BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2143287 · Received June 28, 2011

    Report

    Report Number
    2024168-2011-04541
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4) EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND THAT THE PLUNGER, SUTURE, LINK, NEEDLES, AND CUFFS WERE NOT RETURNED LIMITING THE SCOPE OF THIS INVESTIGATION. INSPECTION OF THE DEVICE REVEALED NO ABNORMAL OBSERVATIONS. POSSIBLE CONTRIBUTING FACTORS FOR THE REPORTED PRODUCT EXPERIENCE INCLUDE, BUT IS NOT LIMITED TO, MANUFACTURING, ANATOMICAL CONDITIONS, AND/OR DEPLOYMENT TECHNIQUE. THERE WAS NO NEEDLE STRIKE MARK AT THE POSTERIOR FOOT TO SUGGEST THAT THE POSTERIOR CUFF MISS MIGHT HAVE OCCURRED DUE TO THE POSTERIOR NEEDLE INTERACTING WITH ARTERIAL CALCIFICATION AND STRIKING THE FOOT INSTEAD OF ENGAGING WITH THE CUFF INSIDE THE FOOT POCKET DURING NEEDLE DEPLOYMENT. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED DURING MANUFACTURING. DURING TESTING, A PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL AND THE RESULTS MET THE MANUFACTURING CRITERIA. THERE WAS NO INFORMATION REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE THAT SUGGESTED INCORRECT TECHNIQUE. THE REPORTED ARTERIAL CALCIFICATION COULD CONTRIBUTE TO THE PRODUCT EXPERIENCE; HOWEVER, THIS COULD NOT BE CONFIRMED. BASED ON THE INVESTIGATION FINDINGS, THE REPORTED PRODUCT EXPERIENCE COULD NOT BE CONFIRMED AND A CAUSE RELATED TO THE DEVICE COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY DEFICIENCIES WERE DETECTED. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS RELEVANT TO THIS REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF THE CALCIFIED RIGHT COMMON FEMORAL ARTERY USING A PERCLOSE PROGLIDE WAS ATTEMPTED AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER DEPLOYMENT, THE SUTURES DID NOT TAKE. THE KNOT WAS DESCRIBED AS LOOSE. A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. REPORTEDLY, THE PHYSICIAN IS PROFICIENT IN THE USE OF THE 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 040106H

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention