BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1954534 · Received January 10, 2011

    Report

    Report Number
    2024168-2011-00181
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 2, 2010
    Report Date
    December 16, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE DEVICE RECEIVED FOUND THAT ALTHOUGH IT WAS REPORTED THAT THE SUTURE BROKE DURING KNOT ADVANCEMENT TO THE ARTERIOTOMY, EVALUATION FOUND THAT THE CONDITION WAS SUCH THAT THE SUTURE COULD NOT HAVE BEEN RETRIEVED UNDER NORMAL DEVICE DEPLOYMENT WHILE WITHIN THE ANATOMY. THE DEVICE WAS RETURNED WITHOUT THE NEEDLE PLUNGER, POSTERIOR NEEDLE, SUTURE, AND ANTERIOR CUFF, WHICH LIMITED THE SCOPE OF THE INVESTIGATION. THE LINK MATERIAL HAD BEEN DETACHED FROM THE SWAGE END OF THE ANTERIOR CUFF, BUT REMAINED ATTACHED TO THE POSTERIOR CUFF, WHICH REMAINED LOADED IN THE POSTERIOR FOOT POCKET. THE DETACHED LINK FROM THE ANTERIOR CUFF IS A DIRECT RESULT OF THE POSTERIOR NEEDLE-TO-CUFF MISS DUE TO HIGH STRESS ENCOUNTERED OVERCOMING THE ANTERIOR CUFF AND LINK UNION DURING NEEDLE PLUNGER WITHDRAWAL FROM THE DEVICE. A PROXY NEEDLE PLUNGER WAS INSERTED INTO THE BODY OF THE DEVICE RESULTING IN BOTH NEEDLES ENTERING THEIR RESPECTIVE FOOT POCKET, THE POSTERIOR NEEDLE AND PUSH MANDREL EJECTED THE POSTERIOR CUFF FROM THE POSTERIOR FOOT POCKET, INDICATING PROPER NEEDLE TRAJECTORY. A WHITE, HARD, ROCK-LIKE MATERIAL, CONSISTENT WITH CALCIFIED MATERIAL WAS IMPACTED WITHIN THE POSTERIOR FOOT POCKET, WHICH LED TO A POSTERIOR NEEDLE-TO-CUFF MISS; HOWEVER, THERE WAS NO DETECTED FOOT DAMAGED TO INDICATE A NEEDLE STRIKE. THE PROGLIDE DEVICE INSTRUCTIONS FOR USE, UNDER SPECIAL PATIENT POPULATIONS STATE THE SAFETY AND EFFECTIVENESS OF THE DEVICE HAS NOT BEEN ESTABLISHED IN PATIENT POPULATIONS WITH FEMORAL ARTERY CALCIUM, WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. BASED ON THE FINDINGS, THE ROOT CAUSE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. THE ANATOMICAL ISSUE OF CALCIFIED MATERIAL WITHIN THE ARTERY PREVENTING THE ENGAGEMENT OF THE POSTERIOR NEEDLE AND POSTERIOR CUFF AND CUFF EJECTION FROM THE POSTERIOR FOOT, WHICH ALSO RESULTED IN THE LINK TO ANTERIOR CUFF DETACHMENT. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AS THE KNOT WAS ADVANCED TO THE ARTERIAL SURFACE, THE SUTURE BROKE. THE SUTURE WAS REMOVED AND A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 930396H

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention