BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 8781820 · Received July 11, 2019

    Report

    Report Number
    2024168-2019-10033
    Event Type
    Injury
    Date Received
    July 11, 2019
    Date of Event
    June 18, 2019
    Report Date
    September 3, 2019
    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 · 0

    G9: EXEMPTION NUMBER E2019001-PERMITS NUMBERING SEQUENCE TO BEGIN WITH 10000, TO AVOID DUPLICATION OF REPORT NUMBERS DUE TO PROCESS TRANSITION. THERE MAY BE GAPS IN NUMBERING FOR REPORTS SUBMITTED DURING THE TRANSITION PERIOD. DEVICE CODE 2017 - AGAINST RESISTANCE. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER PROGLIDE DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MANUFACTURING REPORT NUMBERS.NA

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2019001-PERMITS NUMBERING SEQUENCE TO BEGIN WITH 10000, TO AVOID DUPLICATION OF REPORT NUMBERS DUE TO PROCESS TRANSITION. THERE MAY BE GAPS IN NUMBERING FOR REPORTS SUBMITTED DURING THE TRANSITION PERIOD. ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED DIFFICULTY DEPLOYING THE PLUNGER COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS THEY WERE RELATED TO PROCEDURE CIRCUMSTANCE. THE REPORTED NEEDLE TO CUFF MISS AND FOOT DETACHMENT WERE CONFIRMED. 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 DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. IT SHOULD BE NOTED THAT THE PROGLIDE INSTRUCTIONS FOR USE STATES: DO NOT ADVANCE OR WITHDRAW THE PERCLOSE PROGLIDE SMC DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THAT RESISTANCE HAS BEEN DETERMINED. THE REPORTED DIFFICULTIES AND PATIENT EFFECT OF FOREIGN BODY IN PATIENT APPEAR TO BE RELATED TO PROCEDURE CIRCUMSTANCE DUE TO INTERACTION WITH THE PATIENT CALCIFICATION. THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO PROCEDURE CIRCUMSTANCE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE. DEVICE CODE 4012 REMOVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SUTURE PLACEMENT IN THE MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH FOUR PROGLIDE DEVICES USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH PRIOR TO A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. REPORTEDLY, WHEN THE PLUNGER WAS PUSHED IN THERE WAS RESISTANCE AND PUSH BACK OF THE PLUNGER. THE NEEDLES WERE DEPLOYED WITH NO SUTURE DURING PLUNGER REMOVAL FOR ALL FOUR PROGLIDE. A POSTERIOR FOOT FROM EACH OF THE DEVICES WAS FOUND SEPARATED FROM THE DEVICE AFTER THE PROCEDURE. THE PHYSICIAN IS UNSURE IF ANY OF THE FEET REMAINED THE ANATOMY; THE FEET WERE NOT FOUND. THE SUTURES OF TWO NEW PROGLIDE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE TAVR PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROGLIDE SUTURES. THERE WAS REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SUTURE PLACEMENT IN THE MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH FOUR PROGLIDE DEVICES USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH PRIOR TO A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. REPORTEDLY, WHEN THE PLUNGER WAS PUSHED IN THERE WAS RESISTANCE AND PUSH BACK OF THE PLUNGER. THE NEEDLES WERE DEPLOYED WITH NO SUTURE DURING PLUNGER REMOVAL FOR ALL FOUR PROGLIDE. A POSTERIOR FOOT FROM EACH OF THE DEVICES WAS FOUND BROKEN AFTER THE PROCEDURE; NONE OF THE FEET WERE FOUND. THE SUTURES OF TWO NEW PROGLIDE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE TAVR PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROGLIDE SUTURES. 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
    574670 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 9032741 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention 6F SHEATH| 6F SHEATH| HEPARIN| HEPARIN| 6F SHEATH| HEPARIN