BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELESCOPE GUIDE EXTENSION CATHETER

    MDR report key: 15508698 · Received September 29, 2022

    Report

    Report Number
    9612164-2022-03584
    Event Type
    Injury
    Date Received
    September 29, 2022
    Date of Event
    March 28, 2022
    Report Date
    September 29, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    UDI-DI
    00763000156954
    PMA / PMN Number
    K183353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TELESCOPE GEC RETURNED LOADED IN A NON-MEDTRONIC GUIDE CATHETER. A NON-MEDTRONIC STENT DELIVERY SYSTEM (SDS), LOADED ON AN UNKNOWN GUIDE WIRE, WAS IDENTIFIED LOADED IN THE TELESCOPE GEC. DURING ANALYSIS OF THE DEVICE, IT WAS POSSIBLE TO ADVANCE THE TELESCOPE GEC DISTALLY WITH DIFFICULTY DUE TO THE PRESENCE OF DRIED HARDENED BLOOD WITHIN THE LUMEN OF THE NON-MEDTRONIC GC. THE DEVICES WERE PLACED IN A WATER BATH AT 37°C FOR 24HRS TO DISPERSE THE BLOOD RESIDUE IN THE LUMENS OF THE DEVICES IN ORDER TO FACILITATE THE WITHDRAWAL OF THE DEVICES. POST REMOVAL OF THE DEVICES FROM THE WATER BATH, THE TELESCOPE GEC AND THE NON-MEDTRONIC SDS WAS RETRACTED THROUGH THE NON-MEDTRONIC GUIDE CATHETER, RESISTANCE WAS NOTED. DEFORMATION WAS NOTED TO THE STRUTS OF THE NON-MEDTRONIC STENT, WHICH INHIBITED WITH WITHDRAWAL OF THE SDS FROM THE TELESCOPE GEC. KINKS WERE EVIDENT TO THE PUSH MEMBER OF THE TELESCOPE GEC. DEFORMATION WAS EVIDENT TO THE TIP OF THE TELESCOPE GEC. NO DEFORMATION WAS NOTED TO THE ENTRY PORT OF THE TELESCOPE GEC. THE INNER LUMEN OF THE TELESCOPE GEC COULD NOT BE VERIFIED TO 0.0540 INCHES DUE TO THE DEFORMATION TO THE DISTAL TIP OF THE DEVICE. NO OTHER DEFORMATION EVIDENT TO THE REMAINDER OF THE DEVICE. THIS EVENT HAS BEEN PREVIOUSLY REPORTED FOR RONYX30015UX UNDER MDR REPORT NUMBER 9612164-2022-01332. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT AND ONE TELESCOPE GUIDE EXTENSION CATHETER TO TREAT A NON-TORTUOUS, MODERATELY CALCIFIED LESION WITH 95% STENOSIS IN THE PROXIMAL OF THE CIRCUMFLEX (CX) ARTERY. BOTH DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE TELESCOPE WAS PREPPED PER IFU WITH NO ISSUES NOTED. THE STENT WAS NEGATIVELY PREPPED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH A 3.0X12MM BALLOON. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE TELESCOPE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION. THE TELESCOPE WAS THEN USED FOR EXTRA SUPPORT BUT THE STENT WAS STILL UNSUCCESSFUL. THERE WERE NO ISSUES NOTED DURING INSERTION OF THE RESOLUTE ONYX INTO THE TELESCOPE GEC. STENT DISLODGEMENT OCCURRED WHEN REMOVING THE STENT BACK INTO THE TELESCOPE TIP. THE PHYSICIAN INITIALLY TRIED TO USE THE STENT BALLOON TO REMOVE THE DISLODGED STENT BUT THIS WAS UNSUCCESSFUL. A 1.5MM BALLOON WAS THEN DILATED INSIDE THE DISLODGED STENT AND THE DISLODGED STENT WAS SUCCESSFULLY PULLED BACK INTO THE NON-MEDTRONIC GUIDE CATHETER AND REMOVED. THE PATIENT IS ALIVE WITH NO FURTHER INJURY. IT WAS STATED THAT THERE WAS NO ALLEGED ISSUE AGAINST THE TELESCOPE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539070 TELESCOPE GUIDE EXTENSION CATHETER CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND TELE6F 0010616044 00763000156954

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention