BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 10796405 · Received November 5, 2020

    Report

    Report Number
    2024168-2020-09284
    Event Type
    Injury
    Date Received
    November 5, 2020
    Date of Event
    October 15, 2020
    Report Date
    November 5, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    08717648013089
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT COULD NOT BE CONFIRMED WHICH PROGLIDE DEVICE LOT NUMBER EXPERIENCED THE REPORTED PATIENT EFFECTS; THEREFORE, THE LOT HISTORY RECORD REVIEWS ARE PROVIDED FOR BOTH LOT NUMBERS (0082041 AND 0083042). PART/LOT: 12673-03/LOT# 0082041. EXPIRATION DATE: 30-JUNE-2022. UNIQUE DEVICE IDENTIFIER NUMBER: (B)(4). DATE OF MANUFACTURE: 20-AUGUST-2020. PART/LOT: 12673-03/LOT# 0083042. EXPIRATION DATE: 30-JUNE-2022. UNIQUE DEVICE IDENTIFIER NUMBER: (B)(4). DATE OF MANUFACTURE: 30-AUGUST-2020. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORDS IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOTS THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORIES DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES; HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT IN THE RIGHT COMMON FEMORAL ARTERY WAS ACHIEVED WITH TWO PROGLIDE DEVICES (LOT# 0082041 AND LOT# 0083042), USING THE PRE-CLOSE TECHNIQUE PRIOR TO A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. REPORTEDLY, THE SHEATH WAS UPSIZED TO 14F AND THE TAVR PROCEDURE WAS COMPLETED. THE TWO PREPLACED SUTURES DID NOT ACHIEVE HEMOSTASIS. IT COULD NOT BE DETERMINED IF THE SECOND PROGLIDE PLACED WAS LOT# 0082041 OR LOT# 0083042. HEMOSTASIS WAS ACHIEVED WITH MANUAL ARTERIAL COMPRESSION AND A FEMOSTOP. 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
    1256708 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 12673-03 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention