BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3973667 · Received August 1, 2014

    Report

    Report Number
    2024168-2014-04919
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 7, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE FIVE OTHER PERCLOSE PROGLIDE DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE PLUNGER AND ITS ANTERIOR NEEDLE WERE NOT RETURNED. A PROXY PLUNGER WAS RETRACTED WITHOUT ANY OBSERVABLE RESISTANCE, THEREFORE, THE REPORTED FAILURE TO DEPLOY THE PLUNGER WAS NOT CONFIRMED. THE LEVER HAD BEEN CLOSED AND THE FOOT HAD BEEN RETRACTED INTO THE GUIDE. THE SUTURE WAS RETURNED PARTIALLY EXPOSED FROM THE POSTERIOR NEEDLE SLOT AND ITS PRE-TIED KNOT WAS UNRAVELED. THE POSTERIOR NEEDLE TIP HAD BEEN EJECTED FROM THE SHANK AND WAS STILL ATTACHED TO THE RAIL SUTURE. THE POSTERIOR NEEDLE TIP SHOWED NO INDICATION OF ENGAGEMENT WITH THE POSTERIOR CUFF. THE POSTERIOR CUFF WAS STILL IN THE POCKET. THE ANTERIOR CUFF HAD BEEN SEPARATED FROM THE NEEDLE. ONE OF THE ANTERIOR CUFF TABS (MEASURING APPROXIMATELY 0.01 BY 0.01 INCHES) WAS BROKEN OFF AND WAS NOT RETURNED WITH THE DEVICE. BASED ON A VISUAL AND FUNCTIONAL INSPECTION 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AND AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY WERE ATTEMPTED WITH 3 PROGLIDE DEVICES ON EACH SIDE, USING A PRE-CLOSE TECHNIQUE, VIA A 6F SHEATH PRIOR TO A ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. REPORTEDLY, THE PLUNGER WOULD NOT COMPLETELY DEPRESS ON ALL SIX DEVICES. TWO ADDITIONAL PROGLIDE DEVICES WERE USED FOR SUCCESSFUL SUTURE PLACEMENT ON THE RIGHT SIDE. THE SHEATHS WERE UPSIZED TO 16F AND THE EVAR PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED ON THE RIGHT SIDE WITH THE SUCCESSFULLY PLACED SUTURES OF THE ADDITIONAL PROGLIDE DEVICES. ON THE LEFT SIDE A SURGICAL CUTDOWN WAS PERFORMED AND HEMOSTASIS WAS ACHIEVED SURGICALLY. THERE WAS A DELAY IN THE PROCEDURE DUE TO THE CUT DOWN BUT NO PATIENT IMPACT WAS REPORTED. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE AND IN THE LARGE HOLE TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO FILING OF INITIAL MEDWATCH MFR REPORT ADDITIONAL INFORMATION WAS RECEIVED: THE PATIENT IS REPORTED TO BE DOING FINE AND WITH NO REPORTED ADVERSE PATIENT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450015 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40507K1

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention SHEATH: 6F, 16F, HEPARIN