BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3222291 · Received July 12, 2013

    Report

    Report Number
    2024168-2013-04318
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 18, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT RETURNING FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE NOT RETURNED FOR ANALYSIS. SUBSEQUENTLY THE DEVICE WAS RETURNED. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE LINK WAS PULLED FROM THE POSTERIOR CUFF; THEREFORE, THE SUTURE WOULD NOT DEPLOY AND THE REPORTED EVENT WAS CONFIRMED. BASED ON THE REPORTED INFORMATION, MANUFACTURING INSPECTION CRITERIA AND ANALYSIS OF THE RETURNED DEVICE, PROBABLE CAUSE FOR THE REPORTED EVENT WAS DETERMINED TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED 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.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, USER FACILITY MEDWATCH NUMBER (B)(4) WAS RECEIVED WITH THE FOLLOWING ADDITIONAL INFORMATION: "EVENT DESC: SUTURES DID NOT DEPLOY. FAILED DEVICE REMOVED FROM STERILE FIELD." THE USER FACILITY REPORTER WAS CONTACTED AND NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE, AFTER A CARDIAC STENTING PROCEDURE. REPORTEDLY, THE SUTURES DID NOT DEPLOY. THE METHOD TO ACHIEVE HEMOSTASIS WAS NOT REPORTED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. AS THE NAME OF THE PHYSICIAN WAS NOT PROVIDED BY THE HOSPITAL, IT IS UNKNOWN IF THE PHYSICIAN HAS BEEN TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322957 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30108J1

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention