BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 9695002 · Received February 11, 2020

    Report

    Report Number
    2024168-2020-01365
    Event Type
    Injury
    Date Received
    February 11, 2020
    Date of Event
    February 3, 2020
    Report Date
    February 11, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADDITIONAL PROGLIDE DEVICE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. MULTIPLE LOT NUMBERS WERE PROVIDED; HOWEVER, THE ACCOUNT COULD NOT CONFIRM WHICH LOT NUMBER EXPERIENCED THE FAILURE TO ACHIEVE HEMOSTASIS REQUIRING SURGICAL INTERVENTION. THEREFORE, THE LOT HISTORY RECORD REVIEW ARE PROVIDED FOR ALL PROVIDED LOT NUMBERS. THE RESULTS ARE AS FOLLOWS: PART / LOT: 12673-03/ 9120241, DATE OF MANUFACTURE: 02-DECEMBER-2019, EXPIRATION DATE: 31-OCTOBER-2021, UNIQUE DEVICE IDENTIFIER (UDI) NUMBER: (B)(4). PART / LOT: 12673-03/9090241, DATE OF MANUFACTURE: 02-SEPTEMBER-2019, EXPIRATION DATE: 31-JULY-2021, UNIQUE DEVICE IDENTIFIER (UDI) NUMBER: (B)(4). PART / LOT: 12673-03/9101041, DATE OF MANUFACTURE: 10-OCTOBER-2019, EXPIRATION DATE: 31-AUGUST-2021, UNIQUE DEVICE IDENTIFIER (UDI) NUMBER: (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. 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. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT IN THE MODERATELY CALCIFIED RIGHT COMMON FEMORAL ARTERY WAS SUCCESSFULLY COMPLETED, WITHOUT ISSUE, WITH TWO PROGLIDE DEVICES, USING THE PRE-CLOSE TECHNIQUE, VIA A 7F SHEATH PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. THE SHEATH WAS UPSIZED TO 18F AND THE AAA PROCEDURE WAS COMPLETED. BLEEDING WAS OBSERVED DURING THE PROCEDURE AFTER UPSIZING TO THE LARGEST SHEATH USED. REPORTEDLY, THE SUCCESSFULLY PREPLACED SUTURES WERE TIGHTENED, BUT HEMOSTASIS WAS NOT ACHIEVED. ANOTHER PROGLIDE DEVICE WAS DEPLOYED AND THE SUTURE BROKE DURING KNOT TIGHTENING. AN ADDITIONAL PROGLIDE DEVICE WAS USED, BUT HEMOSTASIS WAS NOT ACHIEVED. A SURGICAL CUTDOWN WAS PERFORMED AND A TEAR WAS OBSERVED IN THE ARTERY PROXIMAL TO THE PROGLIDE SUTURES. THE PHYSICIAN OPINED THAT THIS COULD HAVE BEEN THE REASON FOR BLEEDING AROUND THE LARGEST SHEATH DURING THE PROCEDURE AND LIKELY WAS CAUSED BY UPSIZING THE SHEATH. THE DAMAGED PORTION OF THE ARTERY WAS REMOVED AND A VASCULAR PATCH WAS USED TO REPAIR THE ARTERY AND ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156319 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 12673-03 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention