BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH CONTOUR¿ STEERABLE SHEATH

    MDR report key: 20392115 · Received October 7, 2024

    Report

    Report Number
    9612164-2024-04575
    Event Type
    Injury
    Date Received
    October 7, 2024
    Date of Event
    September 30, 2024
    Report Date
    November 29, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DRA
    UDI-DI
    00763000234928
    PMA / PMN Number
    K232321
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: AFAPRO28, PRODUCT TYPE: BALLOON CATHETER; PRODUCT ID: 990032-020, PRODUCT TYPE: MAPPING 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

    PRODUCT EVENT SUMMARY: THE 12FCC13 SHEATH WITH LOT NUMBER 0012250161 WAS RETURNED AND ANALYZED. VISUAL INSPECTION OF THE HANDLE AREA WAS PERFORMED. THE INSPECTION IDENTIFIED A KINK AT THE SIDE PORT TUBE. THE TIP OF THE SHEATH WAS INTACT WITH NO ANOMALY. THE STEERING MECHANISM AND DEFLECTION TEST WERE PERFORMED. NO ANOMALY WAS DISCOVERED. THE LAB TEST DILATOR WAS INSERTED INTO THE SHEATH AND RETRACTED SEVERAL TIMES, WITHOUT ANY FRICTION. THE LAB TEST DILATOR WAS SNAP-LOCKED TO THE SHEATH AND WAS TIGHT. VISUAL INSPECTION AND MAGNIFYING WITH A HIGH-RESOLUTION MICROSCOPE SHOWED THE VALVE HOUSING WAS INTACT WITHOUT ANY ISSUE. THE PERFORMANCE TEST WITH SENTINEL BLACKBELT LEAK TESTER WAS PERFORMED. THE PRESSURE TEST WITH 45 POUNDS PER SQUARE INCH GAUGE (PSIG) SHOWED THE PRESSURE DECAY IN THE DEVICE WAS 0.07155 PSIG AND IN AN ACCEPTABLE RANGE (SHOULD BE BETWEEN -0.3 AND 0.3 PSIG). THE VACUUM TEST WITH A NEGATIVE PRESSURE OF 8.5 PSIG SHOWED THE PRESSURE DECAY IN THE DEVICE WAS 0.00637 PSIG AND IN AN ACCEPTABLE RANGE (SHOULD BE BETWEEN -0.3 AND 0.3 PSIG). IN CONCLUSION, THE CLINICAL ISSUE OF EFFUSION OCCURRED DURING THE PROCEDURE. ADDITIONALLY, THE SHEATH FAILED THE RETURNED PRODUCT INSPECTION DUE TO A KINK ON THE SIDE PORT TUBE. 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, TRANSSEPTAL ACCESS WAS DIFFICULT TO OBTAIN WITH THE SHEATH. FOLLOWING THE LAST ABLATION, AN EFFUSION AROUND THE VENTRICLE WAS OBSERVED. PERICARDIOCENTESIS WAS SUBSEQUENTLY PERFORMED. THE CASE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247196 FLEXCATH CONTOUR¿ STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC IRELAND 12FCC13 0012250161 00763000234928

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention SEE H11.