PhenomTM 27 Catheter FG15160-0615-1S (UDI 00763000399726)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00763000399726), received between Jan 7, 2022 and Jun 22, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN IN THE DISTAL. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED, LEFT PALOPHTHALMIC ANEURYSM WITH A MAX DIAMETER OF 8 MM AND AN 8 MM NECK DIAMETER. THE LANDING ZONE WAS 4.2 MM DISTALLY AND 5 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS SATISFACTORY. IT WAS REPORTED THAT ALL THE PREPARATION WAS FOLLOWED AS INDICATED IN THE PACKAGE INSERT. THE PIPELINE STENT AT THE TIME OF THE IMPLANTATION, DID NOT OPEN AT THE DISTAL PART. MANEUVERS OF REPOSITIONING, CORRECTION OF THE TENSION OF THE DELIVERY SYSTEM, AND OPENING AND RECAPPING OF THE SYSTEM STILL DID NOT OPEN THE STENT. THE STENT WAS REPLACED BY ANOTHER DEVICE. THE PIPELINE WAS STUCK IN THE CAPTURE COIL. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER, AND FROM THE PATIENT. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS NOT APPROVED (OFF-LABEL). THE PIPELINE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25578482 ↗
• MalfunctionApr 6, 2026Retraction Problem; No Apparent Adverse Event

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791807 ↗
• MalfunctionMar 23, 2026Retraction Problem; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL EVENT INFORMATION RECEIVED. IT WAS CONFIRMED THAT THE PUSHWIRE WAS BROKEN. THERE WAS NOT AN ATTEMPT TO DETACH THE COIL ONLY RETRACT AND REPOSITION THE COIL THREE TIMES. THE DETACHER WAS NEVER USED. THE PIPELINE STENT WAS DEPLOYED AND WAS NEVER STUCK. ONLY UPON REMOVING THE "PIPELINE" DELIVERY WIRE DID THE DELIVERY WIRE BECOME STUCK WITHIN THE PHENOM 27 MICROCATHETER. IT WAS A PHENOM 27 NOT A PHENOM 37. ONE PHENOM 27 WAS USED DURING THE PROCEDURE. NO ADVERSE PATIENT EFFECTS OR COMPLICATIONS NOTED. THE EXTREME TORTUOSITY OF THE VESSEL IS A POSSIBLE CAUSE OR CONTRIBUTING FACTOR FOR THE EVENT. THERE WAS NO ISSUE WITH THE COIL EXITING THE MICROCATHETER, BUT POSSIBLE OVALIZATION OF MICROCATHETER COULD HAVE ADDED ADDITIONAL STRESS ON THE COIL JUNCTION BETWEEN COIL AND PUSHER WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24669947 ↗
• MalfunctionFeb 19, 2026Retraction Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF A PIPELINE DEVICE ENCOUNTERED RESISTANCE AND BECAME STUCK IN A PHENOM CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY BRANCH WITH A VESSEL DIAMETER OR 4.5MM. THE ANEURYSM HAD A MAX DIAMETER OF 6.2MM, A 3.8MM NECK DIAMETER, AND A LANDING ZONE OR ARTERY SIZE OF 3.8MM DISTALLY AND 4.5MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUALANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED. NO PROBLEMS WERE FOUND DURING POST-OPERATIVE BLOOD FLOW IMAGING. IT WAS REPORTED THAT THE PRE-PROCEDURAL PREPARATION WAS PERFORMED ACCORDING TO THE INSTRUCTIONS FOR USE. AFTER THE MICROCATHETER (FG 15160-0615-1S) WAS GUIDED TO THE TARGET SITE THEN DELIVERY OF PIPELINE WAS ATTEMPTED. HOWEVER, STRONG RESISTANCE WAS ENCOUNTERED AT THE PROXIMAL PART OF THE CATHETER, MAKING ADVANCEMENT AND WITHDRAWAL IMPOSSIBLE. BOTH PHENOM27 AND PIPELINE WERE REMOVED. WHEN ANOTHER PRODUCT WAS USED, THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. IT WAS NOTED THAT THE PIPELINE DID BECOME STUCK IN THE PROXIMAL SIDE OF THE CATHETER PUSH WIRE DURING DELIVERY. THE PHYSICIAN DID NOT ATTEMPT TO R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389163 ↗
• MalfunctionFeb 2, 2026Retraction Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT NO RESISTANCE WAS FELT DURING DELIVERY OR POSITIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24233930 ↗
• MalfunctionJan 21, 2026Retraction Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 6MM AND A 5 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.  THE DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE LANDING ZONE WAS 4.3MM DISTALLY AND 4.5MM PROXIMALLY.   IT WAS REPORTED THAT WHEN A DEPLOYMENT OF THE PED PIPELINE 5.0X30 STENT WAS INITIATED IN THE DISTAL SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY. UPON REACHING ITS MIDDLE THIRD, A NON-EXPANSION POINT REMAINED. DEPLOYMENT CONTINUED, AND TENSION WAS RELEASED FROM THE SYSTEM MULTIPLE TIMES IN AN ATTEMPT TO OPEN THE SEGMENT, WITHOUT SUCCESS. THE DECISION WAS MADE TO RETRACT THE ENTIRE SYSTEM AND REPOSITION IT TO BEGIN A NEW DEPLOYMENT. IT WAS DEPLOYED WITHOUT COMPLICATIONS UP TO THE MIDDLE THIRD WITH ADEQUATE STENT EXPANSION, BUT THE NON-EXPANSION POINT IN THE MIDDLE THIRD PERSISTED. TENSION-RELEASE MANEUVERS WERE PERFORMED AGAIN WITHOUT SUCCESS. AS IT WAS NOT POSSIBLE TO REMOVE THE STENT FROM THE INSIDE OF THE PHENOM 27 MICROCATHETER, THE ENTIRE ASSEMBLY WAS SENT FOR ANALYSIS. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24138142 ↗
• MalfunctionDec 23, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT A PIPELINE EMBOLIZATION DEVICE WAS USED TO TREAT AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE INTERNAL CAROTID ARTERY. AFTER SUCCESSFUL DEPLOYMENT OF THE PIPELINE DEVICE, THE DEPLOYMENT WIRE BECAME STUCK ON THE PTFE SLEEVES DURING RETRACTION. THE DEPLOYMENT WIRE WAS SUBSEQUENTLY REMOVED TOGETHER WITH THE PHENOM 27 MICROCATHETER THROUGH THE DEPLOYED PIPELINE STENT. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, WITH A PLATELET REACTIVITY UNIT LEVEL OF 90. ANGIOGRAPHIC IMAGING POST PROCEDURE CONFIRMED SUCCESSFUL DEPLOYMENT OF THE PIPELINE FLEX. VESSEL TORTUOSITY WAS MINIMAL. NO PATIENT SYMPTOMS OR COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION RECEIVED REPORTED THAT IN RESPONSE TO THE EVENT, THE DOCTOR OFF LABEL "FLIPPED THE PTFE SLEAVES" OUTSIDE THE BODY PLACING THE DISTAL TIP OF THE PIPELINE DEVICE INTO A BOWL FILLED WITH SALINE, THEN PUSHED OUT THE RADIOPAQUE DISTAL WIRE EXPOSING THE PTFE SLEAVES AND PARTIALLY OPENING THE PIPELINE STENT UNDERWATER, THEN RETRACTING AND "FLIPPING" THE PTFE SLEAVE AND RETRACTING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23885716 ↗
• MalfunctionDec 9, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT PTFE SLEEVES WOULDN'T FLIP ON THE PIPELINE. THEY COULDN'T PULL PUSHER WIRE THROUGH THE PHENOM AND COULDN'T RECAPTURE THE PUSHER WIRE. THEY HAD TO PULL THE ENTIRE SYSTEM OUT TOGETHER. PUSHER WIRE/DELIVERY SYSTEM STUCK IN CATHETER. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23761043 ↗
• MalfunctionSep 8, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO SOLITAIRES WERE USED IN THE CASE AND REMOVED FROM PATIENT. A SECOND PULL WAS NEEDED SO THE SOLITAIRES WERE BACKLOADED ON THE FLUSHING SHEATHS BUT THEY WERE NOT ABLE TO LOAD THEM INTO THE MICRO CATHETERS. THEY HAD DIFFICULTY PUSHING THEM OUT OF THE FLUSHING SHEATHS AND AS A RESULT HAD TO PULL DIFFERENT SOLITAIRES. THE DIFFICULTY HAPPENED OUTSIDE THE BODY OF THE PATIENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF ISCHEMIC STROKE LOCATED IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA). IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22997127 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE, A PIPELINE FLEX EMBOLIZATION DEVICE WAS USED TO TREAT AN UNRUPTURED SACCULAR ANEURYSM IN THE INTERNAL CAROTID ARTERY. THE TIP OF THE PED2-500-14 DEVICE DID NOT FULLY EXPAND, AND A SUBSEQUENT ATTEMPT WITH THE PED2-500-16 DEVICE ALSO RESULTED IN INCOMPLETE TIP EXPANSION. THE PHYSICIAN ATTEMPTED BALLOON ANGIOPLASTY TO EXPAND THE DEVICE, BUT IT WAS UNSUCCESSFUL. AN ENTERPRISE STENT WAS ULTIMATELY DEPLOYED TO ASSIST IN FULLY OPENING THE PIPELINE, COMPLETING THE PROCEDURE. POST-PROCEDURE, THE PATIENT EXPERIENCED APHASIA AND AN INABILITY TO MOVE THEIR RIGHT HAND. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND ANGIOGRAPHIC RESULTS SHOWED THE FRONT END OF THE PED2-500-14 WAS NOT FULLY EXPANDED. THE PATIENT'S CONDITION IS GRADUALLY IMPROVING. ADDITIONAL INFORMATION RECEIVED REPORTED DURING THE PROCEDURE, THE PHYSICIAN USED A PIPELINE FLEX EMBOLIZATION DEVICE. HOWEVER, THE TIP OF THE PED2-500-14 DID NOT FULLY EXPAND. THERE WAS A VESSEL BEND SLIGHTLY BELOW THE POSITION WHERE THE PIPELINE WAS DEPLOYED. THE FIRST PED2-500-14 WAS USED TO ATTEMPT RESHEATHING. LATER, PED2-500-16 WAS USED TO ATTEMPT RESHEATHING, WIRE MASSAGE, A

  Patient problems: Dysphasia; Paralysis

  MAUDE report 22302890 ↗
• MalfunctionFeb 10, 2025Leak/Splash; Material Deformation; No Apparent Adverse Event; Leak/Splash; Material Deformation; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE PREPARATION FOR AN ANEURYSM COIL EMBOLIZATION, A CATHETER WAS BENT AND A LEAK WAS OBSERVED. THE LEAK LOCATION WAS UNKNOWN, AND THE CATHETER HAD NOT BEEN INSPECTED OR TESTED PRIOR TO USE. THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE. THE CATHETER WAS NOT IMPLANTABLE AND WAS REPLACED BY ANOTHER PRODUCT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344181 ↗
• MalfunctionFeb 6, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO FRICTION OR RESISTANCE DURING DELIVERY, POSITIONING, OR RETRIEVAL OF THE CATHETER OR AN INTRALUMINAL DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21321615 ↗
• MalfunctionFeb 5, 2025Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT DURING THE PREPARATION FOR AN ANEURYSM COIL EMBOLIZATION, A CATHETER WAS BENT AND A LEAK WAS OBSERVED. THE LEAK LOCATION WAS UNKNOWN, AND THE CATHETER HAD NOT BEEN INSPECTED OR TESTED PRIOR TO USE. THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE. THE CATHETER WAS NOT IMPLANTABLE AND WAS REPLACED BY ANOTHER PRODUCT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21314147 ↗
• MalfunctionJun 7, 2024Unintended Movement; Physical Resistance/Sticking; Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT TWO PED3 PIPELINE STENTS HAD SEVERE RESISTANCE IN THE PHENOM27 CATHETER. VANTAGE WAS BEING LOADED INTO PHENOM 27- THERE WAS A LOT OF RESISTANCE. VANTAGE WAS PREMATURELY DEPLOYED IN RHV DUE TO SO MUCH RESISTANCE. THAT DEVICE WAS PULLED OUT AND ANOTHER VANTAGE WAS OPENED. THE 2ND VANTAGE DEVICE STILL HAD A LOT OF RESISTANCE DURING DELIVERY, BUT HE WAS ABLE TO PUSH THROUGH AND GET IT TO THE M1. TIP COIL WAS FOLDED ON ITSELF, BUT DEVICE WAS DEPLOYED WITH NO ISSUES. THE RESISTANCE WAS IN THE PROXIMAL SECTION OF THE CATHETER. THE PUSHWIRE WAS NOT ROTATED OR PULLED BACK AT ANYTIME DURING THE PROCEDURE. THERE WAS CATHETER KICKBACK. THE PIPELINE DID NOT JUMP DURING DEPLOYMENT. 2 PIPELINES WERE USED TO OVERLAB IN INTERNAL CAROTID ARTERY. THE TIP OF THE CATHETER WAS NOT UNDERSTRESS. THE TIP OF THE CATHETER WAS NOT MOVED DURING DEPLOYMENT. THE CATHETER WAS FLUSHED AS PER INSTRUCTIONS FOR USE (IFU). THE DEVICES WERE PREPARED AS PER IFU. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE MAX DIAMETER WAS 5.4MM AND THE NECK DIAMETER WAS 6MM. THE DISTAL LANDING ZONE WAS 4.02MM AND THE PROXIMAL LANDI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19482038 ↗
• MalfunctionJun 22, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE BECAME STUCK AT THE HUB AND THE TIP COIL OF THE DEVICE FRACTURED OFF. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE PARA OPHTHALMIC WITH A MAX DIAMETER OF 4.75MM AND A 4MM NECK DIAMETER. THE LANDING ZONE WAS 4.35MM DISTALLY AND 4.50MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED AND PRU LEVEL WAS WITHIN ADEQUATE RANGES. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS TECHNICAL SUCCESS. THERE WAS SOME VASOSPASM AT THE END OF THE CASE THAT CLEARED AFTER WAITING A FEW MINUTES. IT WAS REPORTED THAT UTILIZING THE TRIAXIAL SYSTEM OF BMX81, ESPERANCE, AND PHENOM 27, THE DOCTOR SUCCESSFULLY DEPLOYED PED2-450-14 IN THE LEFT ICA AND WANTED TO PLACE ANOTHER DEVICE ACROSS THE NECK OF THE ANEURYSM. WHILE LOADING PED2-450-12 INTO THE PHENOM 27, THE PHYSICIAN FELT RESISTANCE AS HE ADVANCED THE DEVICE THROUGH THE PHENOM 27 CATHETER. THE DECISION WAS MADE TO ATTEMPT TO RESHEATH THE DEVICE OUT OF THE PHENOM 27, HOWEVER THE STENT DEPLOYED INTO THE HUB OF THE PHENOM 27 CATHETER. THE DOCTOR WAS ABLE TO REMOVE THE STENT FROM THE HUB UTILIZING

  Patient problems: Vasoconstriction

  MAUDE report 17186940 ↗
• MalfunctionApr 6, 2022Leak/Splash; Physical Resistance/Sticking; Leak/Splash; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT TWO SFR4 SOLITAIRE STENTS WOULD NOT FIT THROUGH TWO PHENOM AND OTHER CATHETERS. ONE PHENOM CATHETER APPEARS A WIRE OR SOMETHING WAS STICKING OUT. THE PATIENT WAS BEING TREATED FOR AN ISCHEMIC STROKE IN THE POSTERIOR CEREBRAL ARTERY (PCA). MRS BASELINE WAS 2. SEVERAL PASSES WAS MADE WITH THE DEVICE. VESSEL TORTUOSITY WAS MODERATE. THE TREATMENT WAS A MECHANICAL THROMBECTOMY. ACCESS VESSEL WAS THE FEMORAL WITH A DIAMETER OF 4MM. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).  SOLITAIRE 6 X 40 (PLI40) WAS INITIALLY OPENED. THEY TRIED TO PUT IT THROUGH A VELOCITY PENUMBRA .025 INCH MICRO CATHETER. THE SOLITAIRE WOULD NOT PUSH THROUGH. THEY EXCHANGE FOR A DIFFERENT PENUMBRA VELOCITY MICRO CATHETER. THE SOLITAIRE DID NOT FIT THROUGH. THEY CHANGED AND WENT TO ATHENA AND 27 CATHETER THE SOLITAIRE WOULD NOT FIT THROUGH. THEY CHANGED TO A DIFFERENT SOLITAIRE. THE ONE LISTED ON THIS REPORT 6X40 (PLI10) IT WOULD NOT GO THROUGH. IN EACH CASE IT WAS STUCK IN THE PROXIMAL PART OF THE MICROCATHETERS. THEY TRIED A .021 INCH PHENOM WHICH IS LISTED HERE IN THIS REPORT AND THE SOLITAIRE WOULD NOT GO THROUGH. THEY EVENTUALLY WENT BACK TO THE O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14030837 ↗
• MalfunctionJan 7, 2022Compatibility Problem; Physical Resistance/Sticking; Compatibility Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THEY COULD NOT PASS THE SOLITAIRE THROUGH THE CATHETER AS THERE WAS CATHETER OCCLUSION. THE PATIENT WAS UNDERGOING SURGERY FOR STROKE MT TREATMENT. THE PATIENT'S BLOOD FLOW WAS NOT INDICATED AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THEY COULD NOT PASS THE SOLITAIRE THROUGH THE CATHETER AS THERE WAS CATHETER OCCLUSION. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PRODUCT WAS REPLACED WITH A NON-MEDTRONIC PRODUCT.  ANCILLARY DEVICES INCLUDE A 8F TERUMO GUIDEWIRE, A SYNCHRO 2, AND A WALRUS BGC RED 72 SOLITAIRE 6X40.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13191673 ↗