BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 4760233 · Received May 8, 2015

    Report

    Report Number
    2024168-2015-02617
    Event Type
    Injury
    Date Received
    May 8, 2015
    Date of Event
    April 16, 2015
    Report Date
    April 16, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SUTURE MEDIATED CLOSURE (SMC) SYSTEM WAS RETURNED FOR ANALYSIS. THE REPORTED SUTURE RETRIEVAL ISSUE WAS CONFIRMED. IN ADDITION, ONE OF THE ANTERIOR CUFF TABS MEASURING ONE ONE-HUNDREDTH (0.01) OF AN INCH SQUARE WAS BROKEN OFF AND WAS NOT RETURNED WITH THE DEVICE. DUE TO THE EXTREMELY SMALL SIZE, A MISSING CUFF TAB IS NOT VISIBLE WITHOUT MAGNIFICATION AND WOULD NOT BE NOTED BY THE USER. BASED ON A VISUAL/FUNCTIONAL INSPECTION ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE REPORTED SUTURE RETRIEVAL ISSUE AND APPLYING MANUAL ARTERIAL COMPRESSION TO ACHIEVE HEMOSTASIS APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: DILATATION CATHETER: SAPPHIRE II 1.0/50, TRAVELER 2.0/12; GUIDE WIRE: XTA, GUIA 1ST, RUNTHROUGH FLOPPY; GUIDE CATHETER: HEARTRAIL II BL3.5M 6FR; STENT: XIENCE ALPINE 2.5/28, 2.75/18; PLAVIX, BAYER ASPIRIN. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER A PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE. REPORTEDLY, THE PLUNGER WAS RETRACTED; HOWEVER, THE SUTURE WAS NOT PRESENT. THE BLUE SUTURE WAS FOUND "BURYING" IN THE SKIN NEAR THE PUNCTURE SITE. HEMOSTASIS WAS ACHIEVED BY APPLYING MANUAL ARTERIAL COMPRESSION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED: IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE WITH A 6F SHEATH AFTER A PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303959 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40723K1

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention CONCOMITANT MEDICAL PRODUCTS| SHEATH: 6F