BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2033043 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02149
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 4, 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 OF THE RETURNED DEVICE INDICATED THAT NEEDLE DEPLOYMENT WAS SUCCESSFUL AS BOTH CUFFS CAPTURED THE NEEDLES. THE KNOT WAS PROPERLY FORMED AND THE RAIL SUTURE END WAS CUT WITH THE DEVICE CUTTER. THIS IS INDICATIVE OF SUCCESSFUL SUTURE RETRIEVAL DURING THE NEEDLE PLUNGER RETRACTION; HOWEVER, THE SUTURE KNOT AND LOOP DID NOT HAVE ANY TISSUE CAPTURED. THIS OBSERVATION IS CONSISTENT WITH THE SUTURE BEING PULLED OUT OF THE ARTERY WHILE ADVANCING THE KNOT TO THE ARTERIAL SURFACE DUE TO INSUFFICIENT TISSUE CAPTURED OR THE DEVICE MIGHT HAVE BEEN DEPLOYED OUTSIDE THE ARTERY. BASED ON THE INVESTIGATION FINDINGS, NEEDLE DEPLOYMENT AND SUTURE RETRIEVAL WERE ALL SUCCESSFUL AS DESIGNED; HOWEVER, THE SUTURE KNOT COULD NOT BE COMPLETELY DELIVERED TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL AND THE PROBABLE CAUSE IS RELATED TO THE OPERATIONAL CONTEXT IN THE USE OF THE DEVICE. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT DATABASE REVEALED NO SIMILAR INCIDENTS 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. (B)(6). 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 TECHNICIAN, TRAINED IN THE USE OF THE PROGLIDE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. DURING DEPLOYMENT HE NOTICED A LOT OF PLAY IN THE FOOTPLATE. HE REMOVED THE DEVICE AND APPLIED MANUAL COMPRESSION TO ACHIEVE HEMOSTASIS. THERE WERE NO 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 010166H

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention