BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1851649 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02253
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    June 5, 2007
    Report Date
    June 12, 2007
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE DEVICE WAS RETURNED DEPLOYED WITH 15 1/4" OF THE SUTURE PULLED OUT OF THE DEVICE (THE REMAINING PORTION WAS NOT RETURNED). THE ANTERIOR CUFF WAS CAPTURED AND STILL ATTACHED TO THE NEEDLE. THE POSTERIOR CUFF WAS NOT CAPTURED WITH ONE TAB BENT AND THE OTHER TWO INTACT. THIS FINDING IS CONSISTENT WITH A POSTERIOR CUFF MISS. THE POSTERIOR FOOT WAS EXAMINED FOR NEEDLE STRIKE MARKS AND NONE WERE DETECTED. THE DAMAGED CUFF TAB WITH TWO INTACT INDICATES THE NEEDLE STRUCK THE CUFF AT AN INCORRECT ANGLE STRIKING ONLY ONE TAB. THE CAUSE OF THE NEEDLE'S DEFLECTION IS UNDETERMINED. THE ORIGINAL PLUNGER WAS RE-INSERTED AND THE NEEDLE TRAJECTORY, DEPTH AND MANDREL TRAVEL WERE ACCEPTABLE. A ROOT CAUSE FOR THE DIFFICULTY ENCOUNTERED DURING NEEDLE PLUNGER REMOVAL AND THE SUTURE LINK BREAK COULD NOT BE DETERMINED. NO MALFUNCTION WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS DEVICE DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, DIFFICULTY WAS ENCOUNTERED DURING DEVICE REMOVAL. IN EACH INCIDENT, IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, A DILATOR WAS INSERTED INTO THE ACCESS PORTS AND THE DEVICE WAS REMOVED SUCCESSFULLY FROM THE PT'S ANATOMY. THE THUMB ADVANCER WAS PROXIMALLY RETRACTED, WHICH RELEASED THE DEVICE FROM THE TISSUE TRACT. HEMOSTASIS WAS ACHIEVED WITH THE CLIP. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 44037-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention