BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2191297 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05482
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE NOTED THE ANTERIOR CUFF WAS CAPTURED AND ATTACHED TO THE NEEDLE TIP. THE POSTERIOR CUFF HAD BEEN CAPTURED AND THEN DETACHED FROM THE NEEDLE TIP AS EVIDENCED BY DAMAGED CUFF TABS. THE CUFF DETACHMENT RESULTED IN THE REPORTED HEMORRHAGE. THE COMPLETE SUTURE WAS RETURNED PULLED OUT OF THE DEVICE. A NEEDLE TO CUFF DETACHMENT ALSO PREVENTS COMPLETION OF SUTURE DEPLOYMENT AND MAY HAVE THE SAME APPEARANCE AS THE REPORTED NEEDLE TO CUFF MISS. IN THE DEPLOYMENT SEQUENCE WHEN BOTH CUFFS ARE CAPTURED DURING NEEDLE DEPLOYMENT THE POSTERIOR NEEDLE TIP WITH RAIL END OF SUTURE ARE PULLED VIA THE LINK TO ANTERIOR CUFF ATTACHMENT THROUGH THE TISSUE AND INTO THE PREFORMED KNOT (NON-RAIL END OF SUTURE) CREATING THE LOOP. IN THIS CASE BECAUSE THE POSTERIOR CUFF DETACHED FROM THE NEEDLE TIP KNOT (LOOP) WAS NOT FORMED. DURING TESTING THE RETURNED PLUNGER WAS RE-INSERTED INTO THE DEVICE AND THE NEEDLE TRAJECTORY, DEPTH AND MANDREL TRAVEL WERE ACCEPTABLE. THE TEST RESULTS INDICATE THAT NEEDLE DEPLOYMENT WAS NOT A CONTRIBUTING FACTOR IN THE EXPERIENCE. THE NEEDLE TRAJECTORY OF EACH DEVICE IS INSPECTED TWICE DURING MANUFACTURING. THE ANALYSIS DID NOT INDICATE A PRODUCT QUALITY DEFICIENCY. A CUFF DETACHMENT CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO; MANUFACTURING, FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45 DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATING THE DEVICE AT ANY POINT DURING PLUNGER/NEEDLE DEPLOYMENT, DEPLOYMENT IN CHALLENGING ANATOMIES (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.), AGGRESSIVELY DEPLOYING OR REMOVING THE PLUNGER ARE AS FOLLOWS: EXCESSIVE FORCE DURING PLUNGER REMOVAL, JERKY MOTION OR A SIDE WALL STICK. PATIENT ANATOMICAL CONDITIONS CREATING UNINTENDED INTERACTION WITH HUMAN TISSUE, AGGRESSIVE AND FAST DEPLOYMENT OF THE PLUNGER. A REVIEW OF THE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. BASED ON THE INVESTIGATION OF THE RETURNED DEVICE ALTHOUGH A DEFINITIVE CAUSE COULD NOT BE DETERMINED THE CUFF DETACHMENT IN THIS CASE APPEARS TO BE RELATED TO THE OPERATIONAL INFLUENCES DURING USE AND NOT A PRODUCT QUALITY DEFICIENCY. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO AN INSPECTION DURING MANUFACTURING. IN ADDITION, 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 WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DIAGNOSTIC PERCUTANEOUS PERIPHERAL CATHERIZATION THROUGH A 6F PROCEDURAL SHEATH, ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, A NEEDLE-TO-CUFF MISS OCCURRED. WHEN THE NEEDLE PLUNGER WAS REMOVED FROM THE BODY OF THE DEVICE, THERE WAS NO SUTURE ATTACHED TO THE NEEDLE. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE 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 030126H

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention PROCEDURAL SHEATH 6F