BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UICHIN EVO HEART POSITIONER

    MDR report key: 1780955 · Received July 26, 2010

    Report

    Report Number
    2135394-2010-00011
    Event Type
    Injury
    Date Received
    July 26, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 8, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    MWS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL INSPECTION SHOWED NO OUTWARD SIGNS OF PHYSICAL DAMAGE OR ABNORMALITIES. THERE WERE NO ROUGH SPOTS DETECTED ON THE HEADLINK OR CAPTURE FOAM. REVIEW OF MFG RECORDS FOR THIS PRODUCT DID NOT REVEAL ANY ABNORMALITIES OR NON-CONFORMANCES. CONCLUSION: THE REASON FOR RETURN COULD NOT BE CONFIRMED. ANALYSIS DID NOT REVEAL ANY AREAS ON THE URCHIN EVO THAT WOULD HAVE CAUSED DAMAGE TO THE HEART. SINCE THE DEVICE WAS TESTED AND FOUND TO BE FREE OF ABNORMALITIES AND ROUGH SPOTS, IT IS LIKELY THAT THE ROOT CAUSE OF THIS EVENT IS SIMPLY THE PT'S FRAGILE HEART TISSUE. IT WAS ALSO REPORTED THAT THE CUSTOMER RECENTLY SWITCHED TO THE MODEL HP3500 PRODUCT FROM A COMPETITOR'S. IT IS POSSIBLE THAT THE CUSTOMER IS USED TO USING A SLIDING MOTION AS SOME COMPETITIVE PRODUCTS FUNCTION. HOWEVER, WITH THE HP3500, THE DEVICE IS SUPPOSED TO "LOCK" IN PLACE. MOVING THE DEVICE IN A SLIDING MOTION AT HIGH SUCTION COULD POTENTIALLY DAMAGE A PT'S HEART TISSUE. INSTRUCTIONS FOR USE, DOCUMENT NUMBER: (B)(4), REV A DOCUMENT'S CONTRAINDICATIONS SUCH AS FRAGILE TISSUE.

    Description of Event or Problem · 1

    MEDTRONIC REC'D INFO THAT AFTER PLACING THIS URCHIN DEVICE TO THE APEX, THE SURGEON WAS MOVING THE HEART AND DAMAGE TO THE HEART TISSUE RESULTED. THE SURGEON COMMENTED THAT THEY FELT THE DAMAGE WAS DUE TO THE PT'S FRAGILE HEART TISSUE. THE DAMAGED TISSUE WAS ABLE TO BE REPAIRED WITHOUT FURTHER COMPLICATIONS REPORTED. THE URCHIN DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UICHIN EVO HEART POSITIONER MWS MEDTRONIC PERFUSION SYSTEMS HP3500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R