BEUDAMED
    FDA Adverse Event Summary report: N

    HS III PROXIMAL SEAL SYTEM 3.8MM

    MDR report key: 4241305 · Received September 4, 2014

    Report

    Report Number
    2242352-2014-01034
    Date Received
    September 4, 2014
    Date of Event
    July 10, 2013
    Report Date
    July 10, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED NO SIGNS OF CLINICAL USAGE OR EVIDENCE OF BLOOD. THE DELIVERY DEVICE WAS RETURNED OUTSIDE THE LOADING DEVICE. THE TENSION SPRING ASSEMBLY, ANCHOR TAB AND SEAL WERE INSIDE THE LOADING DEVICE. THE GREENSLIDE LOCK AND THE WHITE PLUNGER WERE DEPRESSED ON THE DELIVERY DEVICE. THIS FAILURE IS POTENTIALLY ATTRIBUTED TO USER TECHNIQUE. IT APPEARS THAT THE SEAL HAD BEEN PREMATURELY DEPLOYED IN THE LOADING DEVICE. AS STATED IN THE IFU, THE USER SHOULD ENSURE THAT THE LOCK IS LOCKED. IF THE LOCK IS UNLOCKED, CARE SHOULD BE TAKEN TO AVOID ANY ACCIDENTAL DEPRESSING OF THE PLUNGER. BASED UPON THE EVALUATION RESULTS, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED; HOWEVER IT WAS CONFIRMED FOR PREMATURE DEPLOYMENT. TWO (2) DEVICES WERE ORIGINALLY REPORTED. HOWEVER, THREE (3) DEVICES WERE RETURNED FOR THE REPORTED FAILURE. THIS IS DEVICE 3 OF 3. SEE MFR REPORT #2242352-2013-00723 AND #2242352-2013-01352 FOR INFORMATION REGARDING THE OTHER DEVICES. (B)(40.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, TO HEARTSTRING III SEALS FAILED TO LOAD PROPERLY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE HOSPITAL INTEND TO RETURN THE PRODUCTS IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542209 HS III PROXIMAL SEAL SYTEM 3.8MM CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 25069338

    Patients

    Seq Age Sex Outcome Treatment
    1 NI