BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE GUIDE EXTENSION CATHETER

    MDR report key: 21321452 · Received February 6, 2025

    Report

    Report Number
    9612164-2025-00627
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    December 24, 2024
    Report Date
    March 4, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K183353
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS : THE NON-MEDTRONIC DEVICE DID NOT RETURN. THERE DID NOT APPEAR TO BE ANY DEVICE ENTRAPPED. WHITE PLASTIC MATERIAL WAS FOUND IN THE LUMEN WHEN A MANDREL WAS ADVANCED THROUGH. THE DEVICE RETURNED WITH DEFORMATION TO THE ON RAMP. THE INNER LUMEN OF THE TELESCOPE GEC WAS VERIFIED, LUMEN PATENCY BALL THROUGH THE KINK ON THE LUMEN OF THE TELESCOPE GEC. 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

    ADDITIONAL INFORMATION: NO DAMAGE WAS OBSERVED ON THE NON-MEDTRONIC ATHERECTOMY DEVICE. PRODUCT ANALYSIS: THE FOREIGN WHITE PLASTIC MATERIAL FROM INSIDE THE TELESCOPE DEVICE WAS SENT FOR FTIR TESTING. THE SUSPECT SAMPLE WAS COMPARED AGAINST LIBRARY DATABASE. THE LIBRARY SEARCH RETURNED WEAK SPECTRAL MATCHES THAT WERE NOT SPECTRALLY SIMILAR. SAMPLE AND WHITE ACETAL CONTROL DID NOT SHOW SPECTRAL SIMILARITIES. CORRECTION: PHONE NUMBER. 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 A 7F TELESCOPE GUIDE EXTENSION CATHETER (GEC) A NON-MEDTRONIC CORONARY ORBITAL ATHERECTOMY SYSTEM DEVICE WAS INSERTED USING THE TELESCOPE GEC, BUT THE DEVICE GOT CAUGHT INSIDE THE JACKET OF THE TELESCOPE GEC AND COULD NOT BE ADVANCED. RESISTANCE WAS ENCOUNTERED DURING USE WHEN THE NON-MEDTRONIC DEVICE WAS INSERTED INTO THE CATHETER LUMEN. THE USE OF TELESCOPE GEC WAS DISCONTINUED, AND THE THE NON-MEDTRONIC DEVICE WAS ADVANCED WITHOUT THE TELESCOPE GEC TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING AND PREPPED PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351790 TELESCOPE GUIDE EXTENSION CATHETER CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND TELE7F 0012342860

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown