Phenom™ Catheter FG15150-0630-1SV02Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00814584029001), received between Mar 22, 2019 and Nov 1, 2019 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF CAROTID CAVERNOUS FISTULA DURING A PROCEDURE. THE PATIENT WAS UNDERGOING TREATMENT OF AN UNRUPTURED ANEURYSM IN THE INTERNAL CAROTID ARTERY (ICA.) ANATOMY WAS REPORTEDLY VERY TORTUOUS. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). IT WAS REPORTED THAT DURING THE PROCEDURE, A PIPELINE FLEX WAS ATTEMPTED TO BE PLACED. DURING ADVANCEMENT OF THE PIPELINE FLEX, A LARGE AMOUNT OF FORCE WAS REQUIRED THROUGH THE DISTAL SECTION OF THE PHENOM CATHETER. THE PROCEDURE WAS ABANDONED AND A CAROTID CAVERNOUS FISTULA (CCF) WAS NOTED. THE CCF WAS COILED. THE PATIENT DID NOT EXPERIENCE A NEUROLOGICAL DECLINE FROM BASELINE.

  Patient problems: Fistula

  MAUDE report 9268995 ↗
• MalfunctionJul 2, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT RESISTANCE WAS FELT WHEN PUSHING PAST THE FIRST BEND IN THE ICA, RESULTING IN THE PIPELINE BECOMING STUCK. AS A RESULT THE PHENOM AND PIPELINE WERE REMOVED TOGETHER, DURING WHICH IT WAS DISCOVERED THAT THE CATHETER HAD SPLIT/SEPARATED IN THE DISTAL END. THE DEVICES WERE REPLACED AND THE PROCEDURE COMPLETED WITHOUT FURTHER ISSUE. THE PATIENT WAS UNDERGOING SURGERY FOR AN UNRUPTURED, SACCULAR LEFT ICA ANEURYSM WITH A NECK DIAMETER OF 4.2MM. IT WAS NOTED THAT THE VESSEL TORTUOSITY WAS MINIMAL. THE DEVICES WERE PREPARED PER THE IFU. THERE WAS NO FRICTION DURING DELIVERY, NO FORCE WAS APPLIED, THE CATHETER TIP WAS NOT STUCK. ANCILLARY DEVICES INCLUDE A NEURON MAX SHEATH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8753932 ↗
• MalfunctionJun 11, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT ONE PHENOM CATHETER BROKE. SECOND PIPELINE STUCK WITHIN THE PHENOM 027 CATHETER. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR A MEDIUM UNRUPTURED AMORPHOUS INTERNAL CAROTID ARTERY ANEURYSM, MEASURING 15MM, LANDING ZONE DISTAL 4.2MM, PROXIMAL 4.25MM. THE VESSEL WAS OBSERVED SEVERELY TORTUOUS. IT WAS REPORTED THAT FIRST PIPELINE FLEX (LOT NUMBER A324633) ADVANCED INTO PHENOM CATHETER (LOT NUMBER 0C18-062). PHENOM CATHETER BROKE DISTALLY. PIPELINE FLEX AND PHENOM WERE THEN REMOVED AS A UNIT FROM THE PATIENT. THERE WAS NOT ANY FRICTION OR DIFFICULTY DURING DELIVERY. YES, THERE FORCE APPLIED DURING DELIVERY OR REMOVAL. THERE WAS NOT ANY VASOSPASM. THE CATHETER WAS FLUSH WITH HEPARINIZED SALINE. (10, 30) IT WAS REPORTED THAT SECOND PIPELINE FLEX ADVANCED INTO PHENOM 027. ATTEMPTED TO UN-SHEATH THE PIPELINE FLEX TIP COIL. PIPELINE FLEX APPEARED TO BE STUCK WITHIN THE PHENOM 027. PIPELINE FLEX TIP COIL COULD NOT BE UN-SHEATHED, NOR COULD THE PIPELINE FLEX BE FURTHER ADVANCED FROM THE PHENOM 027. BOTH PHENOM 027 AND PIPELINE FLEX (LOT NUMBER A415966) WERE REMOVED AS A UNIT. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. THE CATHETER WA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8688325 ↗
• InjuryMay 28, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT M5 VESSEL WAS PERFORATED AND EXTRAVASATION OCCURRED. THIS EVENT WAS REPORTED TO HAVE OCCURRED DURING PUSHING OF THE DELIVERY WIRE TO ADVANCE PIPELINE IN PHENOM MICROCATHETER. THE VESSEL WAS EXTREMELY TORTUOUS, AND IT WAS DIFFICULT TO ADVANCE. SYSTEM THEN SUDDENLY MOVED FORWARD AND CAUSED PERFORATION OF M5 VESSEL. OTHER DETAILS WILL NOT BE PROVIDED DUE TO CONFIDENTIALITY REASONS. THERE WAS ALSO REPORT OF DEVICE LOCKED UP WITHIN THE CATHETER. HOWEVER, THE PIPELINE WAS NOT STUCK. THE CATHETER WAS REPORTED TO HAVE BEEN DAMAGED (UNKNOWN LOCATION). THE PIPELINE AND THE ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. THE PATIENT WAS ON DUAL ANTIPLATELET TREATMENT (DAPT). THE PATIENT WAS BEING TREATED FOR RIGHT AN OPHTHALMIC INTERNAL CAROTID ARTERY (ICA). THE ANEURYSM WAS UNRUPTURED AND SACCULAR.

  Patient problems: Intracranial Hemorrhage; Neurological Deficit/Dysfunction; Perforation

  MAUDE report 8646590 ↗
• MalfunctionMar 24, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF PHENOM CATHETER FRACTURE DURING A PROCEDURE. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT FOR A SMALL RUPTURED SACCULAR LEFT OPHTHALMIC ANEURYSM, MEASURING 8MM X 4MM, LANDING ZONE DISTAL 3.4MM, PROXIMAL 3.9. THE VESSEL WAS MINIMAL TORTUOUS. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. IT WAS REPORTED THAT THE FLOW DIVERSION DEVICE WAS DIFFICULT TO ADVANCE WHEN APPROACHING THE DISTAL END OF PHENOM CATHETER. THE PHYSICIAN COMPLAINED THAT IT WAS FAR MORE DIFFICULT THAN NORMAL. THE PHYSICIAN ATTEMPTED ONCE MORE, HEARD A ¿POP¿ AND PUSHER WIRE THEN KINKED. REMOVED THE SYSTEM AND FLOW DIVERSION DEVICE APPEARED TO BE LOCKED INSIDE THE PHENOM CATHETER. THE POP APPEARED TO BE THE PHENOM FRACTURING. ANOTHER DEVICE WAS USED SUCCESSFULLY, AND PROCEDURE COMPLETED. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8446846 ↗
• MalfunctionMar 22, 2019Break; Break

  MEDTRONIC RECEIVED A REPORT OF PHENOM SEPARATION. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT FOR A MEDIUM UNRUPTURED AMORPHOUS INTERNAL CAROTID ARTERY ANEURYSM, MEASURING 15MM, LANDING ZONE DISTAL 4.2MM, PROXIMAL 4.25MM. THE VESSEL WAS OBSERVED SEVERELY TORTUOUS. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. A CONTINUOUS HEPARINIZED SALINE FLUSH WAS MAINTAINED DURING THE PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, A FLOW DIVERSION DEVICE WAS ADVANCED INTO PHENOM CATHETER. PHENOM CATHETER BROKE DISTALLY. THE FLOW DIVERSION DEVICE AND PHENOM WERE THEN REMOVED AS A UNIT FROM THE PATIENT. THERE HAD REPORTEDLY BEEN NO FRICTION/DIFFICULTY DURING DELIVERY. FORCE HAD BEEN APPLIED. THERE WAS NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8445935 ↗