BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1022108 · Received March 25, 2008

    Report

    Report Number
    2953144-2008-00200
    Event Type
    Malfunction
    Date Received
    March 25, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 31, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND A POSTERIOR FOOT AND POSTERIOR NEEDLE TIP BREAKAGE. THE PLUNGER, SUTURE, LINK, CUFFS AND ANTERIOR NEEDLE WERE NOT RETURNED WITH THE DEVICE. WE WERE UNABLE TO DETERMINE THE ROOT CAUSE BASED ON THE INVESTIGATION FINDINGS. NO MFG ISSUES WERE DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: FOOT BREAK. TIME OF MALFUNCTION: UNKNOWN. SYMPTOMS/AE: HEMOSTASIS ACHIEVED BY UNKNOWN METHOD. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE DEVICE WAS RETURNED STATING "DEVICE FAILED". DETAILED CASE DESCRIPTION IS UNKNOWN BY THE SITE REPORTER. HEMOSTASIS WAS ACHIEVED BY UNKNOWN METHOD. DURING DEVICE EVALUATION ON 2/29/2008, A POSTERIOR FOOT BREAK WAS FOUND. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR REDWOOD CITY NA 57007-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK