BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2061172 · Received April 18, 2011

    Report

    Report Number
    2024168-2011-02695
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 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
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND IT WAS PARTIALLY DEPLOYED. THE PLUNGER WITH ANTERIOR NEEDLE TIP AND CUFF WERE NOT RETURNED. THE CUFF BASE ON THE DETACHMENT IS MOST LIKELY ATTACHED TO THE ANTERIOR NEEDLE TIP. THE SUTURE WAS PARTIALLY LOADED IN THE DEVICE. THE POSTERIOR CUFF WITH LINK WAS STILL IN THE FOOT POCKET AND ITS CUFF TABS WERE UNDISTURBED, THE LINK HAD BROKEN OFF AT THE ANTERIOR CUFF. BASED ON THE INVESTIGATION FINDINGS, THE CAUSE FOR THE DIFFICULTY DEPLOYING THE PLUNGER COULD NOT BE DETERMINED. HOWEVER, DURING THE DEPLOYMENT SEQUENCE WHEN STEP #2 (PLUNGER DEPLOYMENT) IS PREFORMED BEFORE STEP #1 (RAISING THE LEVER) THE PLUNGER DEPLOYMENT WOULD BE DIFFICULT AND THE SAME CONDITIONS DETECTED DURING THIS INVESTIGATION MAY BE PRESENT. BASED ON THE INVESTIGATION FINDINGS, A POSTERIOR CUFF MISS OCCURRED AS EVIDENCED BY THE POSTERIOR CUFF REMAINING IN THE FOOT POCKET; THEREFORE, THE REPORTED EVENT IS CONFIRMED. BECAUSE THE NEEDLE TIP DID NOT ENGAGE THE POSTERIOR CUFF, THE CUFF WAS NOT EJECTED FROM THE FOOT. WHEN THE PLUNGER WAS REMOVED FROM THE DEVICE, THE LINK WAS HELD ON ONE END BY THE POSTERIOR CUFF IN THE FOOT POCKET WHILE BEING PULLED ON THE OTHER END BY THE WITHDRAWAL OF THE PLUNGER, THIS RESULTED IN THE ANTERIOR CUFF DETACHING FROM THE NEEDLE. A PROXY PLUNGER WAS INSERTED INTO THE DEVICE TO TEST NEEDLE TRAJECTORY AND THE RESULTS WERE ACCEPTABLE. THE POSTERIOR FOOT WAS EXAMINED AND NO NEEDLE STRIKE MARKS WERE DETECTED, INDICATING THE POSTERIOR NEEDLE WAS DEFLECTED OUTSIDE OF THE FOOT POCKET DURING DEPLOYMENT. A CUFF-MISS 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 AND/OR INADEQUATE POSITIONING OF THE FOOT AGAINST THE ARTERIAL WALL. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. BASED ON THE INVESTIGATION FINDINGS, THE POSTERIOR CUFF MISS EXPERIENCED DURING THE PROCEDURE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PRODUCT. THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY PROBLEM. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER PREVIOUS INCIDENTS REPORTED FOR FAILURE TO DEPLOY PLUNGER FOR THIS LOT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE PLUNGER WOULD NOT GO DOWN COMPLETELY INTO THE DEVICE AND A CUFF MISS OCCURRED. A SECOND PROGLIDE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 020036H

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention