BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2192312 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05524
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 8, 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
    CO, 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 DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE OTHER PROGLIDE, IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT APPROXIMATELY 1 INCH OF MONOFILAMENT WAS EXPOSED AND THE REST OF THE MONOFILAMENT WAS STILL INSIDE THE DEVICE, THE NEEDLE TIP WAS NOT RETURNED. THE ANTERIOR CUFF WAS ENGAGED TO THE ANTERIOR NEEDLE TIP AND BOTH CUFFS WERE ATTACHED TO THE LINK. THERE WAS NO NEEDLE STRIKE MARK ON THE POSTERIOR FOOT. THE POSTERIOR CUFF WAS OUT OF THE POCKET AND THE POSTERIOR CUFF TABS WERE UNDISTURBED, INDICATING THAT A POSTERIOR CUFF MISS OCCURRED AND THIS WOULD RESULT IN A FAILURE TO RETRIEVE THE SUTURE DURING THE NEEDLE PLUNGER RETRACTION AND COULD APPEAR VERY SIMILAR TO THE REPORTED SUTURE BREAK. BECAUSE THE SUTURE COULD NOT BE RETRIEVED, THE KNOT WOULD NOT FORM TO ADVANCE TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL AS INTENDED. DURING THE INVESTIGATION, THE PLUNGER WAS REINSERTED TO TEST THE NEEDLE TRAJECTORY, NEEDLE DEPTH AND PUSH MANDREL TRAVEL AND THE RESULTS WERE ACCEPTABLE. THE MOST PROBABLE CAUSE FOR THE POSTERIOR CUFF MISS IS NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE BECAUSE OF A CHALLENGING ANATOMY OR FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45 DEGREE ANGLE THROUGHOUT DEPLOYMENT. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY RELEVANT NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT REVEAL ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. BASED ON THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED TWICE DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF A NON-CALCIFIED RIGHT COMMON FEMORAL ARTERY (RCFA) AFTER AN INTERVENTIONAL PROCEDURE USING A PROGLIDE DEVICE. REPORTEDLY, WHEN THE PLUNGER WAS RETRACTED FROM THE DEVICE BODY, A SUTURE BREAK OCCURRED. THE DEVICE WAS REMOVED AND A SECOND PROGLIDE WAS ATTEMPTED WITH THE SAME RESULT. THE DEVICE WAS REMOVED FROM THE PATIENT'S GROIN AND A 7FR. SHEATH WAS PLACED FOLLOWED BY MANUAL ARTERIAL COMPRESSION TO ACHIEVE HEMOSTASIS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT. A 6FR. SHEATH WAS USED DURING THE CLOSURE PROCEDURE. THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE 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 040356H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6 FR. OTHER: HEPARIN.