BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2183020 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05362
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 8, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND THAT THE PLUNGER WAS OUT OF THE DEVICE. THE PRE-FORMED KNOT WAS UNRAVELED AND THE POSTERIOR NEEDLE TIP WAS EXPOSED AT THE NEEDLE SLOT WITH THE RAIL END INSIDE THE TUBE. AS THE SUTURE WAS NOT RETRIEVED, THE KNOT WOULD NOT FORM TO ADVANCE TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL AS INTENDED. DURING THE INVESTIGATION, THE LEVER WAS OPENED AND CLOSED WITHOUT RESISTANCE. THE PLUNGER WAS INSERTED, THE LOCKING MECHANISM WAS CHECKED AND THE PLUNGER STAYED IN POSITION WHEN THE LEVER WAS CLOSED. THE PLUNGER WAS DEPLOYED SUCCESSFULLY. THERE WAS NO MANUFACTURING OR QUALITY DEFICIENCY DETECTED THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. EACH DEVICE WAS INSPECTED DURING MANUFACTURING WITH THE LEVER DEPLOYED TO ASSURE THE PLUNGER STAYED IN PLACE. A CAUSE FOR THE REPORTED DIFFICULTY LIFTING THE LEVER AND INABILITY TO PUSH TO PLUNGER DOWN TO DEPLOY THE NEEDLES COULD NOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT-HANDLING DATABASE INDICATED NO OTHER INCIDENTS FROM THIS LOT. THERE IS NO ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    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. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING THE PERCLOSE PROGLIDE AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE LEVER TO DEPLOY THE FOOT WAS DIFFICULT TO LIFT AND IT WAS NOT POSSIBLE TO PUSH THE PLUNGER DOWN TO DEPLOY THE NEEDLES. THE DEVICE WAS REMOVED AND HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WAS NO ADVERSE PATIENT SEQUELA. REPORTEDLY, THE PHYSICIAN IS TRAINED IN THE USE OF THE DEVICE. 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 040246H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OTHER: ASPIRIN