BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHENOM CATHETER

    MDR report key: 25021997 · Received April 28, 2026

    Report

    Report Number
    9617601-2026-02807
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    April 7, 2026
    Report Date
    April 28, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    QJP
    UDI-DI
    00763000399702
    PMA / PMN Number
    K151638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT PRODUCT ID PED2-375-12 (LOT D001781);  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 AFTER DELIVERY, THE PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT PUSHWIRE/CAPTURE COIL WAS STUCK AT THE SLEEVES DURING RETRACTION INTO THE PHENOM 27 MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, ANTERIOR CHOROIDAL ARTERY ANEURYSM. THE LANDING ZONE ARTERIAL DIAMETER WAS 3.5 MM DISTALLY AND 3.7 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE REPORTED VERY GOOD DISTAL AND PROXIMAL LANDING ZONES AND WALL APPOSITION. AFTER THE PIPELINE WAS DEPLOYED, AN ATTEMPT WAS MADE TO RECAPTURE THE WIRE WITH THE PHENOM 27 BUT THE WIRE WAS UNABLE TO BE PULLED INTO THE MICROCATHETER BECAUSE OF THE SLEEVES. THE MICROCATHETER AND WIRE WERE REMOVED TOGETHER WITH THE TIP COIL REMAINING OUTSIDE OF THE CATHETER. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IT WAS REPORTED THAT THE PIPELINE WAS USED FOR AN APPROVED INDICATION (ON-LABEL). THE PUSHWIRE WAS NOT ROTATED DURING REMOVAL. THE PUSHWIRE / CAPTURE COIL WAS STUCK AT THE SLEEVES PROXIMAL TO THE TIP COIL. THERE WAS NO DAMAGE TO THE CATHETER OR PUSHWIRE. THE CAPTURE COIL WAS NOT DAMAGED DURING REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52692 PHENOM CATHETER CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MEDTRONIC MEXICO S. DE R.L. DE CV FG15150-0615-1S 233094973 00763000399702

    Patients

    Seq Age Sex Outcome Treatment
    1