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PX SLIM Delivery Microcatheter PXSLIM090-BRecalls & reported problems

Penumbra, Inc. · PXSLIM 150Micro, 90Deg · Class 2

All models of PX SLIM Delivery Microcatheter (9)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
15
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00814548012520), received between Aug 28, 2015 and Feb 28, 2020 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Physical Resistance” (5 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

Device problems

  • Physical Resistance5
  • Adverse Event Without Identified Device or Use Problem3
  • Device Operates Differently Than Expected2
  • Failure to Advance2
  • Fracture2
  • Mechanical Problem2
  • Physical Resistance/Sticking2
  • Difficult to Insert1

Patient problems

  • No Consequences Or Impact To Patient14
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 28, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA COIL 400S (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING THE PC400 THROUGH THE PX SLIM THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE PC400. HOWEVER, UPON RETRACTION, THE PC400 HAD UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THEREFORE, THE PHYSICIAN REMOVED THE PX SLIM CONTAINING THE DETACHED PC400 AND THEN FLUSHED OUT THE PC400. THE PHYSICIAN THEN REINSERTED THE SAME MICROCATHETER AND ATTEMPTED TO ADVANCE ANOTHER PC400; HOWEVER, THE SAME ISSUE OCCURRED, AND THE PC400 UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE DETACHED PC 400 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 9767782 ↗
  • 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 9365110 ↗
  • MalfunctionNov 4, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE WITH STENT ASSIST IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COILS 400 (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, A NON-PENUMBRA STENT WAS PLACED ACROSS THE ANEURYSM, FOLLOW BY THE PX SLIM AND A NON-PENUMBRA MICROCATHETER, WHICH WERE ADVANCED THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). THE PHYSICIAN THEN SUCCESSFULLY PLACED TWO PC400S IN THE ANEURYSM USING THE PX SLIM. WHILE ADVANCING THE NEXT PC400 THROUGH THE PX SLIM IN THE ANEURYSM, IT WAS NOTICED THAT THE PC400 WAS TOO LONG; THE PHYSICIAN EXPERIENCED RESISTANCE AND PART OF THE PC400 BEGAN FALLING OUT OF THE ANEURYSM AND DOWN INTO THE PARENT VESSEL. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO PARTIALLY RETRACT THE PX SLIM TO REMOVE THE PC400. UPON REMOVAL OF THE PC400, THE PHYSICIAN NOTICED IT WAS STRETCHED WITH THE COIL WINDS VISIBLE. NEXT, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE DISTAL MARKER ON THE PX SLIM WAS LOCATED OUTSIDE THE ANEURYSM; THEREFORE, THE PHYSICIAN CONTINUED RETRACTING THE PX SLIM OUT FROM BETWEEN THE STENT AND THE TARGET VESSEL AND ATTEMPTED TO RECANNULATE THE ANEURYSM THROUGH THE STENT, B

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9275956 ↗
  • MalfunctionSep 14, 2018Mechanical Problem; Mechanical Problem

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COILS 400 AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL THROUGH A PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE JUST BEFORE THE SMART COIL CAME OUT THE TIP OF THE PX SLIM; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER PC400; THEREFORE, THE PX SLIM AND PC400 WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM, OTHER COILS AND FOUR NEW PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7877648 ↗
  • MalfunctionMar 9, 2018Fracture; Physical Resistance; Fracture; Physical Resistance

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY (IIA) TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AFTER ADVANCING THE PX SLIM ABOUT 15-20 CM INTO THE NON-PENUMBRA SHEATH. THE PHYSICIAN THEN FELT RESISTANCE WHILE RETRACTING TO REMOVE THE PX SLIM, AND THEREFORE THE SHEATH WAS REMOVED WITH THE PX SLIM INSIDE. UPON REMOVAL, THE PHYSICIAN SAW THAT THE TIP OF THE PX SLIM WAS FRACTURED. THE PROCEDURE WAS COMPLETED USING A NEW SHEATH 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 7327223 ↗
  • MalfunctionAug 4, 2017Physical Resistance; Physical Resistance

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CELIAC ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA CATHETER TOWARDS THE CELIAC ARTERY AND THEN THE PX SLIM THROUGH THE CATHETER. WHILE ATTEMPTING TO ADVANCE A PENUMBRA COIL 400 (PC400) THROUGH THE PX SLIM, THE PHYSICIAN ENCOUNTERED RESISTANCE AFTER ADVANCING THE COIL APPROXIMATELY THIRTY TO FORTY CENTIMETERS THROUGH THE PX SLIM. THEREFORE, THE PC400 AND PX SLIM WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER MICROCATHETER, THE SAME PC400 AND SEVEN ADDITIONAL PC400'S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6769445 ↗
  • MalfunctionAug 2, 2017Physical Resistance; Device Operates Differently Than Expected; Physical Resistance; Device Operates Differently Than Expected

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY (IIA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE PX SLIM TOWARDS THE TARGET VESSEL AND THEN ATTEMPTED TO ADVANCE AN INITIAL POD4 THROUGH THE PX SLIM. WHILE ADVANCING THE POD4 APPROXIMATELY TEN CENTIMETERS INTO THE PX SLIM, THE PHYSICIAN ENCOUNTERED RESISTANCE AND RETRACTED THE COIL. THE PX SLIM WAS THEN FLUSHED AND ANOTHER ATTEMPT WAS MADE TO ADVANCE THE SAME POD4 THROUGH THE PX SLIM; HOWEVER, RESISTANCE WAS MET AGAIN AND THE PHYSICIAN REMOVED THE PX SLIM CONTAINING THE POD4. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED USING A NEW PX SLIM, THE SAME POD4 AND AN ADDITIONAL PENUMBRA COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6760322 ↗
  • MalfunctionNov 3, 2016Difficult to Insert; Physical Resistance; Difficult to Insert; Physical Resistance

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING INSERT THE PX SLIM INTO A NON-PENUMBRA MICROCATHETER AND THE PX SLIM WAS UNABLE TO BE INSERTED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM WITH THE SAME NON-PENUMBRA CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6076012 ↗
  • MalfunctionOct 4, 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 CEREBRAL ARTERY USING PENUMBRA COIL 400'S (PC400'S) AND PX SLIM DELIVERY MICROCATHETERS (PX SLIM). IT WAS REPORTED THAT THE PATIENT HAD EXCESSIVELY TORTUOUS VESSELS IN THE ABDOMINAL PART. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA GUIDING SHEATH TOWARD THE LEFT COMMON CAROTID ARTERY AND THEN INSERTED A NON-PENUMBRA MICROCATHETER TO THE DISTAL PORTION OF THE TARGET ANEURYSM IN ORDER TO PLACE A STENT DEVICE TO PREVENT BACK FLOW. AFTER THE STENT WAS PLACED, THE NON-PENUMBRA MICROCATHETER WAS REMOVED AND A PX SLIM WAS ADVANCED INTO THE TARGET ANEURYSM. THE PHYSICIAN THEN ATTEMPTED TO DEPLOY AND DETACH THE FIRST PC400; HOWEVER, THE PHYSICIAN WAS UNABLE TO DETACH THE PC400 USING A PENUMBRA COIL DETACHMENT HANDLE (HANDLE). THE HANDLE MADE ITS USUAL CLICKING SOUND AND THERE WERE NO VISIBLE DAMAGES TO THE HANDLE. SUBSEQUENTLY, THE PHYSICIAN BROKE THE PROXIMAL END OF THE PUSHER ASSEMBLY WITH HIS HANDS AND ATTEMPTED TO RETRACT THE PULL WIRE USING FORCEPS. HOWEVER, DURING THIS PROCESS, ALTHOUGH THE PHYSICIAN DID NOT MENTION ANY RESISTANCE, THE PC400 UNINTENTIONALLY DETACHED THREE HUNDRED AND EIGHTY-FIVE MILLIMETER

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5998709 ↗
  • MalfunctionOct 4, 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 CEREBRAL ARTERY USING PENUMBRA COIL 400''S (PC400''S) AND PX SLIM DELIVERY MICROCATHETERS (PX SLIM). IT WAS REPORTED THAT THE PATIENT HAD EXCESSIVELY TORTUOUS VESSELS IN THE ABDOMINAL PART. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA GUIDING SHEATH TOWARD THE LEFT COMMON CAROTID ARTERY AND THEN INSERTED A NON-PENUMBRA MICROCATHETER TO THE DISTAL PORTION OF THE TARGET ANEURYSM IN ORDER TO PLACE A STENT DEVICE TO PREVENT BACK FLOW. AFTER THE STENT WAS PLACED, THE NON-PENUMBRA MICROCATHETER WAS REMOVED AND A PX SLIM WAS ADVANCED INTO THE TARGET ANEURYSM. THE PHYSICIAN THEN ATTEMPTED TO DEPLOY AND DETACH THE FIRST PC400; HOWEVER, THE PHYSICIAN WAS UNABLE TO DETACH THE PC400 USING A PENUMBRA COIL DETACHMENT HANDLE (HANDLE). THE HANDLE MADE ITS USUAL CLICKING SOUND AND THERE WERE NO VISIBLE DAMAGES TO THE HANDLE. SUBSEQUENTLY, THE PHYSICIAN BROKE THE PROXIMAL END OF THE PUSHER ASSEMBLY WITH HIS HANDS AND ATTEMPTED TO RETRACT THE PULL WIRE USING FORCEPS. HOWEVER, DURING THIS PROCESS, ALTHOUGH THE PHYSICIAN DID NOT MENTION ANY RESISTANCE, THE PC400 UNINTENTIONALLY DETACHED THREE HUNDRED AND EIGHTY-FIVE MILLIMET

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5998702 ↗
  • MalfunctionAug 31, 2016Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR A RENAL ARTERIOVENOUS MALFORMATION (AVM) USING PENUMBRA COIL 400'S (PC400'S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN FIRST ADVANCED AND INFLATED ANOTHER MANUFACTURER'S BALLOON CATHETER NEAR THE SHUNT POINT OF THE AVM IN ORDER TO CONTROL BLOOD FLOW. THE PX SLIM WAS THEN ADVANCED THROUGH THE BALLOON CATHETER AND TOWARDS THE OUTFLOW PORTION OF THE SHUNT POINT. NEXT, THE PHYSICIAN ATTEMPTED TO DEPLOY A PC400 INTO THE AVM. HOWEVER, WHILE ADVANCING AND RETRACTING A PC400 THROUGH THE PX SLIM, THE PHYSICIAN ENCOUNTERED RESISTANCE. SUBSEQUENTLY, AFTER SEVERAL ATTEMPTS OF ADVANCING AND RETRACTING THE PC400, THE PHYSICIAN NOTICED THAT THE COIL HAD UNINTENTIONALLY DETACHED WITH APPROXIMATELY TEN CENTIMETERS PROTRUDING FROM THE PX SLIM. THEREFORE, THE PHYSICIAN APPROACHED THE SHUNT POINT FROM THE RIGHT FEMORAL VEIN THROUGH THE RIGHT RENAL VEIN AND REQUIRED A SNARE DEVICE TO RETRIEVE THE DETACHED PC400. SINCE THE RIGHT FEMORAL VEIN WAS PUNCTURED, THE PHYSICIAN INSERTED A BALLOON CATHETER FOR BALLOON-OCCLUDED RETROGRADE TRANSVENOUS OBLITERATION (BRTO) AND WEDGED IT AT THE OUTFLOW PORTION OF TH

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5919680 ↗
  • MalfunctionAug 4, 2016Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem; Device Operates Differently Than Expected

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE 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 A PC400 COIL INTO THE ANEURYSM; HOWEVER, THE COIL MIGRATED TO THE MIDDLE CEREBRAL ARTERY (MCA). THE TIP OF THE PX SLIM WAS STILL IN THE ANEURYSM BUT IT WAS DIFFICULT TO REMOVE THE PC400 COIL FROM THE MCA SO THE PHYSICIAN DECIDED TO REPOSITION THE PX SLIM OUTSIDE OF THE ANEURYSM IN ORDER TO REDUCE RESISTANCE AND DEFLECTION. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE PC400 COIL PUSHER ASSEMBLY BACK THROUGH THE PX SLIM; HOWEVER, THE PC400 COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN CUT OFF THE HUB OF THE PX SLIM AND REQUIRED A SNARE DEVICE TO REMOVE THE DETACHED PC400 COIL FROM THE PATIENT. THE PROCEDURE WAS THEN COMPLETED USING ANOTHER MANUFACTURERS'' COILS AND MICROCATHETER. IT SHOULD BE NOTED THAT THE PHYSICIAN USED A ROTATING HEMOSTASIS VALVE (RHV) AND MAINTAINED A CONTINUOUS FLUSH OF SALINE DURING THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5847315 ↗
  • MalfunctionJun 28, 2016Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUBCLAVIAN ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN INSERTED ANOTHER MANUFACTURER'S ANGIOGRAPHY CATHETER INTO THE TARGET VESSEL AND THEN ATTEMPTED TO ADVANCE THE PX SLIM THROUGH IT. HOWEVER, WHILE ADVANCING THE PX SLIM THROUGH THE ANGIOGRAPHY CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PX SLIM WAS UNABLE TO ADVANCE ANY FURTHER. THEREFORE, THE PX SLIM WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A MICROCATHETER, USING ANOTHER MANUFACTURER'S COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5755340 ↗
  • MalfunctionFeb 25, 2016Fracture; Fracture

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY (IIA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN PLACED A VASCULAR PLUG INTO THE MAIN VESSEL OF THE RIGHT IIA VIA ANOTHER MANUFACTURER'S GUIDING SHEATH AND THEN REMOVED THE VASCULAR PLUG'S DELIVERY SYSTEM. WHILE THE PHYSICIAN WAS ADVANCING THE PX SLIM THROUGH THE GUIDING SHEATH, THE PX SLIM BECAME FRACTURED APPROXIMATELY 15 CENTIMETERS FROM THE HUB AND WAS REMOVED. THE PHYSICIAN DID NOT EXPERIENCE RESISTANCE OR DIFFICULTY WHILE ADVANCING THE PX SLIM. 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 Consequences Or Impact To Patient

    MAUDE report 5462324 ↗
  • MalfunctionAug 28, 2015Adverse Event Without Identified Device or Use Problem

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND PENUMBRA COIL 400 (PC400) COIL. THE PHYSICIAN ADVANCED THE PX SLIM INTO THE ANEURYSM THROUGH A GUIDE CATHETER, AND PLACED A STENT AT THE NECK OF THE ANEURYSM. THE PC400 COIL WAS REPOSITIONED SEVERAL TIMES DURING DEPLOYMENT INTO THE ANEURYSM. WHILE REPOSITIONING, THE PC400 COIL UNINTENTIONALLY DETACHED PARTIALLY INSIDE THE PX SLIM AND PARTIALLY IN THE ANEURYSM. THE PHYSICIAN CUT THE HUB OF THE PX SLIM AND USED A SNARE DEVICE IN AN UNSUCCESSFUL ATTEMPT TO REMOVE THE DETACHED PC400 COIL FROM THE PX SLIM. THE PC400 COIL BECAME DAMAGED AND BEGAN TO UNRAVEL. THE PHYSICIAN REMOVED THE PX SLIM AND ATTEMPTED TO ASPIRATE THE DETACHED COIL THROUGH THE GUIDE CATHETER USING A SYRINGE. SYRINGE ASPIRATION WAS UNSUCCESSFUL, AND THE PHYSICIAN WITHDREW THE GUIDE CATHETER FROM THE PATIENT. THE DETACHED PC400 COIL REMAINED PARTIALLY IN THE ANEURYSM AND PARTIALLY IN THE PARENT VESSEL. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5040338 ↗

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