BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2760928 · Received September 26, 2012

    Report

    Report Number
    2024168-2012-06074
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    September 3, 2012
    Report Date
    September 3, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED GUIDE DETACHMENT WAS CONFIRMED. BASED ON VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE PROBABLE CAUSE FOR THE REPORTED EVENT WAS DETERMINED TO BE MOST LIKELY RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT-HANDLING DATABASE FROM THIS LOT INDICATED DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION RECEIVED INDICATES THE LEFT COMMON FEMORAL ARTERY WAS VERY CALCIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS ATTEMPTED IN THE CALCIFIED AND TORTUOUS LEFT COMMON FEMORAL ARTERY (LCFA) USING THE PRECLOSE TECHNIQUE PRIOR TO AN ABDOMINAL AORTIC ANEURYSM REPAIR. REPORTEDLY, WHEN ATTEMPTING TO INSERT THE PROGLIDE DEVICE INTO THE VESSEL, THE END PIECE OF THE PROGLIDE BROKE OFF AND THE DISTAL HALF OF THE GUIDE REMAINED INSIDE PATIENT'S LCFA. OPEN PROCEDURE WAS REQUIRED TO RETRIEVE THE PROGLIDE PIECE FROM THE ARTERY. THE INDEX PROCEDURE WAS COMPLETED AND A VASCULAR PATCH WAS USED TO CLOSE THE VESSEL. THERE WAS A REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE INTERVENTION PERFORMED TO REMOVE THE PROGLIDE PIECE FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20623J1

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention