BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2032842 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02119
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 4, 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
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. ESTIMATED AGE OF THE PATIENT WHO WAS REPORTED AS APPROXIMATELY (B)(6) OLD. ESTIMATED WEIGHT OF THE PATIENT WHO WAS REPORTED AS APPROXIMATELY (B)(6). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. A SUTURE BREAK CAN BE CAUSED BY A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO, TOO MUCH TENSION APPLIED, OR THE SUTURE WAS NICKED. ULTIMATELY, THE RETURN OF PROGLIDE DEVICE MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE EXPERIENCED SUTURE BREAK. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, A SAMPLING OF SUTURES ARE TESTED UNDER STRESS FOR DIAMETER MEASUREMENTS BEFORE RELEASE TO MANUFACTURING. A SAMPLING OF FINISHED DEVICES IS ALSO TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT AND WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED EXPERIENCE CANNOT BE DETERMINED. HOWEVER, THE REPORTED HEAVY SCAR TISSUE IN THE ARTERY MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEALED ANY NONCONFORMING MATERIAL RECORDS RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE ATTEMPTED ARTERIOTOMY CLOSURE OF A HEAVILY SCARRED COMMON FEMORAL ARTERY AFTER A HEART CATHETERIZATION. REPORTEDLY, AS THE PLUNGER WAS REMOVED, THE SUTURE BROKE. THE PROCEDURAL SHEATH WAS RE-INSERTED AND ONCE THE PATIENT WAS IN RECOVERY, MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 950356H

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention