BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1904987 · Received November 22, 2010

    Report

    Report Number
    2953144-2010-02917
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 26, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT THE MONOFILAMENT WAS EXPOSED APPROXIMATELY 1 INCH AT THE GUIDE WITH THE NEEDLE TIP STILL ATTACHED TO THE RAIL END. THE POSTERIOR CUFF WAS STILL LOADED ON THE FOOT AND THE LINK STILL ATTACHED TO THE CUFF. THE ANTERIOR CUFF WAS ENGAGED TO ANTERIOR NEEDLE TIP. THERE WAS NO NEEDLE STRIKE MARK ON THE FOOT. THE POSTERIOR CUFF WAS MISSED AND THE LINK WAS BROKEN AT THE ANTERIOR CUFF WHICH WAS A DIRECT RESULT OF THE POSTERIOR CUFF MISS. BECAUSE THE POSTERIOR CUFF REMAINED IN THE FOOT, IT CAUSED THE LINK TO BREAK FROM THE ANTERIOR CUFF DURING PLUNGER REMOVAL. DURING THE INVESTIGATION, PLUNGER WAS INSERTED AND THE NEEDLE TRAJECTORY, NEEDLE DEPTH AND PUSH MANDREL TRAVEL WERE ACCEPTABLE. BASED ON THE INVESTIGATION FINDINGS, THE MOST PROBABLE ROOT CAUSE FOR THE POSTERIOR 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 ISSUE WAS DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.(B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.

    Description of Event or Problem · 1

    THE CARE GIVER (CG) OF THE HOME PATIENT CONTACTED THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) TO GET ASSISTANCE WITH ENDING THERAPY SO THEY CAN GO TO THE HOSPITAL. THE TSR ASSISTED THE CG TO END THE THERAPY. THE HOME PATIENT'S NURSE STATED THAT THE PATIENT HAD PERITONITIS BUT COULD NOT GIVE ANY ADDITIONAL INFORMATION. THE PATIENT IS CURRENTLY PERFORMING PERITONEAL DIALYSIS THERAPY WITH NO PROBLEMS.

    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 COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED, A CUFF MISS OCCURRED. THE PROGLIDE WAS REMOVED AND A SECOND PROGLIDE DEVICE WAS USED WITH THE SAME RESULTS. 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 930076H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention