BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 13026054 · Received December 17, 2021

    Report

    Report Number
    2024168-2021-11762
    Event Type
    Injury
    Date Received
    December 17, 2021
    Date of Event
    December 10, 2021
    Report Date
    March 1, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. ANALYSIS OF THE RETURNED DEVICE FOUND A NEEDLE TIP SEPARATION. THE DETACHED NEEDLE TIP WAS NOT RETURNED WITH THE DEVICE. ADDITIONALLY, THE FOOT OF THIS DEVICE WAS SEPARATED AND NOT RETURNED. THE ACCOUNT CONFIRMED THE FOOT SEPARATION OCCURRED OUTSIDE THE PATIENT AS A RESULT OF INTENTIONAL MANIPULATION OF THE DEVICE. THE CUFF MISS WAS NOT CONFIRMED DUE TO THE CONDITION OF THE DEVICE. A REVIEW OF THE MANUFACTURING RECORDS IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED DIFFICULTY AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY OR INABILITY TO MAINTAIN POSITION/STABILITY OF THE DEVICE DURING DEPLOYMENT DUE TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL TWO PROSTYLE DEVICES REFERENCED ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED: PER RETURN ANALYSIS, THE FOOT OF ONE OF THE DEVICES (CN-091579) WAS SEPARATED. THE ACCOUNT CONFIRMED THE FOOT SEPARATION WAS AS A RESULT OF INTENTIONAL MANIPULATION OF THE DEVICE OUTSIDE THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THIS WAS AN ARTERIOTOMY CLOSURE OF A CALCIFIED RIGHT COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH HOLE PRIOR TO AN IMPELLA HEART PUMP INTERVENTIONAL PROCEDURE. THE SUTURE OF ONE PROSTYLE WAS SUCCESSFULLY PRE-PLACED. REPORTEDLY, A CUFF MISS OCCURRED WITH THE NEXT THREE PROSTYLE DEVICES AND NO ADDITIONAL DEVICE WAS ATTEMPTED. THE SHEATH WAS UPSIZED TO 16F TO CONTINUE THE IMPELLA PROCEDURE; HOWEVER, THE PATIENT DIED DURING THE PROCEDURE. IN THE PHYSICIAN¿S OPINION, THE DEATH WAS DUE TO THE PATIENT¿S DISEASE AND NOT RELATED TO THE PROSTYLE CLOSURE DEVICES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1922619 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 1080942

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention HEPARIN| VESSEL CLOSURE: PROSTYLE