BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2132859 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04320
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ESTIMATE AGE (PATIENT WAS REPORTED TO BE IN HIS (B)(6)). ESTIMATE WEIGHT (PATIENT WAS REPORTED TO WEIGH OVER (B)(6)). ESTIMATE DATE (REPORTED TO HAVE OCCURRED IN THE LAST WEEK). WITHOUT THE PRODUCT TO EXAMINE, NO DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE REPORTED INCIDENT. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY MANUFACTURING RELATED NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. BASED ON THE INFORMATION PROVIDED AND THE REVIEW OF THE LOT HISTORY RECORD, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT, THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    THE OPERATOR FOR THIS DEVICE IS A TECHNICIAN WHO IS TRAINED IN THE USE OF A PERCLOSE PROGLIDE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER DEPLOYING THE DEVICE, THE KNOT WAS ATTEMPTED TO BE ADVANCED, WHEN EXCESSIVE BLEEDING WAS OBSERVED AND THE SUTURE CAME OUT OF THE ARTERY. MANUAL COMPRESSION AND A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention