BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1994192 · Received February 16, 2011

    Report

    Report Number
    2024168-2011-00941
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. A SUTURE MISLOCATION CAN OCCUR DUE TO A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO, THE ROTATION OF THE DEVICE DURING PLUNGER/NEEDLE DEPLOYMENT AND FAILURE TO MAINTAIN ADEQUATE FOOT POSITION AGAINST THE ARTERIAL WALL. THE RETURN OF PROGLIDE DEVICE MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE EXPERIENCED CUFF MISS. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, A SAMPLING OF FINISHED DEVICES IS ALSO TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED EXPERIENCE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    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 AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER DEPLOYMENT OF THE SUTURES THE LEVER WAS LOWERED FOR DEVICE REMOVAL IT WAS NOTICED THAT THE KNOT WAS HANGING LOOSE OUTSIDE THE VESSEL. A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 940406H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ANGIOMAX