BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6 FR. SMC SYSTEM

    MDR report key: 557586 · Received December 1, 2004

    Report

    Report Number
    2953144-2004-00190
    Event Type
    Injury
    Date Received
    December 1, 2004
    Date of Event
    October 14, 2004
    Report Date
    November 4, 2004
    Manufacturer
    PERCLOSE, INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN PERFORMED AN ARTERIOTOMY CLOSURE WITH THE PERCLOSE AT (CLOSER AK) DEVICE FOLLOWING AN INTERVENTIONAL PROCEDURE. NO DIFICULTIES WERE EXPERIENCED WITH THE PROCEDURE AND HEMOSTASIS WAS ACHIEVED. THE PT IS DIABETIC AND PROPHYLACTIC ANTIBIOTICS WERE GIVEN AFTER THE CASE. REPORTEDLY THE PT WAS EXPERIENCING CHILLS AND "SPIKED A TEMPERATURE" BY THE END OF THE DAY. UNSPECIFIED "CULTURES" WERE DONE AND TESTED NEGATIVE. THE PT WAS KEPT IN THE HOSP OVERNIGHT AND WAS DISCHARGED THE FOLLOWING DAY. TWO WEEKS LATER THE PT RETURNED TO THE HOSP WITH A HEMATOMA OF UNK SIZE AND "SOME TREATMENT" WAS GIVEN; THE PT WAS DISCHARGED HOME THAT SAME DAY. THE NEXT DAY THE PT RETURNED TO THE HOSP AND WAS ADMITTED. THE PT WAS IN 11/20004. THE VASCULAR SURGEON SAID, "THE ARTERY WAS A NECROTIC MESS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6 FR. SMC SYSTEM SUTURE MEDIATED CLOSURE MGB PERCLOSE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R