BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2210945 · Received August 12, 2011

    Report

    Report Number
    2024168-2011-05727
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    November 18, 2009
    Report Date
    July 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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. SHEATH: 6 FR; STENT: XIENCE V (2.5 X 23 MM, 2.5 X 12 MM), OTHER: 2% LIDOCAINE, VERSED IV 1 MG, FENTANYL IV 50 MCG. 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 IN THE INVESTIGATION OF THE EVENT. IN THIS CASE, A SPECIFIC DEVICE FAILURE WAS NOT REPORTED. HEMORRHAGING AND THE USE OF AN ADDITIONAL DEVICE WERE LIKELY DUE TO LACK OF HEMOSTASIS. LACK OF HEMOSTASIS CAN BE INFLUENCED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO: MANUFACTURING, USER TECHNIQUE AND PATIENT ANATOMY. A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE INCLUDING SUTURE PLACEMENT. ROTATING THE DEVICE DURING PLUNGER/NEEDLE DEPLOYMENT AND FAILURE TO MAINTAIN ADEQUATE FOOT POSITION AGAINST THE ARTERIAL WALL CAN CONTRIBUTE TO THE REPORTED EVENT; HOWEVER, INFORMATION ABOUT USER TECHNIQUE WAS NOT PROVIDED. THE ANATOMICAL CONDITIONS REPORTED (CORONARY ARTERY DISEASE, ANGINA, ACUTE CORONARY SYNDROME, HYPERTENSION, DYSLIPIDEMIA, FORMER TOBACCO USE AND PREVIOUS CORONARY INTERVENTION) MAY HAVE CONTRIBUTED TO THE REPORTED EXPERIENCE; HOWEVER, THIS COULD NOT BE CONFIRMED. IT IS NOT POSSIBLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED UNSPECIFIED DEVICE FAILURE WHICH REQUIRED AN ADDITIONAL CLOSURE DEVICE AND THERAPY/NON-SURGICAL TREATMENT TO ACHIEVE HEMOSTASIS. 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 DID NOT REVEAL OTHER REPORTED INCIDENTS WITHOUT A SPECIFIC MODE OF FAILURE. DURING MANUFACTURING SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE INCLUDING SUTURE PLACEMENT. THERE DOES NOT APPEAR TO BE AN INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE CLINICAL TRAIL MENTIONED IN THE INITIAL MEDWATCH REPORT DOES NOT INCLUDE THE PROGLIDE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A CLINICAL TRIAL, THAT A PHYSICIAN PERFORMED SUCCESSFUL CORONARY STENTING OF ISR (IN-STENT RESTENOSIS), AND FOLLOWING THE INTERVENTIONAL PROCEDURE ARTERIOTOMY CLOSURE OF THE RIGHT FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE. THE PROGLIDE DEVICE FAILED AND A SECOND PROGLIDE WAS SUCCESSFULLY USED TO ACHIEVE HEMOSTASIS. 2% LIDOCAINE WAS USED IN THE RIGHT GROIN. THERE WERE NO ADVERSE PATIENT EFFECTS. THE ATTENDING PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE, ALTHOUGH IT IS NOT KNOWN WHO WAS THE OPERATOR OF THE DEVICE. THOUGH REQUESTED, 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 820266H

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention