BEUDAMED
    FDA Adverse Event Death Summary report: N

    TELESCOPE GUIDE EXTENSION CATHETER

    MDR report key: 22640884 · Received July 29, 2025

    Report

    Report Number
    9612164-2025-03680
    Event Type
    Death
    Date Received
    July 29, 2025
    Date of Event
    July 10, 2025
    Report Date
    October 7, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K183353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 GEC WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. THE LESION BEING TREATED HAD MODERATE TO SEVERE TORTUOSITY AND WAS SEVERELY CALCIFIED LOCATED IN THE MID CIRCUMFLEX (CX) ARTERY WITH 70% STENOSIS, ESTIMATED 3.0MM VESSEL SIZE, AN IVUS WOULD NOT DELIVER. IT WAS ATTEMPTED TO DELIVER THE 2.5X33MM NON-MEDTRONIC STENT WITHOUT THE GEC, HOWEVER THIS WAS UNSUCCESSFUL AND THE GEC WAS RE-DEPLOYED USING NC BALLOON ANCHOR TECHNIQUE TO ADVANCE. THE STENT WAS THEN DELIVERED THROUGH THE GEC TO THE INTENDED DEPLOYMENT SITE WITHOUT RESISTANCE AND THE STENT WAS ABLE TO PASS DISTAL TO THE TIP OF THE TELESCOPE DEVICE. THE STENT WAS POSITIONED BUT IT WAS NOT DEPLOYED. THE GEC WAS BEING WITHDRAWN WITH CONSTANT TRACTION WHEN THERE WAS A DETACHMENT. HOWEVER, IT WAS CLEAR THAT IT WAS WEDGED AND IT WAS NOT COMING WITH USUAL EFFORTS. THE STENT GUIDE AND WIRE WERE REMOVED EN BLOC IN FULL. THE PATIENT WAS TRANSFERRED TO THE SURGICAL THEATRE FOR CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE TO REMOVE THE DETACHED TIP BUT THE TIP WAS NOT REMOVED. NO OTHER MEDTRONIC DEVICES WERE USED IN THE PROCEDURE. NO PREVIOUS MEDTRONIC STENTS OR DEVICES IMPLANTED IN THE PATIENT. THE TELESCOPE GEC DID NOT CAUSE OR CONTRIBUTE TO THE DEATH OF THE PATIENT. - PATIENT'S AGE AND SEX - PATIENT'S MEDICAL HISTORY PRODUCT ANALYSIS: UPON DEVICE RETURN, IT WAS NOTED THAT THE PUSH MEMBER WAS KINKED AND THE ON RAMP WAS DEFORMED. THE LUMEN WAS STRETCHED ALONG ITS ENTIRE LENGTH. THE DISTAL TIP WAS DETACHED FROM THE DEVICE. THE REMAINING TIP MATERIAL WAS JAGGED AND UNEVEN. NO OTHER DAMAGE NOTED. 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: ANNEX D CODE. CORRECTION: ANNEX A CODE. SECTION H2. "IF FOLLOW-UP, WHAT TYPE?" DEVICE EVALUATION TICKED. SECTION H3. "DEVICE EVALUATED?:" YES. 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 PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE INVOLVING ONE TELESCOPE GUIDE EXTENSION CATHETER (GEC) A DETACHMENT OF THE TIP OF THE DEVICE OCCURRED. THE GEC WAS INSPECTED PRIOR TO USE AND PREPPED PER IFU. THE LESION BEING TREATED HAD MODERATE TO SEVERE TORTUOSITY AND WAS SEVERELY CALCIFIED LOCATED IN THE MID CIRCUMFLEX (CX) ARTERY WITH 70% STENOSIS. THERE WAS POOR GUIDE SUPPORT WAS WITH ANGULATED CX. THE GEC WAS BEING USED TO FACILITATE NC BALLOON POSITIONING. IT WAS ATTEMPTED TO DELIVER THE STENT WITHOUT THE GEC HOWEVER THIS WAS UNSUCCESSFUL AND THE GEC WAS RE-DEPLOYED USING NC BALLOON ANCHOR TECHNIQUE TO ADVANCE. THE GEC WAS DELIVERED ACROSS THE STENOSIS WITHOUT DIFFICULTY FOLLOWING EXPANSION OF NC BALLOON AT NOMINAL PRESSURE IN THE HEAVILY CALCIFIED SEGMENT. MILD RESISTANCE WELL WITHIN NORMAL PRACTICE WAS EXPERIENCED ADVANCING THE GEC TO DELIVER THE GEC FOR ANCHOR SUPPORT WITH NO EXCESSIVE FORCE USED. THE STENT WAS THEN DELIVERED THROUGH THE GEC TO THE INTENDED DEPLOYMENT SITE WITHOUT RESISTANCE. IT WAS THEN ATTEMPTED TO WITHDRAW THE GEC OVER THE STENT IN ORDER TO DEPLOY THE STENT HOWEVER THE GEC WAS UNABLE TO BE WITHDRAWN. ATTEMPTS TO REMOVE THE STENT AND GEC EN BLOC FAILED. THERE WAS NO INTERACTION BETWEEN THE STENT AND THE GEC. A DETACHMENT OF THE SOFT POL YMER TIP OF THE GEC PROXIMAL TO THE RADIO-OPAQUE MARKER OCCURRED. THE STENT GUIDE AND WIRE WERE REMOVED EN BLOC. A NEW ACCESS WAS MADE AND THE GEC TIP WAS REWIRED WITH DIFFICULTY. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE GEC USING DISTAL NC BALLOON WHICH WAS INFLATED HOWEVER THIS WAS UNSUCCESSFUL. IT WAS UNABLE TO WIRE AROUND THE TIGHT STENOSIS PRESENT. THE PROCEDURE WAS ABANDONED. THE PATIENT WAS HAEMODYNAMICALLY STABLE, WITH NO ST ELEVATION, TIMI 3 FLOW IN VESSEL AT THE END OF THE PROCEDURE. THE PATIENT WAS TRANSFERRED TO THE SURGICAL THEATRE FOR CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE TO REMOVE THE DETACHED TIP. CARDIAC SURGERY WAS WAS ALSO INDICATED FOR THE PATIENT DUE TO SEVERE LEFT ANTERIOR DESCENDING (LAD) ARTERY, CX AND RIGHT CORONARY ARTERY (RCA). THE PATIENT SUBSEQUENTLY DIED AS A RESULT OF POST-OPERATIVE COMPLICATIONS OF THE CABG SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2549407 TELESCOPE GUIDE EXTENSION CATHETER CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND TELE6F 0012834108

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention| D