BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1842405 · Received September 18, 2010

    Report

    Report Number
    2953144-2010-01992
    Event Type
    Injury
    Date Received
    September 18, 2010
    Date of Event
    January 28, 2008
    Report Date
    February 1, 2008
    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
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (PT SELECTION). EVAL SUMMARY: THE DEVICE WAS RECEIVED WITH THE ENTIRE MONOFILAMENT EXPOSED AT THE POSTERIOR FOOT. THE POSTERIOR CUFF WAS ENGAGED TO THE POSTERIOR NEEDLE TIP BUT REMAINED INSIDE THE POSTERIOR FOOT POCKET. THE ANTERIOR AND POSTERIOR CUFFS REMAINED ATTACHED TO THE LINK. THE ANTERIOR NEEDLE TIP WAS DETACHED FROM THE ANTERIOR CUFF AND THE ANTERIOR CUFF TABS APPEARED DAMAGED. BASED ON THE FINDINGS, THE POSTERIOR CUFF FAILED TO BE COMPLETELY EJECTED FROM THE FOOT PLUNGER. IT APPEARED THAT THE POSTERIOR CUFF WAS PULLED BACK INTO THE POSTERIOR CUFF POCKET AS THE PLUNGER WAS BEING PULLED BECAUSE, THERE WAS EVIDENCE OF MARKS ON THE FOOT. THE DAMAGED ANTERIOR CUFF TABS WERE THE RESULT OF THE ANTERIOR NEEDLE TIP DISENGAGING FROM THE ANTERIOR CUFF. THE ANTERIOR CUFF TO NEEDLE DETACHMENT WAS A DIRECT RESULT OF THE POSTERIOR CUFF NOT BEING EJECTED FROM THE POSTERIOR FOOT POCKET. DURING TESTING, THE NEEDLE PLUNGER WAS REINSERTED INTO THE DEVICE RESULTING IN ACCEPTABLE PUSH MANDREL TRAVEL; THEREFORE, A ROOT CAUSE FOR THE POSTERIOR CUFF NOT BEING EJECTED FROM THE POSTERIOR FOOT POCKET COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, DURING DEVICE INSERTION, DIFFICULTY WAS ENCOUNTERED. A POSSIBLE CUFF MISS OCCURRED. A SECOND DEVICE WAS USED. IT WAS BELIEVED THAT FEMORAL ARTERY SCARRING, PERIPHERAL VASCULAR DISEASE, AND OBESITY CONTRIBUTED TO THE PRODUCT EXPERIENCE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 61031-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention