BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 19325013 · Received May 15, 2024

    Report

    Report Number
    3002648230-2024-00215
    Event Type
    Injury
    Date Received
    May 15, 2024
    Date of Event
    March 27, 2024
    Report Date
    May 15, 2024
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ID: 990060-020, PRODUCT TYPE: MAPPING CATHETER; PRODUCT ID: AFAPRO28, PRODUCT TYPE: BALLOON 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE PATIENT EXPERIENCED COUGHING WHILE THE LEFT SUPERIOR PULMONARY VEIN (LSPV) WAS ABLATED. BLEEDING FROM INSIDE THE MOUTH OR NEAR THE THROAT WAS LATER DISCOVERED WHILE SUCTIONING. IT WAS SURMISED THAT ANOTHER MANUFACTURER'S ESOPHAGEAL TEMPERATURE CATHETER MAY HAVE CONTRIBUTED TO THE BLEEDING. THE CASE WAS COMPLETED WITH CRYO. THE BLEEDING WAS DETERMINED TO BE HEALED, "AFTER REMOVAL OF THE RESPIRATORY ORGANS AFTER THE SURGERY," HOWEVER, BLOOD SPUTUM APPEARED AND A HEMATOMA NEAR THE LEFT LUNG WAS OBSERVED ON A COMPUTERIZED TOMOGRAPHY (CT) SCAN. IT WAS SURMISED THERE WAS A PERFORATION FROM THE MAPPING CATHETER. THE PATIENT WAS SUBJECTED TO EXTENDED HOSPITALIZATION. THE BLEEDING STOPPED AND THE HEMATOMA IMPROVED SO THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FIVE DAYS POST-PROCEDURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THAT THE BALLOON CATHETER AND SHEATH WERE NOT ADVANCED AS DEEPLY AS THE MAPPING CATHETER, AND THE MAPPING CATHETER WAS INSERTED AND REMOVED SEVERAL TIMES TO ADVANCE THE DEPTH. IT WAS ALSO REPORTED THAT "REMOVAL OF RESPIRATORY ORGANS" MEANT REMOVAL OF THE BREATHING EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440934 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12 0012121333

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| L