM WAS REMOVED CONTAINING THE DETACHED POD COIL. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL AND NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10368878 ↗
• MalfunctionMar 26, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID CAVERNOUS FISTULA (CCF) IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA COIL 400 (PC400) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A PC400 INTO THE TARGET VESSEL USING THE PX SLIM. UPON REMOVAL OF THE PUSHER ASSEMBLY, IT WAS NOTICED THAT THE PUSHER ASSEMBLY BROKE INTO TWO PIECES, LEAVING A BROKEN PIECE STUCK WITHIN THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE BROKEN PIECE OF THE PUSHER ASSEMBLY WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400S 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 9886559 ↗
• MalfunctionNov 22, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  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 9365064 ↗
• 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 9307013 ↗
• MalfunctionSep 6, 2019Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT ARTERIAL SUBCLAVIAN ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE PX SLIM THROUGH THE ROTATING HEMOSTASIS VALVE (RHV) AND INTO A NON-PENUMBRA SHEATH, THE PHYSICIAN NOTICED THE PROXIMAL END OF THE PX SLIM BROKE IN THREE PLACES WITHIN THE RHV BUT REMAINED INTACT. THE PX SLIM WAS THEREFORE 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 8970092 ↗
• MalfunctionApr 26, 2019Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, PRIOR TO ADVANCEMENT INTO THE PATIENT, THE PHYSICIAN WAS ADVANCING THE PX SLIM OVER THE GUIDEWIRE AND NOTICED THAT THE PX SLIM WAS BROKEN AT THE DISTAL END. THE PX SLIM WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8557434 ↗
• MalfunctionMar 28, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY 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 SUBSEQUENTLY, THE PC400 WOULD NOT ADVANCE BEYOND THE MID SHAFT OF THE PX SLIM. THE PC400 AND PX SLIM WERE THEN REMOVED, AND 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 8461215 ↗
• MalfunctionDec 21, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400S (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO PC400S THROUGH THE PX SLIM. THEREFORE, THE PC400S AND PX SLIM WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW PC400S 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 8190157 ↗
• MalfunctionDec 6, 2017Physical Resistance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400''S (PC400''S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN PLACED THE PX SLIM INTO THE DISTAL END OF THE RIGHT IIA (SUPERIOR GLUTEAL ARTERY AND BIFURCATION OF INFERIOR GLUTEAL ARTERY), THEN DEPLOYED AND DETACHED SIX PC400''S INTO THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE A NEW PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE WHEN THE COIL WAS ADVANCED MIDWAY THROUGH THE PX SLIM. SUBSEQUENTLY, THE PC400 PUSHER ASSEMBLY BECAME KINKED WHEN THE PHYSICIAN USED A LITTLE FORCE IN AN ATTEMPT TO ADVANCE THE COIL FURTHER. THEREFORE, THE PHYSICIAN REMOVED BOTH THE PX SLIM AND THE PC400 FROM THE PATIENT¿S BODY. THE PROCEDURE WAS THEN COMPLETED USING A NEW PX SLIM AND THREE ADDITIONAL PC400''S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7089270 ↗
• MalfunctionSep 26, 2017Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400'S (PC400'S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO NON-PENUMBRA COILS USING THE PX SLIM. THE PHYSICIAN THEN FELT RESISTANCE ADVANCING A PC400 THROUGH THE PX SLIM, AND THE PC400 BECAME STUCK. THE PHYSICIAN ATTEMPTED TO FORCEFULLY RETRACT THE PC400; CONSEQUENTLY, THE PC400 COIL BROKE. THE PHYSICIAN THEREFORE REMOVED THE PX SLIM WITH THE PC400 INSIDE. THE PROCEDURE WAS THEN COMPLETED USING A NEW MICROCATHETER AND A NEW PC400. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6895416 ↗
• MalfunctionJun 6, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ABDOMINAL AORTIC ARTERY (AAA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE PX SLIM THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AT THE HUB OF THE MICROCATHETER. THEREFORE, THE PX SLIM WAS REMOVED AND THE EMBOLIZATION WAS SUCCESSFULLY COMPLETED USING A NEW MICROCATHETER AND ADDITIONAL COILS. THEREAFTER, THE PROCEDURE SHIFTED TO A STENT-GRAFTING AND WAS COMPLETED WITHOUT ANY ISSUES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6614529 ↗
• MalfunctionMar 31, 2017Retraction Problem; Failure to Advance; Physical Resistance; Retraction Problem; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (P-AVM) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, AFTER ADVANCING THE PX SLIM APPROXIMATELY FIFTY CENTIMETERS THROUGH A NON-PENUMBRA PARENT CATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE OR RETRACT THE PX SLIM. THEREFORE, THE PARENT CATHETER WAS REMOVED WITH THE PX SLIM STILL INSIDE. THE PROCEDURE WAS THEN COMPLETED USING A NEW NON-PENUMBRA PARENT CATHETER AND A PLUG. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO REMOVE THE PX SLIM FROM THE PARENT CATHETER AFTER THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6451378 ↗
• MalfunctionMar 28, 2017Kinked; Physical Resistance; Kinked; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BRACHIOCEPHALIC ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN PLACED ANOTHER MANUFACTURER¿S CATHETER IN THE TARGET VESSEL AND ATTEMPTED TO ADVANCE A PX SLIM THROUGH IT; HOWEVER, RESISTANCE WAS ENCOUNTERED AND SUBSEQUENTLY, THE PX SLIM BECAME KINKED AT THE MID-SHAFT. THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW PX SLIM THROUGH THE CATHETER; HOWEVER RESISTANCE WAS ENCOUNTERED AGAIN AND THE PX SLIM BECAME KINKED AT THE MID-SHAFT. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURE¿S MICROCATHETER, THE SAME CATHETER AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6439380 ↗
• MalfunctionMar 28, 2017Kinked; Physical Resistance; Kinked; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BRACHIOCEPHALIC ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN PLACED ANOTHER MANUFACTURER¿S CATHETER IN THE TARGET VESSEL AND ATTEMPTED TO ADVANCE A PX SLIM THROUGH IT; HOWEVER, RESISTANCE WAS ENCOUNTERED AND SUBSEQUENTLY, THE PX SLIM BECAME KINKED AT THE MID-SHAFT. THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW PX SLIM THROUGH THE CATHETER; HOWEVER RESISTANCE WAS ENCOUNTERED AGAIN AND THE PX SLIM BECAME KINKED AT THE MID-SHAFT. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURE¿S MICROCATHETER, THE SAME CATHETER AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6439376 ↗
• MalfunctionMar 27, 2017Physical Resistance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT TRANSVERSE SINUS VENOUS USING PENUMBRA COIL 400'S (PC400'S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA GUIDE CATHETER AND A NON-PENUMBRA MICROCATHETER INTO THE TARGET VESSEL AND THEN IMPLANTED EIGHT NON-PENUMBRA COILS. NEXT, THE PHYSICIAN SWITCHED TO THE PX SLIM AND ATTEMPTED TO ADVANCE A PC400 THROUGH IT. WHILE ATTEMPTING TO ADVANCE THE PC400, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THE PC400 OUT OF ITS INTRODUCER SHEATH AND INTO THE PX SLIM. THEREFORE, THE INTRODUCER SHEATH CONTAINING THE PC400 WAS REMOVED AND A NEW PC400 WAS OPENED. WHILE ATTEMPTING TO ADVANCE THE NEW PC400 THROUGH THE SAME PX SLIM, THE PHYSICIAN ENCOUNTERED RESISTANCE AFTER ADVANCING THE COIL APPROXIMATELY ONE HUNDRED CENTIMETERS THROUGH THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE PC400 WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING AN ADDITIONAL COIL AND A NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6437870 ↗