BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 16864981 · Received May 3, 2023

    Report

    Report Number
    2024168-2023-04695
    Event Type
    Injury
    Date Received
    May 3, 2023
    Date of Event
    March 31, 2023
    Report Date
    August 24, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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.

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE DEVICE CONDITION INDICATES THE PLUNGER MAY NOT HAVE BEEN FULLY DEPRESSED FLUSH WITH THE HANDLE SUCH THAT THE POSTERIOR NEEDLE WAS NOT BLOWN THROUGH THE POSTERIOR FOOT. THE LINK DETACHMENT SUBSEQUENTLY OCCURRED DURING PLUNGER RETRACTION AS THE POSTERIOR NEEDLE REMAINED IN THE POSTERIOR POCKET. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE REPORTED DIFFICULTIES AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO THE 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.D4 LOT # CHANGED FROM LOT# 2070442 TO LOT# 2113041.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE AFTER A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY INTERVENTIONAL PROCEDURE USING A 6F SHEATH. REPORTEDLY, WHILE ADVANCING THE KNOT, THE SUTURE BROKE. ANOTHER PROGLIDE 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
    859472 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 2113041

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention