BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3941232 · Received July 17, 2014

    Report

    Report Number
    2024168-2014-04587
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 25, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION LOT# CHANGED FROM 30918K1 TO 31206K1. FAILURE TO FOLLOW STEPS/INSTRUCTIONS - A FEMORAL ANGIOGRAM WAS NOT TAKEN. A VENOUS SHEATH WAS REPORTED TO BE NEXT TO THE ARTERIAL SHEATH DURING CLOSING. PER THE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH IPSILATERAL FEMORAL VENOUS SHEATH DURING THE CATHETERIZATION PROCEDURE. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE KNOT, SUTURE TRIMMER, AND SNARE KNOT PUSHER WERE NOT RETURNED AND THE REPORTED SUTURE BREAK WAS NOT CONFIRMED. BASED ON A VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT WAS REPORTED THAT A FEMORAL ANGIOGRAM WAS NOT TAKEN. THE PROGLIDE INSTRUCTIONS FOR USE STATES: PRIOR TO DEPLOYMENT OF THE PERCLOSE PROGLIDE SMC DEVICE, PERFORM A FEMORAL ANGIOGRAM TO EVALUATE THE FEMORAL ARTERY SITE FOR VESSEL SIZE, CALCIUM DEPOSITS, TORTUOSITY, AND FOR DISEASE OR DISSECTIONS OF THE ARTERIAL WALL TO AVOID DEVICE CUFF MISSES (DEVICE NEEDLES NOT ENGAGING WITH THE CUFFS) AND/OR POSTERIOR WALL SUTURE PLACEMENT AND POSSIBLE LIGAT ON OF THE ANTERIOR AND POSTERIOR WALLS OF THE FEMORAL ARTERY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. THE PROCEDURE WAS DIAGNOSTIC. THE ACCESS SITE WAS A COMMON FEMORAL ARTERY. A FEMORAL ANGIOGRAM WAS NOT TAKEN PRIOR TO THE PROCEDURE. THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE. A 6FR PROCEDURAL SHEATH WAS USED. A SECOND PROGLIDE WAS USED TO ACHIEVE HEMOSTASIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A SUTURE BREAK OCCURRED. THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT REPORTED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. AS THE NAME OF THE PHYSICIAN WAS PROVIDED BY THE HOSPITAL, IT IS UNKNOWN IF THE PHYSICIAN HAS BEEN TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419809 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 31206K1

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention SHEATH: 6FR