Phenom™ Catheter FG15150-0615-1SV02Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00814584028981), received between Nov 15, 2018 and Oct 14, 2020 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2020Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT THE PHENOM CATHETER¿S PROXIMAL END BROKE DURING THE PROCEDURE. DURING A PIPELINE FLEX WITH SHIELD EMBOLIZATION, THE PIPELINE WAS DEPLOYED AT TERMINAL ICA. RESISTANCE IN PUSHER WIRE NOTED AT PROXIMAL DEPLOYMENT. INCREASING TENSIONON PHENOM CATHETER REQUIRED TO BALANCE FORCE ON DELIVERY WIRE. PHENOM CATHETER HUB SNAPPED OFF AT JUNCTION WITH THE BLUE PART OF THE CATHETER. FORCE WAS APPLIED DURING DELIVERY AND REMOVAL. THE CATHETER WAS NOT TRAPPED AND THERE WAS NO VASOSPASM. THE CATHETER WAS NOT STUCK IN THE GUIDE CATHETER. THE CATHETER AND THE SEPARATED PIECE WILL BE RETURNED FOR ANALYSIS. NO PATIENT INJURY REPORTED. THE ANATOMY WAS MODERATE IN TORTUOSITY. IT WAS REPORTED THAT PIPELINE DEVICE WAS IMPLANTED AT INTENDED LOCATION. YES, THE CONTINUOUS FLUSH ADMINISTERED DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10677101 ↗
• MalfunctionMar 9, 2020Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT ONE PIPELINE FAILED TO DEPLOY AND TWO DELIVERY SYSTEMS BECAME STUCK UPON REMOVAL. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A LEFT, SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 5MM AND A 8MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE FIRST PIPELINE (PLI40) WAS DELIVERED TO THE DISTAL ICA TERMINUS. THE WIRE WAS RETRIEVED, AND UPON PULLING OUT THE WIRE, IT BECAME STUCK IN THE MIDDLE SEGMENT OF THE PHENOM 27 MICROCATHETER. EVERYTHING WAS REMOVED, A SECOND PHENOM 27 WAS DELIVERED FOLLOWED BY A SECOND PIPELINE (PLI30). THE PIPELINE BECAME TWISTED AND WOULD NOT STRAIGHTEN OUT OR OPEN AFTER NUMEROUS RE-SHEATHING AND RE-DEPLOYMENT ATTEMPTS. UPON REMOVAL, THE PIPELINE BECAME STUCK ABOUT HALFWAY, AND THE ENTIRE SYSTEM WAS REMOVED. A THIRD PHENOM 27 WAS USED AND SUCCESSFULLY DELIVERED THE SECOND PIPELINE INTO THE PATIENT SUCCESSFULLY TO COMPLETE THE PROCEDURE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE A NEURON MAX AND NAVIEN 58.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9804179 ↗
• InjuryDec 13, 2019Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT OF A PERFORATION DURING A PROCEDURE. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN ANEURYSM. VESSEL TORTUOSITY WAS DESCRIBED AS NORMAL. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHENOM FELT VERY STIFF AND AS A RESULT, THE WIRE WAS NAVIGATED FURTHER DISTALLY, WHICH CAUSED PERFORATION. THE PERFORATION WAS TREATED BY SACRIFICING THE VESSEL WITH COILS. POST-PROCEDURE, THE PATIENT WAS HEMIPLEGIC AND COULD NOT SIT UP LONGER THAN 15 SECONDS.

  Patient problems: Perforation

  MAUDE report 9470358 ↗
• MalfunctionSep 18, 2019Break; Break

  MEDTRONIC RECEIVED A REPORT THAT A PHENOM CATHETER FRACTURED DURING A PROCEDURE. THE PATIENT WAS UNDERGOING TREATMENT OF AN M1 STROKE CASE. THE ANATOMY WAS SEVERE IN TORTUOSITY. IT IS UNKNOWN IF THE DEVICE WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE. THE PHENOM CATHETER CAME OUT OF THE PACKAGE IN A GOOD CONDITION. THE PHENOM, AFTER THE PASS OF THE THROMBECTOMY DEVICE, HAD DIFFICULTY EXITING THE PATIENT. CONSIDERABLE FORCE WAS USED TO PULL OUT THE CATHETER CAUSING IT TO BREAK. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9084585 ↗
• MalfunctionSep 18, 2019Break; Break

  MEDTRONIC RECEIVED A REPORT THAT A PHENOM CATHETES FRACTURED DURING A PROCEDURE. THE PATIENT WAS UNDERGOING TREATMENT OF AN M1 STROKE CASE. THE ANATOMY WAS SEVERE IN TORTUOSITY. IT IS UNKNOWN IF THE DEVICE WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE. THE PHENOM CATHETER CAME OUT OF THE PACKAGE IN A GOOD CONDITION. PHENOM ADVANCEMENT IN THE PATIENT WAS REPORTEDLY FINE. ON RETRIEVAL, IT WAS REPORTED THAT EXCESSIVE FORCE WAS REQUIRED TO REMOVE THE CATHETER FROM PATIENT ANATOMY AND THE CATHETER REPORTEDLY BROKE. PER THE USER, THE SEVERE TORTUOSITY COMING OUT OF THE ICA ARCH PUT TOO MUCH STRAIN ON BOTH CATHETER AND THROMBECTOMY DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9084583 ↗
• MalfunctionAug 8, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT PIPELINE FLEX EMBOLIZATION DEVICE FELT RESISTANCE IN THE PHENOM CATHETER AND PIPELINE PIERCED/PUNCTURED THE HUB AND IS PARTIALLY DEPLOYED OUTSIDE OF THE MICROCATHETER INNER LUMEN. THE PHENOM CATHETER BROKE AT THE PROXIMAL PART. IT WAS CONFIRMED THAT THE PHENOM CATHETER BROKE NEAR THE HUB AND THE PIPELINE CAME OUT FROM THE BROKEN LOCATION. THE ISSUE WAS CAUSED BY RESISTANCE FROM THE CATHETER. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR AN UNRUPTURED SACCULAR ANEURYSM LOCATED IN RIGHT INTERNAL CAROTID ARTERY. IT WAS REPORTED THAT UPON DELIVERY OF THE PED INTO THE PHENOM MICROCATHETER THE IMPLANTER FELT MILD RESISTANCE, NOTHING THAT HASN'T BEEN FELT IN PREVIOUS CASES. HE CONTINUED TO PUSH WHEN HE REALIZED THAT THE PED HAD PIERCED THE PHENOM AND WAS BEING DEPLOYED OUTSIDE OF THE INNER LUMEN OF THE MC. HE THEN REMOVED THE ENTIRE MC AND PED DELIVERY SYSTEM AND SET ASIDE FOR RETURN TO MEDTRONIC. A NEW PED (425-16) CHOSEN ALONG WITH A NEW PHENOM27 AND CASE RESUMED WITHOUT INCIDENT. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. YES, DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. NO IMAGES AVAILABLE FOR REVIEW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8875035 ↗
• InjuryAug 5, 2019Break; Break

  MEDTRONIC RECEIVED INFORMATION THROUGH MEDWATCH THAT TIP OF THE CATHETER BROKE. THE TIP WAS ABLE TO RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8860950 ↗
• InjuryJul 5, 2019Material Perforation; Material Perforation

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE WAS PLACED PERFECTLY DURING THE FIRST PASS, BUT IT WAS A BIT DISTAL AND THE STENOSIS COULDN'T BE COVERED WITH IT. DURING RESHEATHING OF THE PIPELINE DUE TO THIS ISSUE, THE MICROCATHETER AND PIPELINE PUSHED A BIT HARD INTO THE ARTERY WALL. THEN, DURING SECOND DEPLOYMENT OF THE PIPELINE THE PHYSICIAN NOTED THAT THE DEVICE TWISTED, SO THEY TOOK THE WHOLE SYSTEM OUT OF THE PATIENT. CONTRAST INJECTION PERFORMED SHOWED A PERFORATED ICA, SO THEY COILED THE ICA WITH COILS 1 PLUG, AND GLUE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR CAVERNOUS SEGMENT OF THE LEFT ICA WITH A MAX DIAMETER OF 4.3MM. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED WHICH SHOWED A PRU LEVEL OF 98%. POST PROCEDURE ANGIOGRAPHIC RESULTS SHOWED AN OPEN ACOM, LEFT ICA CLOSED WITH PLUG, COILS, AND GLUE. DISTALLY OF THE LEFT MEDIA WAS THE SMALL ISCHEMIC STROKE, DELAY OF 1.6S REGARDING RIGHT MEDIA. ANCILLARY DEVICES INCLUDE A 6FR DESTINATION LONG SHEATH 90CM SHEATH, 6F BENCHMARK 071MP - LOT F89067 GUIDE CATHETER, SYNCHRO 0.014" GUIDEWIRE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 8765047 ↗
• InjuryMar 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE FLEX WITH SHIELD DID NOT OPEN IN THE MIDDLE AND PROXIMAL SECTIONS. DURING ATTEMPT TO OPEN THE DEVICE, A CAROTID CAVERNOUS FISTULA (CCF) WAS NOTED TO HAVE DEVELOPED. THE PED2¿S MIDDLE SECTION WAS PLACED IN A BEND. MORE THAN 50% OF THE DEVICE WAS DEPLOYED WHEN THE EVENT OCCURRED. THE DEVICE WAS SHEATHED LESS THAN OR EQUAL TO 2 TIMES. NO ADDITIONAL STEPS WERE MADE TO OPEN THE DEVICE. THE DEVICE WAS NOT REMOVED AND WAS IMPLANTED IN THE PATIENT. FULL WALL APPOSITION WAS NOT ACHIEVED. A BALLOON WAS NOT USED TO ATTEMPT IN OPENING THE DEVICE. THE PED2 WAS DEPLOYED IN INTERNAL CAROTID ARTERY (ICA) AND OPENING WELL DISTALLY IN COMMUNICATING SEGMENT AND ACROSS ANEURYSM NECK. HOWEVER, IT WAS NOT FLARING AROUND CLINKED BEND AND INTO CAVERNOUS SEGMENT. RESHEATHED AND REDEPLOYED SLIGHTLY MORE DISTALLY; IMPROVED OPENING BUT STILL NOT NORMAL. RESHEATHED A SECOND TIME AND REDEPLOYED AGAIN WITH STAGED ADJUSTMENT OF CATHETER TENSION/ BRAID DELIVERY- SAME APPEARANCE OF NON-OPENING PROXIMALLY. WITH MANIPULATION THE PHENOM TIP HAD WAS BETWEEN DEPLOYMENT AND RESHEATHING MARKER. ATTEMPTED TO RECAPTURE THE BRAID A FINAL TIME AND THE PED DEPLOYED. IT OPENED PROXIMA

  Patient problems: Fistula

  MAUDE report 8424701 ↗
• InjuryNov 15, 2018Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT DURING A STROKE CASE, THE PHENOM MICROCATHETER'S DISTAL MARKER SEPARATED IN THE ANATOMY DURING PROCEDURE. IT WAS REPORTED THAT MEDTRONIC BALLOON GUIDECATHETER AND THE PHENOM ADVANCED INTO THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE PHENOM WAS UNABLE TO BE ADVANCE PASS THE MCA, THEREFORE, THE DEVICES WERE RETRIEVED. RESISTANCE WAS FELT AND A FOLLOW UP ANGIO WAS TAKEN. IT WAS NOTED THAT THE PHENOM DISTAL MARKER WAS IN THE RIGHT MCA/ M1. UPON COMPLETING THE INTERVENTION, THE MARKER WAS NOTED TO HAVE TRAVELED TO THE TEMPORAL M1 AREA. THE ANATOMY WAS REPORTED TO HAVE SEVERE TORTUOSITY. THE PATIENT DID NOT HAVE A NEUROLOGICAL DECLINE ASSOCIATED WITH THE DETACHED MARKER. THERE IS NOT ANY PLAN TO REMOVE THE DETACHED PHENOM .027 MARKER FROM THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8074145 ↗