BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXCATH CONTOUR¿ STEERABLE SHEATH

    MDR report key: 21819612 · Received April 10, 2025

    Report

    Report Number
    9612164-2025-01873
    Event Type
    Death
    Date Received
    April 10, 2025
    Date of Event
    April 7, 2025
    Report Date
    April 28, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DRA
    PMA / PMN Number
    K232321
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 900310; PRODUCT TYPE: INTEGRATED DILATOR/NEEDLE PRODUCT ID NON-MEDTRONIC SL0; PRODUCT TYPE: SHEATH PRODUCT ID PSCC100; PRODUCT TYPE: LOOP CATHETER. 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

    UPDATED B5.DESC EVT PROBLEM UPDATED H6.PATIENT CODES (IME/ANNEX E). 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 CARDIAC ABLATION PROCEDURE, IT WAS DIFFICULT TO INSERT ANOTHER MANUFACTURER'S SHEATH INTO THE GROIN; THE TIP OF THE SHEATH WOULD BECOME JAMMED UPON INSERTION. THE SHEATH WAS REPLACED AND THE PROCEDURE CONTINUED AS EXPECTED. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED AND A HEART CATHETER WAS USED, BUT NO FINDINGS WERE REVEALED. A COMPLICATION OCCURRED IN THE VASCULATURE IN THE GROIN AREA WHILE ATTEMPTING VASCULAR ACCESS. THIS LED TO A SIGNIFICANT VENOUS BLEED. CARDIOPULMONARY RESUSCITATION WAS ADMINISTERED, AND BLOOD TRANSFUSIONS WERE GIVEN, BUT THE BLEEDING WAS UNABLE TO BE STOPPED. THE PROCEDURE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT WAS THEN ADMITTED TO THE INTENSIVE CARE UNIT AND LATER EXPIRED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEFT SUPERIOR PULMONARY VEIN (LSPV), LEFT INFERIOR PULMONARY VEIN (LIPV) AND RIGHT SUPERIOR PULMONARY VEIN (RSPV) WERE ABLATED AND THEN THE PATIENT'S BLOOD PRESSURE DROPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911775 FLEXCATH CONTOUR¿ STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC IRELAND 10FCC13

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Death SEE H11...