BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1912095 · Received December 1, 2010

    Report

    Report Number
    2953144-2010-03053
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DEVICE #1 - PROGLIDE (PART #12673-03; LOT #890226H), WILL BE FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED PLUNGER FOUND THE ANTERIOR CUFF WAS MISSED AND THIS CONFIRMED THE REPORTED EVENT. THE ANTERIOR NEEDLE TIP APPEARED NORMAL. DURING THE INVESTIGATION, THE PLUNGER WAS LOADED IN A PROXY DEVICE AND THE PUSH MANDREL TRAVEL WAS TESTED AND THE RESULTS WERE ACCEPTABLE. BASED ON THE INVESTIGATION FINDINGS, THE MOST PROBABLE ROOT CAUSE FOR THE ANTERIOR CUFF MISS IS NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE DURING NEEDLE DEPLOYMENT. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A WIRE FRACTURE OCCURRED. THE 90 MM IN LENGTH LESION WAS LOCATED IN THE CALCIFIED DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). INITIALLY A NON-BSC GUIDE WIRE WAS ADVANCED TO THE LESION, AND THIS WAS EXCHANGED FOR THE FLOPPY ROTAWIRE GUIDE WIRE USING A NON-BSC MICROCATHETER. A 1.5MM ROTALINK PLUS BURR WAS ADVANCED, AND 5 RUNS AT 15 SECONDS EACH WERE PERFORMED WITH THE BURR SUCCESSFULLY CROSSING THE LESION. THE 1.5MM BURR AND FLOPPY ROTAWIRE GUIDE WIRE WERE REMOVED, AND THE PHYSICIAN NOTED THAT THE DISTAL PORTION OF THE FLOPPY ROTAWIRE GUIDE WIRE WAS DETACHED AND REMAINED IN THE DISTAL LAD. NO RESISTANCE WAS NOTED WITH THE BURR AND WIRE. THE PROCEDURE WAS COMPLETED WITH DEPLOYMENT OF THREE STENTS IN THE DISTAL LAD AND POST-DILATION. THE PHYSICIAN FEELS THAT THE WIRE FRAGMENT IS SECURE IN THE DISTAL LAD. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS IS LISTED AS "TAKING A WAIT AND SEE APPROACH".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED, A POSTERIOR CUFF MISS OCCURRED. THE DEVICE WAS REMOVED AND A SECOND PROGLIDE DEVICE WAS USED AND AN ANTERIOR CUFF MISS OCCURRED. HEMOSTASIS WAS ACHIEVED USING A NON-ABBOTT DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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-REDWOOD CITY 890386H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DEVICE #1:PROGLIDE (PART #12673-03, LOT #890226H)