BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAUNCHER 6F GUIDE CATHETER

    MDR report key: 22645053 · Received July 29, 2025

    Report

    Report Number
    1220452-2025-00017
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    June 14, 2025
    Report Date
    August 25, 2025
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DQY
    PMA / PMN Number
    K021256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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

    ADDITIONAL INFORMATION: THE STENT WAS NOT ABLE TO CROSS THE LESION TO DEPLOY AND WAS ALSO NOT ABLE TO BE PULLED BACK THROUGH THE NON MEDTRONIC GEC. THE STENT HAD TO BE DEPLOYED WHERE IT WAS. THE STENT WAS OBSERVED TO BE HANGING IN THE AORTA AND NEEDED TO BE PUSHED INTO THE LM. IT WAS DIFFICULT TO POSITION AND ADVANCE THE STENT INTO THE CORRECT VESSEL. THERE WAS NO DIFFICULTY REMOVING THE LAUNCHER GUIDE CATHETER FROM THE GUIDEWIRE OR THE PATIENT. THE NON MEDTRONIC WIRE DID NOT GET STUCK IN THE STENT. CORRECTION: THE GUIDE CATHETER USED WAS A 6F LAUNCHER GUIDE CATHETER. THE NON-MEDTRONIC GUIDEWIRE WAS A 0.014X190CM 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT FAILED TO CROSS THE LESION. THE LESION BEING TREATED WAS NON-TORTUOUS, MILDLY CALCIFIED AND LOCATED IN THE OSTIUM LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH A EUPHORA BALLOON WITH NO ISSUES NOTED, BUT THE VESSEL/LESION WAS NOT PREPPED FOR CALCIUM PRIOR TO STENTING. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DEVICE DELIVERY. IT WAS DETAILED THAT THE STENT BECAME STUCK ON THE STEPDOWN OF THE NON-MEDTRONIC GUIDE EXTENSION CATHETER (GEC) AND GUIDE. THE NON-MEDTRONIC 0.14X190CM GUIDEWIRE WAS TRAPPED IN THE STENT STRUT WHEN THE STENT WAS DEPLOYED. THERE WAS THEN DIFFICULTY REMOVING THE NON-MEDTRONIC GEC, GUIDEWIRE, AND THE MEDTRONIC GUIDE CATHETER. AFTER REMOVAL OF THE NON-MEDTRONIC GEC AND GUIDEWIRE, THE STENT WAS OBSERVED TO BE HANGING IN THE AORTA. THE STENT WAS THEN CRUSHED INTO THE LM USING A NON-MEDTRONIC BALLOON. IT WAS LATER DETAILED THAT THE STENT WAS STUCK IN THE NON-MEDTRONIC GUIDE EXTENSION CATHETER (GEC). THE STENT WAS PUSHED THROUGH WITH A NON-MEDTRONIC 1.0X10MM BALLOON BUT IT COULD NOT GET THE STENT DOWN THE VESSEL AND THE STENT COULD NOT BE PULLED BACK INTO THE GEC. IT TOOK A WHILE TO GET THE STENT TO DEPLOY, AS THE STENT WAS TRYING TO GET INTO A VESSEL BUT COULDN'T, AND ULTIMATELY ENDED UP IN THE LEFT MAIN (LM) ARTERY. IT WAS ATTEMPTED TO TAKE THE STENT OUT BUT IT COULDN'T. THE STENT WAS DEPLOYED AND SMASHED/CRUSHED IN THE LEFT MAIN (LM). THERE WAS NO RESISTANCE NOTED DURING WITHDRAWAL OF THE STENT DELIVERY SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356117 LAUNCHER 6F GUIDE CATHETER CATHETER, PERCUTANEOUS DQY MEDTRONIC, INC LA6EBU35

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention