BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EUPHORA RX

    MDR report key: 23541716 · Received November 13, 2025

    Report

    Report Number
    9617601-2025-02695
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    November 11, 2025
    Report Date
    December 15, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    LOX
    UDI-DI
    00643169560147
    PMA / PMN Number
    K143480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE DEVICE WAS BEING USED TO PRE-DILATE THE LESION. THE DEVICE DETACHED/SEPARATED INTO TWO PIECES. THE DETACHED PORTION WAS HANGING OUT OF THE GUIDE WHEN IT BROKE. RESISTANCE WAS NOTED DURING WITHDRAWAL OF THE DEVICE AND EXCESSIVE FORCE WAS USED. LOT NUMBER UPDATED. PRODUCT ANALYSIS: THE DEVICE RETURNED FOR EVALUATION WITH A DETACHMENT ON THE HYPOTUBE. KINKS WERE EVIDENT ON THE HYPOTUBE DISTAL TO THE DETACHMENT SITE. THE DETACHMENT SITE ON THE HYPOTUBE WAS APPROXIMATELY 20 CM FROM STRAIN RELIEF. THE HYPOTUBE MATERIAL AT THE DETACHMENT SITE WAS OVAL AND JAGGED. NO OTHER DAMAGE EVIDENT TO THE REMAINDER OF THE DEVICE. 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

    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

    IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE EUPHORA CORONARY BALLOON CATHETER, THE DEVICE DETACHED, CRACKED OR FRACTURED. THE DEVICE WAS PUSHED AND TWISTED IN ORDER TO ADVANCE IT AND NEVER CROSSED THE LESION. THE DEVICE COMPLETELY BROKE AS IT WAS BEING PULLED OUT OF THE PATIENT. THE BREAK OCCURRED AT THE CATHETER. THE DETACHED PORTION WAS EXPOSED AT THE SHEATH AND WAS ABLE TO  BE REMOVED FROM THE BODY.  THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS MODERATELY TORTUOUS AND SEVERELY CALCIFIED LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 99% STENOSIS. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE.  EXCESSIVE FORCE WAS USED DURING DELIVERY.  THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2248760 EUPHORA RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, LOX MEDTRONIC MEXICO S. DE R.L. DE CV EUP3012X 230722434 00643169560147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male