BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2231521 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06079
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE PLUNGER, SUTURE, LINK, NEEDLES, AND CUFFS WERE NOT RETURNED WITH THE DEVICE. THE SCOPE OF THIS INVESTIGATION WAS VERY LIMITED AND THE REPORTED NEEDLE-TO-CUFF MISS COULD NOT BE CONFIRMED. 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 STRIKING THE FOOT INSTEAD OF ENGAGING WITH THE CUFF INSIDE THE FOOT POCKET DURING NEEDLE DEPLOYMENT. THERE WERE NO ABNORMAL OBSERVATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED NEEDLE-TO-CUFF MISS. POSSIBLE CONTRIBUTING FACTORS FOR REPORTED CUFF MISS INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, CHALLENGING ANATOMICAL CONDITIONS, AND INCORRECT DEPLOYMENT TECHNIQUES. DUE TO ALL RELATED COMPONENTS NOT BEING RETURNED WITH THE DEVICE FOR INVESTIGATION, NO MANUFACTURING-RELATED DEFICIENCIES COULD BE IDENTIFIED; HOWEVER, THE NEEDLE TRAJECTORY OF EVERY DEVICE IS VERIFIED TWICE DURING MANUFACTURING. DURING LAB TESTING, A PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL AND THE RESULTS MET THE MANUFACTURING CRITERIA. THERE WERE NO CHALLENGING ANATOMICAL CONDITIONS REPORTED, WHICH COULD HAVE CONTRIBUTED TO THE REPORTED CUFF MISS. THERE WAS NO INFORMATION REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE TO SUGGEST THAT THE DEVICE MIGHT HAVE BEEN TWISTED AND/OR ROTATED DURING NEEDLE DEPLOYMENT OR THE NEEDLES WERE DEPLOYED WHEN THE DEVICE WAS NOT AT APPROXIMATE 45 DEGREE ANGLE, WHICH COULD HAVE CONTRIBUTED TO THE REPORTED CUFF MISS. BASED ON THE REPORTED INFORMATION, THE MANUFACTURING INSPECTION CRITERIA, AND ANALYSIS OF THE RETURNED DEVICE, THE PROBABLE CAUSE FOR THE REPORTED CUFF MISS COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THIS LOT REVEALED NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION INDICATES THAT THE ATTEMPTED ARTERIOTOMY CLOSURE OCCURED IN THE RIGHT FEMORAL ARTERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL USING A PROGLIDE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. THE DEVICE WAS REMOVED AND HEMOSTASIS WAS ACHIEVED USING A SECOND PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. 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 010236H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEPARIN| SHEATH: 7F