BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHENOM CATHETER

    MDR report key: 24683388 · Received March 25, 2026

    Report

    Report Number
    9617601-2026-02000
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    January 6, 2026
    Report Date
    April 8, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    QJP
    UDI-DI
    00763000399702
    PMA / PMN Number
    K151638
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H3 PRODUCT ANALYSIS: DRAWING(S) REFERENCED: DWGSFG15XXX-YYYY-ZZ REV. F, DWGS50636 REV. A AS FOUND CONDITION: THE PUSHWIRE WAS RETURNED STUCK AT THE DISTAL TIP OF THE PHENOM 27 CATHETER, INSIDE A BIO-HAZARD BAG, AND A SHIPPING BOX. THE TIP COIL AND THE SLEEVES APPEARED TO BE DEPLOYED OUTSIDE THE CATHETER TIP. THE PIPELINE FLEX SHIELD BRAID WAS NOT RETURNED. DAMAGE LOCATION DETAILS: THE DISTAL AND PROXIMAL DPS RESTRAINTS WERE INTACT. THE DPS SLEEVES SHOWED NO SIGNS OF DAMAGE AND WERE FOUND TO BE INTACT. THE DISTAL HYPOTUBE AND PTFE SHRINK TUBING WERE ALSO INTACT, EXHIBITING NO SIGNS OF ELONGATION. NO DEFECTS WERE FOUND IN THE TIP COIL, DISTAL MARKER, RE-SHEATHING MARKER, RESHEATHING PAD, OR PROXIMAL BUMPER. THE CATHETER TIP AND MARKER APPEARED TO BE FLATTENED. THE CATHETER BODY WAS FOUND TO BE ACCORDIONED BETWEEN 7.0 CM AND 10.7 CM FROM THE DISTAL TIP. NO OTHER ANOMALIES WERE NOTED. TESTING/ANALYSIS: THE PUSHWIRE WAS DIFFICULT TO PUSH OUT FROM THE CATHETER LUMEN. THE SLEEVES WERE MEASURED ~3.0MM, WHICH IS WITHIN SPECIFICATIONS. THE TOTAL AND USABLE LENGTHS WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. THE CATHETER WAS FLUSHED WITH WATER AND WAS FOUND TO BE PATENT. AN IN-HOUSE 0.026¿ MANDREL WAS THEN TESTED BY RUNNING IT THROUGH THE CATHETER HUB, SUCCESSFULLY PASSING THROUGH WITHOUT ISSUES. HOWEVER, RESISTANCE WAS OBSERVED AT THE DAMAGED LOCATIONS. CONCLUSION: BASED ON THE RETURNED DEVICES, THE CUSTOMER REPORT OF "DELIVERY SYSTEM STUCK DURING RETRACTION" THE DAMAGED CATHETER TIP LIKELY PREVENTED THE PUSHWIRE FROM RETRACTING BACK INTO THE CATHETER LUMEN. THE OBSERVED DAMAGE TO THE CATHETER (FLATTENING/ACCORDIONING) AND HYPOTUBE (STRETCHING), SUGGESTS THAT HIGH FORCE WAS PROBABLY APPLIED. THIS DAMAGE MAY HAVE OCCURRED WHEN THE CUSTOMER ATTEMPTED TO ADVANCE OR RETRIEVE THE PIPELINE FLEX SHIELD THROUGH THE CATHETER AGAINST RESISTANCE. POSSIBLE CAUSES OF THE RESISTANCE INCLUDE VESSEL TORTUOSITY AND THE LACK OF A CONTINUOUS FLUSH WITH HEPARINIZED SALINE DURING DELIVERY. HOWEVER, THE CUSTOMER INDICATED THAT THE VESSEL TORTUOSITY WAS NORMAL AND A CONTINUOUS FLUSH WAS USED, WHICH RULES THEM OUT AS POTENTIAL CAUSES. THE ROOT CAUSE COULD NOT BE DETERMINED. THE CUSTOMER REPORT OF "PED STUCK ON DPS" WAS NOT CONFIRMED, AS THE BRAID WAS NOT RETURNED. THE LENGTH OF THE SLEEVES WERE MEASURED WITHIN SPECIFICATIONS. THE ROOT CAUSE COULD NOT BE DETERMINED. POSSIBLE CAUSES INCLUDE DAMAGED BRAID OR DAMAGED SLEEVES. HOWEVER, NO DAMAGE WAS FOUND WITH THE SLEEVES, WHICH RULES IT OUT AS A POTENTIAL CAUSE. SINCE THE BRAID WAS NOT R ETURNED, ANY CONTRIBUTION IT MADE TO THE REPORTED ISSUE COULD NOT BE ASSESSED, AND IT COULD NOT BE RULED OUT AS A POSSIBLE CAUSE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT THAT THE FINS OF THE PIPELINE DELIVERY SYSTEM, AFTER BEING RELEASED, WERE UNABLE TO ENTER THE MICROCATHETER, MAKING IT IMPOSSIBLE TO USE THE MICROCATHETER, WHICH WAS STUCK IN THE PHENOM 27 MICROCATHETER. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR A CEREBRAL ANEURYSM LOCATED IN THE LEFT INTERNAL CAROTID ARTERY. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION RECEIVED. THE ANEURYSM LOCATED IN THE OPHTHALMIC SEGMENT OF THE INTERNAL CAROTID ARTERY. THE PIPELINE DEVICES INVOLVED WERE PED2-400-20 (LOT: D013498) AND PED2-400-18 (LOT: D049284). THE PROBLEM OCCURRED WHEN THE PIPELINE SYSTEM COULD NOT BE ADVANCED INSIDE THE PHENOM 27 MICROCATHETER, DESPITE ALL INSTRUCTIONS FOR USE BEING FOLLOWED CORRECTLY. THIS ISSUE SPECIFICALLY INVOLVED THE MICROCATHETER, AS THE PIPELINE FLAPS BECAME STUCK AND COULD NOT BE ADVANCED. THERE WERE NO PROBLEMS OR OBSERVED BENDING OR DAMAGE TO THE PHENOM 27, PHENOM PLUS CATHETERS, OR THE PIPELINE DEVICES. THE CAUSE OF THE EVENT WAS NOT DETERMINED. THROUGHOUT THE PROCEDURE, A CONTINUOUS FLUSH OF SALINE SOLUTION WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CLARIFIED THAT THE PROBLEM OCCURRED AS SOON AS THE PIPELINE DEVICE ENTERED THE PHENOM 27 MICROCATHETER DURING DELIVERY, THE PHYSICIAN IMMEDIATELY FELT RESISTANCE DESPITE CONFIRMING THAT THE PHENOM 27 MICROCATHETER WAS SIZE COMPATIBLE WITH THE PIPELINE SHIELD DEVICE. AFTER IMPLANTATION OF THE PED2-400-20, THE PHYSICIAN ATTEMPTED TO PULL ONLY THE DELIVERY SYSTEM BACK INTO THE DISTAL END OF THE PHENOM 27 MICROCATHETER, BUT THE FINS BECAME STUCK AND WERE UNABLE TO FULLY ENTER THE DISTAL PORTION OF THE PHENOM 27 MICROCATHETER. SO, THE DOCTOR HAD TO REMOVE THE ENTIRE SYSTEM, AND THEY USED NEW MICROCATHETER WITH A NEW PIPELINE TO COMPLETE THE ANEURYSM CLOSURE TREATMENT. THE PROCEDURE WAS COMPLETED BY REPLACING THE ENTIRE SYSTEM, MICROCATHETER, MICRO GUIDE, AND THEN INSERTING THE PIPELINE. THE TWO PEDS WERE SUCCESSFULLY DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469483 PHENOM CATHETER CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MEDTRONIC MEXICO S. DE R.L. DE CV FG15150-0615-1S 232091845 00763000399702

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female