BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING PROXIMAL SEAL, 4.5 MM

    MDR report key: 1900103 · Received October 22, 2010

    Report

    Report Number
    2242352-2010-02760
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 16, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K022880
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: VISUAL INSPECTION REVEALED THAT THE SEAL WAS COMPLETELY UNRAVELED EXCEPT FOR THE LAST WINDING, THE SEAL WAS SOMEWHAT TWISTED IN THE CENTER, AND THE SAFETY TAB WAS AT THE END OF THE SEAL. THE SEAL WAS OUTSIDE OF THE DELIVERY TUBE, AND WAS RECEIVED SEPARATE FROM THE SPRINGS AND THE BLUE STRING WHICH WAS CUT. THE COLLAR WAS NOT PRESENT, THE PLUNGER HAD BEEN DEPRESSED. THE DEVICE WAS VERY BLOODY. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT FOR "SEAL CRACKED DURING USE" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEARTSTRING II PROXIMAL SEAL CRACKED. A REPLACEMENT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL REPORTED NO PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTRING PROXIMAL SEAL, 4.5 MM PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC HS-1045 25010602

    Patients

    Seq Age Sex Outcome Treatment
    1 NA