BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE GUIDE EXTENSION CATHETER

    MDR report key: 13838555 · Received March 21, 2022

    Report

    Report Number
    9612164-2022-01065
    Event Type
    Malfunction
    Date Received
    March 21, 2022
    Date of Event
    November 24, 2021
    Report Date
    March 28, 2022
    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 TELESCOPE GUIDE EXTENSION CATHETER (GEC) RETURNED LOADED IN A NON-MDT GUIDE CATHETER ALONG WITH A RESOLUTE ONYX DES (RONYX). ON RETURN OF THE DEVICE THE TELESCOPE GEC TIP WITHIN THE LUMEN OF THE NON-MDT GUIDE CATHETER. THE DEVICES WERE ADVANCED DISTALLY WITH NO ISSUES. THE TELESCOPE GEC WAS NOT ENTRAPPED WITHIN THE GUIDE CATHETER. ON ADVANCEMENT OF THE TELESCOPE GEC, THE DISTAL COIL OF THE TELESCOPE GEC WAS OBSERVED TO BE EXPOSED. DUE TO THE BUNCHING OF THE BALLOON MATERIAL, THE RONYX COULD NOT BE RETRACTED THROUGH THE TELESCOPE GEC. THE BALLOON OF THE RONYX WAS INFLATED AND THEN DEFLATED. THE BALLOON DEFLATED INTO A FLAT PROFILE. DURING THE RETRACTION OF THE RONYX THE COIL AND TIP MATERIAL COMPRESSED HOWEVER, THE MATERIAL RETURNED TO ITS FORMATION, FORCE WAS REQUIRED DURING RETRACTION. DEFORMATION WAS EVIDENT TO THE TIP OF THE TELESCOPE GEC. DEFORMATION WAS ALSO NOTED TO THE ENTRY PORT AND ON-RAMP. THE INNER LUMEN WAS VERIFIED TO 0.0540 INCHES BY PASSING A 0.0540 INCH LUMEN PATENCY BALL THROUGH THE LUMEN OF THE TELESCOPE GEC, SOME RESISTANCE WAS NOTED WHEN PASSING THE LUMEN PATENCY BALL THROUGH ENTRY PORT. OD MEASUREMENTS; ENTRY PORT OD 0.06626 INCHES; PROXIMAL BOND OD = 0.06670 INCHES; DISTAL BOND OD = 0.06591 INCHES; DISTAL TIP OD = 0.06893 INCHES. SPECIFICATIONS: MAX OD = 0.06970 INCHES NO OTHER DEFORMATION NOTED TO THE REMAINDER OF THE DEVICE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    FDC CODE ADDED. CORRECTION: FACILITY ADDRESS AND PHONE NUMBER MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    A 6F TELESCOPE GUIDE EXTENSION CATHETER WAS USED DURING A PROCEDURE TO TREAT A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LESION. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE DEVICE WAS REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE DEVICE WAS NOT EXCESSIVELY TORQUED. THE TELESCOPE DEVICE WAS USED TO PLACE A RESOLUTE ONYX STENT AT THE LESION. IT WAS REPORTED THAT WHEN ATTEMPTING TO REMOVE THE DELIVERY SYSTEM STRONG RESISTANCE WAS FELT WITH THE 7F NON-MEDTRONICGUIDE CATHETER SO THE WHOLE SYSTEM WAS REMOVED TOGETHER. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556846 TELESCOPE GUIDE EXTENSION CATHETER CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND 0010704660

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown