BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE¿

    MDR report key: 19568244 · Received June 19, 2024

    Report

    Report Number
    2024168-2024-07392
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    March 22, 2024
    Report Date
    October 11, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648113154
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED MECHANICAL JAM PLUNGER WAS NOT CONFIRMED. HOWEVER, NEEDLE TO CUFF MISS WAS OBSERVED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THE REPORTED DIFFICULTY AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO A NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH PATIENT ANATOMY (HUMAN TISSUE, ETC.) OR FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT DUE TO THE CIRCUMSTANCE OF THE PROCEDURE. THE REPORTED, 'IT DID NOT LOCK' IS A CONFIRMATION THE NEEDLE AND CUFF DID NOT ENGAGE RESULTING IN THE SUTURE RETRIEVAL ISSUE NEEDLE TO CUFF MISS. 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 INFORMATION: D4 MODEL # ADDED. CORRECTIONS: D1 BRAND NAME UPDATED. D2A COMMON DEVICE NAME UPDATED. D3 NAME UPDATED. D3 ADDRESS, CITY, POSTAL CODE UPDATED. D4 LOT NUMBER UPDATED FROM 3062141 TO 3061941. E1 CONTACT UPDATED (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A VESSEL CLOSURE OF AN UNKNOWN VESSEL USING A RELATIVE TO AN UNSPECIFIED PROCEDURE. REPORTEDLY, WHEN STEP #2 WAS PRESSED, IT DID NOT LOCK. THE DEVICE FAILED. ANOTHER PROGLIDE DEVICE WAS REPORTED. AN UNSPECIFIED METHOD WAS USED TO ACHIEVE HEMOSTASIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595262 PERCLOSE PROGLIDE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673-05 3061941 08717648113154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention