BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 19454306 · Received June 3, 2024

    Report

    Report Number
    2024168-2024-06545
    Event Type
    Injury
    Date Received
    June 3, 2024
    Date of Event
    May 15, 2024
    Report Date
    August 15, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648235184
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED TO THE RETURNED DEVICE. THE REPORTED DIFFICULT TO INSERT THE GUIDE WIRE WAS CONFIRMED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTION (CAPA) REVIEWS WERE PERFORMED AND REVEALED THAT THIS EVENT HAS BEEN DEEMED TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THE REPORTED DIFFICULTY TO INSERT THE GUIDE WIRE WAS CONCLUDED TO BE RELATED TO POTENTIAL PRODUCT QUALITY ISSUE DUE TO THE PINCHED SEAL VALVE INSIDE THE SHEATH. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT VASCULAR WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES. THE UNEXPECTED MEDICAL INTERVENTION APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. CORRECTIONS: D1 ¿ BRAND NAME: UPDATED. D2A ¿ COMMON DEVICE NAME: UPDATED. D3 ¿ NAME, ADDRESS 1, CITY, POSTAL CODE: UPDATED. D4 - LOT #: UPDATED FROM 4022842 TO: 4022341. D4 - PRIMARY UDI NUMBER: UPDATED FROM (B)(4). H4 - DEVICE MFG DATE: UPDATED FROM 2/28/2024 TO 2/23/2024.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A VENOTOMY CLOSURE OF A RIGHT COMMON FEMORAL VEIN USING A PROSTYLE DEVICE AFTER AN INTERVENTIONAL CARDIAC ABLATION PROCEDURE WITH A LARGE-BORE SHEATH. REPORTEDLY, IT WAS DIFFICULT TO INSERT THE GUIDEWIRE (0.035 INCH) IN THE PROSTYLE¿S GUIDEWIRE LUMEN. THE DEVICE WAS REMOVED, AND THE GUIDEWIRE LUMEN WAS SOAKED IN SALINE; HOWEVER, THE GUIDEWIRE WAS STILL UNABLE TO BE INSERTED. A NEW PROSTYLE 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
    2319650 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-03 4022341 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention