BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2240313 · Received September 9, 2011

    Report

    Report Number
    2024168-2011-06223
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED PROGLIDE DEVICE REVEALED THAT THE NEEDLE PLUNGER REMAINED PARTIALLY INSIDE THE BODY OF THE DEVICE. DURING LAB TESTING, THE NEEDLE PLUNGER WAS REMOVED FROM THE DEVICE WITHOUT DIFFICULTY, SUGGESTING THERE WAS NO PROBLEM RETRACTING THE NEEDLE PLUNGER DURING USE. THE ANTERIOR AND POSTERIOR CUFFS WERE FOUND CAPTURING THEIR RESPECTIVE NEEDLES, AS DESIGNED. THE RAIL SUTURE WAS CUT AT APPROXIMATELY SEVEN INCHES DISTAL OF THE POSTERIOR NEEDLE. PART OF THE SUTURE CONTAINING THE SUTURE LOOP AND KNOT WERE NOT RETURNED WITH THE DEVICE, THEREFORE, IT COULD NOT BE DETERMINED IF THE KNOT WAS FORMED PROPERLY, IF THE SUTURE LOOP WAS APPROPRIATELY RELEASED FROM THE SUTURE BEARING AREA, IF THE DEVICE WAS DEPLOYED OUTSIDE THE ARTERY, OR WHEN THE SUTURE WAS CUT. IN ADDITION, THERE WAS NO INDICATION THAT THE SUTURE WAS CUT BY THE DEVICE DURING NEEDLE PLUNGER RETRACTION OR THE SUTURE RETRIEVAL PROCESS. BASED ON LIMITED, VAGUELY REPORTED INFORMATION, AND ANALYSIS OF THE RETURNED DEVICE, A PROBABLE CAUSE FOR VAGUELY REPORTED PRODUCT EXPERIENCE COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. EVERY SUTURE IS INSPECTED FOR PROPER ASSEMBLY DURING MANUFACTURING. 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 HAS BEEN RETURNED FOR EVALUATION. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN INTERVENTIONAL PROCEDURE, ARTERIOTOMY CLOSURE WAS ATTEMPTED OF THE COMMON FEMORAL ARTERY USING A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, WHEN THE OPERATOR REMOVED THE NEEDLE PLUNGER HE BELIEVED THAT IT DID NOT APPEAR NORMAL AND DECIDED TO REMOVE THE DEVICE AND USE A NON-ABBOTT DEVICE TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THE PHYSICIAN WAS REPORTED TO BE IN TRAINING 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 050096H

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention PROCEDURAL SHEATH 6F