BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2191676 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05491
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE NOTED THAT THE LINK WAS PULLED AT THE SWAGE END OF THE POSTERIOR CUFF WHILE RETRACTING THE NEEDLE PLUNGER WHICH SUBSEQUENTLY RESULTED IN A FAILURE TO RETRIEVE THE SUTURE AND COULD APPEAR VERY SIMILAR TO THE REPORTED CUFF MISS. A LINK PULL SUGGESTED THAT THERE WAS RESISTANCE ENCOUNTERED WHILE RETRACTING THE NEEDLE PLUNGER TO RETRIEVE THE SUTURE. CONTRIBUTING FACTORS FOR THE LINK BREAK DURING THE SUTURE RETRIEVAL PROCESS INCLUDED, BUT NOT LIMITED TO, MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS, AND INCORRECT DEPLOYMENT TECHNIQUES. THE SUTURE WAS RETURNED INTACT AND THERE WAS NO INDICATION THAT IT WAS DRAGGED THROUGH THE DEVICE WHILE RETRACTING THE NEEDLE PLUNGER WHICH COULD HAVE CONTRIBUTED TO THE LINK PULL. ALSO, THERE WERE NO DAMAGES OBSERVED AT THE SUTURE BEARING TO SUGGEST THAT THE SUTURE OR LINK WAS DRAGGED THROUGH THE SUTURE BEARING. ADDITIONALLY, DURING LAB TESTING, THE PROXY PLUNGER WAS INSERTED AND RETRACTED SUCCESSFULLY WITHOUT ANY OBSERVABLE RESISTANCE. THERE WERE NO REPORTED CHALLENGING ANATOMICAL CONDITIONS WHICH COULD HAVE CONTRIBUTED TO THE LINK PULL. ALSO, THERE WAS NO INFORMATION REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE TO SUGGEST INCORRECT TECHNIQUE. THERE WAS NO INDICATION THAT THE NEEDLE PLUNGER WAS ABRUPTLY PULLED OUT OF THE DEVICE AFTER NEEDLE DEPLOYMENT WHICH COULD CAUSE THE LINK TO BE PULLED FROM THE POSTERIOR CUFF. A REVIEW OF THE FINISHED GOOD LOT HISTORY RECORD WAS PERFORMED AND DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT AND ITS INVESTIGATION. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. BASED ON THE REPORTED INFORMATION, THE INVESTIGATION FINDINGS, AND WITHOUT THE PLUNGER, LINK, ANTERIOR CUFF, AND ANTERIOR NEEDLE NOT BEING RETURNED WITH THE DEVICE, WHICH LIMITED THE SCOPE OF THIS INVESTIGATION, THE PROBABLE CAUSE FOR THE LINK PULL FROM THE SWAGE END OF THE POSTERIOR CUFF COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED.

    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 WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERVENTIONAL CORONARY STENTING PROCEDURE THROUGH A 5F SIZED SHEATH, ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, A NEEDLE-TO-CUFF MISS OCCURRED. WHEN THE NEEDLE PLUNGER WAS REMOVED FROM THE BODY OF THE DEVICE, NO SUTURE WAS PRESENT ON THE NEEDLE. THE DEVICE WAS REMOVED AND MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. THE OPERATOR WAS REPORTED TO BE 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 960256H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROCEDURAL SHEATH 5F