BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2131169 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04242
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION, WHICH MAY HAVE AIDED IN THE INVESTIGATION. NO SUTURE ATTACHED CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO: MANUFACTURING, HOWEVER, TO ENSURE THIS TYPE OF EXPERIENCE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED DURING MANUFACTURE OF THE DEVICE. IN ADDITION, A SAMPLING OF FINISHED DEVICES IS ALSO DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. ANOTHER CONTRIBUTING FACTOR IS USER TECHNIQUE, SUCH AS, FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45-DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATING THE DEVICE AT ANY POINT DURING PLUNGER/NEEDLE DEPLOYMENT, AGGRESSIVELY DEPLOYING OR REMOVING THE PLUNGER AND/OR INADEQUATE POSITIONING OF THE FOOT AGAINST THE ARTERIAL WALL. AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORT OF NO SUTURES ATTACHED TO THE NEEDLES. PATIENT ANATOMY (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.) CAN CAUSE THE REPORTED EVENT. WHETHER THESE CONDITIONS PLAYED A ROLE IN THE EXPERIENCED EVENT COULD NOT BE VERIFIED. IN THIS CASE NO INFORMATION CONCERNING PATIENT ANATOMICAL CONDITION AND USER TECHNIQUE WAS PROVIDED AND BASED ON THE INSPECTION CRITERIA AND THE AVAILABLE INFORMATION, NO PRODUCT QUALITY DEFICIENCY WAS NOTED. BASED ON THE AVAILABLE INFORMATION AND THE DEVICE INSPECTION CRITERIA, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE COMPLAINT HANDLING DATABASE WAS NOT PERFORMED BECAUSE THE DEVICE LOT NUMBER WAS NOT REPORTED AND THE DEVICE WAS NOT RETURNED.

    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 INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER THE DEVICE WAS DEPLOYED AND THE PLUNGER WAS REMOVED NO SUTURES WERE ATTACHED TO THE NEEDLES. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6 F