BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2220832 · Received August 23, 2011

    Report

    Report Number
    2024168-2011-05911
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 29, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE WHOLE MONOFILAMENT SUTURE WAS RETURNED LOOSE WITH THE POSTERIOR CUFF AND POSTERIOR NEEDLE TIP REMAINING ATTACHED TO THE RAIL END. BASED ON THE INVESTIGATION FINDINGS, THE LINK WAS PULLED FROM THE SWAGE-END OF THE POSTERIOR CUFF. THE LINK CONNECTS THE ANTERIOR NEEDLE TO THE SUTURE; IF THE LINK IS PULLED FROM THE CUFF, THE SUTURE WILL NOT BE PRESENT DURING NEEDLE PLUNGER WITHDRAWAL AND CAN APPEAR VERY SIMILAR TO A NEEDLE-TO-CUFF MISS. SINCE THE SUTURE COULD NOT BE RETRIEVED, THE KNOT WOULD NOT BE FORMED TO BE ADVANCED TO THE ARTERIAL SURFACE TO ACHIEVE HEMOSTASIS. THIS WOULD RESULT IN CONTINUED BLEEDING THAT WOULD REQUIRE AN ALTERNATIVE METHOD TO ACHIEVE HEMOSTASIS SUCH AS MANUAL COMPRESSION THAT WAS APPLIED IN THIS CASE. THE LINK BEING PULLED FROM THE SWAGE-END OF A CUFF CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO MANUFACTURING, EXCESSIVE TENSION DURING NEEDLE PLUNGER RETRACTION BY AGGRESSIVELY REMOVING THE NEEDLE PLUNGER AND USE OF EXCESSIVE FORCE CAN BE CAUSED BY HIGH FRICTION AGAINST THE SUTURE DUE TO CHALLENGING ANATOMIES. A SEARCH OF THE LOT HISTORY RECORD FOR THE REPORTED COMPLAINT DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EXPERIENCE. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO AN INSPECTION DURING MANUFACTURING AND A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DIAGNOSTIC PERCUTANEOUS CATHETERIZATION, ARTERIOTOMY CLOSURE WAS ATTEMPTED OF THE COMMON FEMORAL ARTERY WITH A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, A NEEDLE-TO-CUFF MISS OCCURRED. WHEN THE NEEDLE PLUNGER WAS REMOVED, NO SUTURE WAS ATTACHED TO THE NEEDLE. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. 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 060156H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention