BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2250464 · Received September 15, 2011

    Report

    Report Number
    2024168-2011-06340
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    July 27, 2011
    Report Date
    August 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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: EVALUATION OF THE RETURNED PROGLIDE DEVICE REVEALED THAT ALTHOUGH A NEEDLE-TO-CUFF MISS WAS REPORTED; NEEDLE DEPLOYMENT AND SUTURE RETRIEVAL WERE SUCCESSFUL AS INDICATED BY THE ANTERIOR AND POSTERIOR NEEDLES BEING CAPTURED BY THEIR SUBSEQUENT CUFFS. ADDITIONALLY, APPROXIMATELY ONE AND A HALF INCHES OF THE RAIL SUTURE THAT REMAINED ATTACHED TO THE NEEDLE PLUNGER, WAS CUT. A NEEDLE-TO-CUFF MISS MAY BE DUE TO A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO OPERATOR DEPLOYMENT TECHNIQUE, MANUFACTURING, OR PATIENT ANATOMICAL CONDITIONS. THE DEPLOYMENT TECHNIQUE OF THE OPERATOR, SUCH AS, A FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45-DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATING THE DEVICE AT ANY POINT DURING NEEDLE PLUNGER DEPLOYMENT, AGGRESSIVELY DEPLOYING OR REMOVING THE NEEDLE PLUNGER AND/OR INADEQUATE POSITIONING OF THE FOOT AGAINST THE ARTERIAL WALL MAY CAUSE A NEEDLE-TO-CUFF MISS. HOWEVER, NO INFORMATION WAS PROVIDED REGARDING THE DEPLOYMENT TECHNIQUE OF THE OPERATOR. THE OPERATOR WAS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. DURING MANUFACTURING, THE NEEDLE TRAJECTORY OF EVERY DEVICE IS VERIFIED TWICE. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PRODUCT QUALITY, TO INCLUDE SUTURE PLACEMENT, TO VERIFY THE FUNCTIONALITY OF THE DEVICE. PATIENT ANATOMY MAY CONTRIBUTE TO A NEEDLE-TO-CUFF MISS. A FEMORAL ANGIOGRAM PERFORMED PRIOR TO ARTERIOTOMY CLOSURE REVEALED NO VESSEL CALCIFICATION, VESSEL TORTUOSITY, OR SCARRING AT THE ACCESS/GROIN SITE. BASED ON THE RETURN DEVICE INVESTIGATION, THE REPORTED PRODUCT EXPERIENCE THAT OCCURRED DURING SUTURE/NEEDLE DEPLOYMENT COULD NOT BE CONFIRMED, AND A DEFINITIVE CAUSE COULD NOT BE IDENTIFIED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON CONFORMING MATERIAL REPORT ASSOCIATED WITH THIS LOT. A REVIEW OF THE COMPLAINT HANDLING DATABASE FOR LOT DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FOR CONTINUED BLEEDING. A PRODUCT QUALITY DEFICIENCY WAS NOT NOTED. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO AN INSPECTION DURING MANUFACTURING. A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: DURING NEEDLE DEPLOYMENT, THE NEEDLES DID NOT CROSS THE VESSEL WALL; THEREFORE, THE NEEDLES DID NOT CONNECT TO THE CUFFS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN INTERVENTIONAL CAROTID PROCEDURE, ARTERIOTOMY CLOSURE OF THE FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, AN UNKNOWN PROBLEM OCCURRED, WHICH REQUIRED THE USE OF A SECOND PROGLIDE DEVICE TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 940266H

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention