BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2160202 · Received July 13, 2011

    Report

    Report Number
    2024168-2011-04947
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 17, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE DEVICE HAS NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. CONTINUED BLEEDING FOLLOWING DEVICE DEPLOYMENT MAY BE DUE TO A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO: USER TECHNIQUE, OPERATIONAL CONTEXT, ANATOMICAL CONDITION, OR A MANUFACTURING ANOMALY. TO HELP ENSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATION THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. AS FOR OTHER FACTORS, THE INFORMATION PROVIDED BY THE CUSTOMER IS LIMITED AND DOES NOT ALLOW FOR ASSIGNING A PROBABLE CAUSE TO THE EXPERIENCED EVENT. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, THE LOT HISTORY RECORD WAS NOT REVIEWED AND A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS NOT PERFORMED. BASED ON THE INFORMATION AVAILABLE AND MANUFACTURING INSPECTION CRITERIA, THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF A HEAVILY CALCIFIED COMMON FEMORAL ARTERY (CFA) AFTER AN INTERVENTIONAL PROCEDURE USING A PROGLIDE DEVICE. REPORTEDLY, A CUFF MISS OCCURRED AND THE DEVICE WAS REMOVED FROM THE PATIENT'S ANATOMY. A SECOND PROGLIDE DEVICE WAS ATTEMPTED,AFTER COMPLETING DEVICE DEPLOYMENT BLEEDING WAS STILL OBSERVED. MANUAL ARTERIAL COMPRESSION WAS APPLIED FOR 10 MINUTES TO ACHIEVE HEMOSTASIS. THE FACILITY REPORTER WAS UNABLE TO DETERMINE IF THE BLEEDING WAS ARTERIAL OR TISSUE TRACT SEEPING. THE ACCESS SITE WAS ALSO DESCRIBED AS CALCIFIED, BUT IT WAS NOT INDICATED THE DEGREE OF CALCIFICATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT. THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE. A 6FR SHEATH WAS USED WITH THE CLOSURE 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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention SHEATH: 6FR. OTHER: ANGIOMAX.