BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2191802 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05502
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. BEST GUESS OF PATIENTS WEIGHT. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE SHEATH WAS KINKED AT THE DISTAL END. THE DEVICE WAS IN THE PRE-PLUNGER DEPLOYMENT STATE WITH BLOOD PRESENT IN THE DEVICE BUT NOT AT THE MARKER PORT, INDICATING THAT THE MARKING HAD NOT BEEN ACHIEVED. THERE WAS NO OTHER DAMAGED DETECTED WITH DEVICE DURING TESTING, A PROXY GUIDE WIRE WAS INSERTED INTO THE PROXIMAL END OF THE SHEATH AND THE DEVICE TRACKED OVER THE GUIDE EXITING THE RAMP WITHOUT DIFFICULTY. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO AN INSPECTION DURING MANUFACTURING. SPECIFIC TO THIS CASE THE SHEATH, EXIT RAMP AND GUIDE WIRE PATENCY ARE INSPECTED TO ASSURE THEY ARE FREE OF KINKS, DAMAGE OR BLOCKAGE. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. A SHEATH KINK PREVENTING INSERTION CAN BE INFLUENCED BY, BUT NOT LIMITED TO: OPERATOR AGGRESSIVELY ADVANCING THE DEVICE, OBESE PATIENT, PANNICULUS NOT LIFTED, CHALLENGING ANATOMY (HEAVILY SCARRED, CALCIFIED TISSUE). IN THIS CASE THERE WAS NO CHALLENGING PATIENT ANATOMICAL CONDITION REPORTED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT. A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED. BASED ON THE INVESTIGATION FINDINGS, THE DIFFICULTY EXPERIENCED INSERTING THE DEVICE APPEARS TO BE MOST LIKELY RELATED TO THE OPERATIONAL INFLUENCES DURING USE. THERE WAS NO EVIDENCE OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN INSERTING THE DEVICE WHILE HOLDING PRESSURE, THE DISTAL GUIDE KINKED. THE DEVICE WAS REMOVED AND A SECOND PROGLIDE WAS USED TO ACHIEVE HEMOSTASIS. A 6FR SHEATH WAS USED DURING INSERTION OF THE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. 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 050366H

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention SHEATH: 6F