BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 20727416 · Received November 19, 2024

    Report

    Report Number
    2024168-2024-13677
    Event Type
    Injury
    Date Received
    November 19, 2024
    Date of Event
    November 4, 2024
    Report Date
    December 21, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED. ANALYSIS WILL NOT BE REQUIRED AS ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WAS NO DEVICE MALFUNCTION OR ADVERSE EVENT ASSOCIATED WITH THIS DEVICE. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. D9 - DEVICE AVAILABLE FOR EVALUATION UPDATED FROM YES TO NO. H6 - HEALTH EFFECT - IMPACT CODE 4641 WAS REMOVED AND REPLACED WITH CODE 2199; MEDICAL DEVICE PROBLEM CODE 3190 WAS REMOVED AND REPLACED WITH CODE 3189.

    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 DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A VESSEL PUNCTURE CLOSURE OF AN UNKNOWN VESSEL USING A PROSTYLE DEVICE. REPORTEDLY, AN ABNORMALITY WAS OBSERVED ON SEVERAL PROSTYLES FROM THE SAME LOT NUMBER: 4081841. ANOTHER DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. SUBSEQUENT TO THE INITIALLY FILED MDR REPORT, ADDITIONAL INFORMATION WAS OBTAINED: FEMORAL IMAGING WAS NOT PERFORMED. THERE WERE ONLY TWO PROSTYLES THAT MALFUNCTIONED, NOT THREE AS PREVIOUSLY FILED. THEREFORE, THIS COMPLAINT DEVICE WOULD NOT HAVE BEEN REPORTABLE; HOWEVER, SINCE THE INITIAL REPORT HAS ALREADY BEEN FILED, A FINAL REPORT IS REQUIRED. IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE HEAVILY CALCIFIED RIGHT COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE VIA A GREATER THAN 10F SHEATH HOLE PRIOR TO AN INTERVENTIONAL ABDOMINAL AORTIC ANEURYSM REPAIR PROCEDURE. REPORTEDLY, THE NEEDLES WERE UNABLE TO PASS THROUGH THE ARTERY DUE TO SEVERE CALCIFICATIONS. ANOTHER PROSTYLE WAS USED BUT THE SAME ISSUE OCCURRED. PRE-CLOSE WAS ABANDONED AND SURGICAL INTERVENTION WAS PERFORMED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A VESSEL PUNCTURE CLOSURE OF AN UNKNOWN VESSEL USING A PROSTYLE DEVICE. REPORTEDLY, AN ABNORMALITY WAS OBSERVED ON SEVERAL PROSTYLES FROM THE SAME LOT NUMBER: 4081841. ANOTHER DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1996271 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 4081841

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention