BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2192286 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05523
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 12, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 CUSTOMER REPORTED THAT THE DEVICE WAS DISCARDED, THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONTINUED BLEEDING CAN BE INFLUENCED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO: MANUFACTURING, PATIENT ANATOMICAL CONDITION, AND OR USER TECHNIQUE. IT WAS REPORTED THAT THERE WAS NO CALCIFICATION, AND NO INFORMATION WITH RESPECT TO USER TECHNIQUE WAS PROVIDED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, WHICH MAY HAVE ASSISTED IN THE INVESTIGATION. IT WAS INDICATED THAT ALL DEPLOYMENTS STEPS WERE COMPLETED AND A SPECIFIC FAILURE MODE FOR THE DEVICE WAS NOT REPORTED; THEREFORE, IT IS NOT POSSIBLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED CONTINUED BLEEDING. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY RELEVANT NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. DEVICES ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION, SAMPLINGS OF FINISHED DEVICES ARE DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE, INCLUDING PROPER SUTURE PLACEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF A RIGHT COMMON FEMORAL ARTERY (RCFA) AFTER AN INTERVENTIONAL PROCEDURE USING A PROGLIDE DEVICE. REPORTEDLY, ALL THE DEPLOYMENT STEPS WERE COMPLETED; HOWEVER, BLEEDING STILL CONTINUED AND A 7FR. SHEATH WAS PLACED FOLLOWED BY MANUAL ARTERIAL COMPRESSION TO ACHIEVE HEMOSTASIS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT. THE RCFA AND THE ACCESS SITE WERE NOT CALCIFIED. A 6FR. SHEATH WAS USED DURING THE CLOSURE PROCEDURE. THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE 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 040356H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6 FR. OTHER: ANGIOMAX.