BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2861377 · Received December 7, 2012

    Report

    Report Number
    2024168-2012-07711
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 14, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE WAS DISCARDED AND IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. HOWEVER, EIGHT UNUSED, STERILE PROGLIDE DEVICES WITH THE SAME LOT NUMBER, 21003J1, AS THE COMPLAINT DEVICE WERE RETURNED FOR EVALUATION. THE DEVICES PASSED FUNCTIONAL TESTING WITH ACCEPTABLE RESULTS. NO MANUFACTURING OR ABNORMAL OBSERVATIONS WERE DETECTED. A CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED BASED ON THE INVESTIGATION FINDINGS FROM THE TESTED SAMPLE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT-HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THAT THE DEVICE WAS DISCARDED AND NOT RETURNING FOR EVALUATION; HOWEVER, THE CUSTOMER HAS RETURNED NINE UNUSED, STERILE, SAMPLE DEVICES PART NUMBER ((B)(4)) AND LOT NUMBERS (20924J1 AND 21003J1) FOR EVALUATION. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER PERCLOSE PROGLIDE DEVICES, ARE BEING FILED UNDER SEPARATE MEDWATCH MANUFACTURER REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DIAGNOSTIC CORONARY ANGIOGRAM, ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, A NEEDLE-TO-CUFF MISS OCCURRED. WHEN THE NEEDLE PLUNGER WAS REMOVED, NO SUTURE WAS PRESENT. THE DEVICE WAS REMOVED AND THREE ADDITIONAL PROGLIDE DEVICES WERE ATTEMPTED, BUT ALSO RESULTED IN NEEDLE-TO-CUFF MISSES. A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. 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 21003J1

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention SHEATH: 6-FRENCH. ANGIOMAX