BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2192207 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05516
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 11, 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
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, WHICH MAY HAVE ASSISTED IN THE INVESTIGATION. THEREFORE, IT IS NOT POSSIBLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED SUTURE NOT PRESENT DURING PLUNGER RETRACTION. A CUFF MISS CAN BE INFLUENCED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO: MANUFACTURING, 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; AND PATIENT ANATOMY (E.G. HEAVILY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.). INFORMATION CONCERNING USER TECHNIQUE AND PATIENT RELEVANT ANATOMICAL INFORMATION WAS NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY RELEVANT NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND A QUERY OF THE COMPLAINT HANDLING DATABASE INDICATE NO INDICATION OF A LOT SPECIFIC QUALITY DEFICIENCY. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED TWICE DURING MANUFACTURING. SAMPLINGS OF UNITS ARE DESTRUCTIVELY TESTED TO VERIFY PRODUCT QUALITY, INCLUDING SUTURE PLACEMENT.

    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 REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE USING A PROGLIDE DEVICE. REPORTEDLY, THE PLUNGER WAS RETRACTED FROM THE DEVICE BODY AND THE SUTURE WAS NOT PRESENT. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. 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 030176H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention