BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2222482 · Received August 25, 2011

    Report

    Report Number
    2024168-2011-05936
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 17, 2011
    Report Date
    August 4, 2011
    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): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IT WAS REPORTED THAT THE PROGLIDE DEVICE WAS USED IN A MILDLY 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. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    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 COMPLAINT. A CUFF MISS CAN BE INFLUENCED BY NUMEROUS FACTORS INCLUDING, BUT IS NOT LIMITED TO A MANUFACTURING DEFICIENCY, 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. REPORTEDLY, THE ARTERIES OF THE PATIENT WERE MILDLY CALCIFIED. THE PROGLIDE INSTRUCTIONS FOR USE, UNDER SPECIAL PATIENT POPULATION INDICATES THAT 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. IT IS LIKELY THAT THE REPORTED CALCIFICATION CONTRIBUTED TO THE NEEDLE TO CUFF MISS THAT RESULTED IN HEMORRHAGING AND REQUIRED AN ADDITIONAL CLOSURE DEVICE AND THERAPY/NON-SURGICAL TREATMENT TO CLOSE THE VESSEL. REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE DOES NOT APPEAR TO BE AN INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. BASED ON THE REVIEW OF THE LOT HISTORY RECORD, THE QUERY OF THE COMPLAINT HANDLING DATABASES, EVENT INFORMATION AND TESTING/INSPECTION CRITERIA FOR THIS LOT, A PRODUCT QUALITY DEFICIENCY WAS NOT NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A MILDLY CALCIFIED COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE AFTER A DIAGNOSTIC PROCEDURE WHICH USED A 6F SHEATH. REPORTEDLY, A POSTERIOR CUFF MISS OCCURRED. THE SITE WAS RE-WIRED AND HEMOSTASIS WAS ACHIEVED USING A SECOND PROGLIDE DEVICE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE PERCLOSE 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 040486H

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention SHEATH: 6F