BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2040250 · Received April 5, 2011

    Report

    Report Number
    2024168-2011-02380
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 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
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THE BODY COMPONENTS OF THE DEVICE; HANDLE TO FOOT FUNCTION, GUIDE TUBE, NEEDLE GUIDE, BRIDGE, SUTURE BEARING, EXIT RAMP AND SHEATH WERE NORMAL; THERE WAS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY THAT WOULD HAVE CONTRIBUTED TO THE REPORTED FAILURE TO DEPLOY THE SUTURE. THE POSTERIOR CUFF WAS STILL LOADED ON THE FOOT. BOTH CUFFS WERE ATTACHED TO THE LINK AND THE ANTERIOR CUFF TABS WERE DAMAGED. BASED ON THE EVIDENCE FOUND ON THE RETURNED DEVICE, THE POSTERIOR CUFF WAS MISSED AND THE ANTERIOR CUFF DETACHED FROM THE NEEDLE TIP WHICH WAS A DIRECT RESULT OF THE POSTERIOR CUFF MISS. BECAUSE THE NEEDLE 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. DURING THE INVESTIGATION, THE PLUNGER WAS REINSERTED. THE NEEDLE TRAJECTORY, NEEDLE DEPTH AND PUSH MANDREL TRAVEL WERE ACCEPTABLE. BECAUSE LAB TESTING OF THE DEVICE RESULTED IN ACCEPTABLE NEEDLE TRAJECTORY, THE MOST PROBABLE CAUSE FOR THE POSTERIOR CUFF MISS IS NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE DURING NEEDLE DEPLOYMENT. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A DEFINITIVE CAUSE COULD NOT BE DETERMINED AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE PROGLIDE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY AFTER AN ENDOLUMINAL ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR. REPORTEDLY, THE PROGLIDE WAS BEING USED IN A PRE-CLOSURE FASHION WHEN IT FAILED TO DEPLOY THE SUTURE. THE DEVICE WAS REMOVED FROM THE PATIENT'S ANATOMY AND A SECOND PROGLIDE WAS SUCCESSFULLY USED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. 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 940266H

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention