BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2103209 · Received May 25, 2011

    Report

    Report Number
    2024168-2011-03695
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS TO BE RETURNED FOR EVALUATION; HOWEVER, IT WAS INADVERTENTLY MISPLACED DURING TRANSIT. WITHOUT THE PRODUCT A PHYSICAL EXAMINATION COULD NOT BE PERFORMED, WHICH LIMITED THE SCOPE OF THE INVESTIGATION. NO DETERMINATION CAN BE MADE AS TO THE CONTRIBUTING FACTORS TO THE REPORTED DISCREPANCY. A SUTURE BREAK CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO, MANUFACTURING, TOO MUCH TENSION APPLIED, OR THE SUTURE WAS NICKED. WHETHER THESE CONDITIONS PLAYED A ROLE IN THE EXPERIENCED EVENT CANNOT BE VERIFIED. BASED ON THE INFORMATION AVAILABLE, THE INSPECTION CRITERIA AND THE REVIEW OF THE LOT HISTORY RECORD THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD REVEALED NO MANUFACTURING RELATED NONCONFORMING MATERIAL RECORD ASSOCIATED WITH THIS LOT FOR THIS INCIDENT. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENT REPORTED SUTURE BREAK WITH THIS LOT NUMBER. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS A SAMPLING OF SUTURES ARE TESTED UNDER STRESS FOR DIAMETER MEASUREMENTS BEFORE RELEASE TO MANUFACTURING. IN ADDITION, A SAMPLING OF FINISHED DEVICES IS ALSO TESTED TO VERIFY THE FUNCTIONALITY OF THE 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 (CORONARY) PROCEDURE. REPORTEDLY, THE SUTURE BROKE. THE METHOD OF ACHIEVING HEMOSTASIS IS NOT SPECIFIED. 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 040036H

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention