BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3952646 · Received July 23, 2014

    Report

    Report Number
    2024168-2014-04708
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 2, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THEREFORE, THE REPORTED UNSPECIFIED DEVICE FAILURE COULD NOT BE CONFIRMED. HOWEVER, TWO STERILE, UNUSED DEVICES WITH THE SAME PART NUMBER AND THE SAME LOT AS THE COMPLAINT DEVICE WERE RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED DEVICES AND THE DEVICES PASSED WITH ACCEPTABLE RESULTS. NO MANUFACTURING OR ABNORMAL OBSERVATIONS WERE DETECTED. A ROOT CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE DETERMINED BASED ON THE INVESTIGATION FINDINGS FROM THE TESTED SAMPLES. 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 EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE ADDITIONAL PROGLIDE DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH TWO PROGLIDE DEVICES, USING A PRE-CLOSE TECHNIQUE, PRIOR TO A INTERNAL ILIAC ARTERY ANEURYSM STENT GRAFT PROCEDURE. REPORTEDLY, BOTH DEVICES FAILED. IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH ONE PROGLIDE DEVICE, USING A PRE-CLOSE TECHNIQUE, PRIOR TO A INTERNAL ILIAC ARTERY ANEURYSM STENT GRAFT PROCEDURE. REPORTEDLY, THE DEVICE FAILED. THE SHEATH ON THE LEFT WAS UPSIZED TO 12F AND THE SHEATH ON THE RIGHT WAS UPSIZED TO 8F. THE INTERNAL ILIAC ARTERY ANEURYSM STENT GRAFT PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED AT THE LEFT COMMON FEMORAL ARTERY BY CUT DOWN AND SURGICAL CLOSURE. MANUAL ARTERIAL COMPRESSION WAS APPLIED AT THE RIGHT COMMON FEMORAL ARTERY ARTERIOTOMY SITE TO ACHIEVE HEMOSTASIS. THE PATIENT WAS BROUGHT BACK TO SURGERY WHEN THERE WAS NO LEFT PEDAL PULSE. THE LOSS OF PULSE WAS DUE TO ARTERIAL SPASMING AT THE DISTAL PART OF THE LEFT ILIAC STENT GRAFT. A VIABAHN STENT WAS PLACED TO OPEN THE ARTERY. THE NURSE STATED THAT THE SPASMING WAS CAUSED BY TORTUOSITY OF THE INTERNAL ILIAC ARTERY AND NOT THE PROGLIDE DEVICE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431422 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30408K1

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention SHEATH: 8F, 12F