BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2232072 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06111
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 17, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THE RETURN OF THE DEVICE MAY HAVE ASSISTED THE INVESTIGATION OF THE REPORTED EVENT. A CUFF MISS (SUTURE NOT PRESENT) CAN BE INFLUENCED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING, USER TECHNIQUE AND/OR PATIENT ANATOMICAL CONDITIONS. DURING MANUFACTURING, THE NEEDLE TRAJECTORY OF EVERY DEVICE IS VERIFIED AND A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. USER TECHNIQUE, SUCH AS, FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45 DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATING THE DEVICE AT ANY POINT DURING PLUNGER/NEEDLE DEPLOYMENT, AGGRESSIVELY DEPLOYING OR REMOVING THE PLUNGER AND/OR INADEQUATE POSITIONING OF THE FOOT AGAINST THE ARTERIAL WALL MAY CAUSE A CUFF MISS. INFORMATION ABOUT USER TECHNIQUE WAS NOT PROVIDED. PATIENT ANATOMY (E.G. CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.) MAY CONTRIBUTE TO A CUFF MISS. PATIENT ARTERY WAS REPORTEDLY MILDLY CALCIFIED. THE PROGLIDE INSTRUCTIONS FOR USE STATES: THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE SMC DEVICES HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. A CONCLUSIVE CAUSE FOR THE REPORTED NEEDLE TO CUFF MISS CANNOT BE DETERMINED. HOWEVER, IT IS LIKELY THAT THE REPORTED VESSEL CALCIFICATION CONTRIBUTED TO THE REPORTED CUFF MISS. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. BASED ON THIS REVIEW A PRODUCT QUALITY DEFICIENCY WAS NOT NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. REPORTEDLY, THE PROGLIDE WAS USED IN A CALCIFIED VESSEL. PER THE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF A MILDLY CALCIFIED COMMON FEMORAL ARTERY USING A PROGLIDE DEVICE AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, WHEN THE PLUNGER WAS RETRACTED THE RAIL SUTURE WAS NOT VISIBLE. THE PROGLIDE DEVICE WAS REMOVED FROM THE ANATOMY AND HEMOSTASIS WAS ACHIEVED USING MANUAL ARTERIAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THE PHYSICIAN IS REPORTED TO BE IN-TRAINING IN THE USE OF THE PROGLIDE DEVICE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. 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 030016H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention