BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1923350 · Received December 13, 2010

    Report

    Report Number
    2953144-2010-03210
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 19, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. (B)(4): DURING PROCESSING OF THIS COMPLAINT ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FACILITY RETURNED 3 UNUSED/STERILE PROGLIDE DEVICES FROM LOT# 930396H FOR EVALUATION. THESE STERILE DEVICES WERE RETURNED FOR THE REPORTED COMPLAINT OF DIFFICULTY DEPLOYING THE PLUNGER, EXPERIENCED IN THE INCIDENT SUBMITTED FOR THIS MEDWATCH REPORT. ONE UNUSED/STERILE DEVICE WAS SELECTED FOR FUNCTIONAL TESTING. THE STERILE DEVICE WAS FUNCTIONALLY TESTED AND DEPLOYED IN A TORTUOUS PATH MODEL FIXTURE. THE DEVICE WAS DEPLOYED WITHOUT ANY ISSUES NOTED. BOTH CUFFS WERE CAPTURED AND THE SUTURE WAS SUCCESSFULLY RETRIEVED. THE DEVICE PERFORMED ACCORDING TO SPECIFICATION. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. NO NON-CONFORMING MATERIAL REPORT ISSUE WAS FOUND WRITTEN AGAINST THE REPORTED LOT NUMBER 930396H.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECHNICIAN 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 ENGAGE, WENT HALF WAY DOWN AND GOT STUCK. IT WOULD NOT ADVANCE FURTHER OR RETRACT. THE TECHNICIAN PARKED THE FOOT AND REMOVED THE DEVICE FROM THE PATIENT'S ANATOMY. ANOTHER PROGLIDE WAS USED TO ACHIEVE HEMOSTASIS. NO ADVERSE PATIENT EFFECT WAS REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 2 UNITS THAT WOULD NOT PRIME. PATIENT INJURY AND MEDICAL INTERVENTION WERE NOT REPORTED FOR THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    APPROXIMATELY 13 MONTHS POST PROCEDURE THE PATIENT UNDERWENT A SECOND PROCEDURE TO TREAT THE WORSENING OCCLUSION OF THE ANEURYSM. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT. NO OTHER 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-REDWOOD CITY 930396H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention