BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1930564 · Received December 16, 2010

    Report

    Report Number
    2953144-2010-03252
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 22, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE YIELDED THE FOLLOWING OBSERVATIONS. ABOUT HALF INCH OF THE MONOFILAMENT WAS EXPOSED AT THE GUIDE AND THE NEEDLE TIP STILL ATTACHED TO THE RAIL END. THE ORIGINAL PLUNGER WAS NOT RETURNED. THE POSTERIOR CUFF WAS STILL LOADED ON THE FOOT RESULTING IN A POSTERIOR CUFF MISS AS REPORTED BY THE CUSTOMER. BECAUSE THE NEEDLE DID NOT ENGAGE THE POSTERIOR CUFF, THE CUFF WAS NOT EJECTED FROM THE FOOT. BOTH CUFFS WERE ATTACHED TO THE LINK AND THE ANTERIOR CUFF TABS WERE DAMAGED AND BENT. ONE OF THE ANTERIOR CUFF TABS (304 STAINLESS STEEL, APPROX. 0.01 BY 0.01 INCHES SQUARE) WAS BROKEN OFF AND WAS NOT RETURNED WITH THE DEVICE. WHEN THE PLUNGER WAS REMOVED FROM THE DEVICE, THE LINK WAS HELD ON ONE END BY THE POSTERIOR CUFF IN THE FOOT POCKET WHILE BEING PULLED ON THE OTHER END BY THE WITHDRAWAL OF THE PLUNGER. THE ANTERIOR CUFF DETACHED FROM THE NEEDLE TIP AS A DIRECT RESULT OF THE POSTERIOR CUFF MISS. DURING THE INVESTIGATION, A PROXY PLUNGER WAS REINSERTED AND THE NEEDLE TRAJECTORY WAS ACCEPTABLE. BECAUSE LAB TESTING OF THE DEVICE RESULTED IN ACCEPTABLE NEEDLE TRAJECTORY, 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. THERE WERE NO MANUFACTURING OR QUALITY ISSUES DETECTED THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

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

    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 AN UNSPECIFIED PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. IT WAS NOT REPORTED HOW HEMOSTASIS WAS ACHIEVED; HOWEVER, THE PHYSICIAN INDICATED THAT THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED TO PLACE SUTURES FOR POST-PROCEDURE ARTERIOTOMY CLOSURE USING THE PRECLOSE TECHNIQUE IN BOTH THE RIGHT AND THE LEFT FEMORAL ARTERIES PRIOR TO AN INTERVENTIONAL PROCEDURE (AORTIC ABDOMINAL ANEURYSM/ENDOGRAFT). REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED A SUTURE RETRIEVAL ISSUE OCCURRED (EITHER NO SUTURES PRESENT OR ONLY ONE SUTURE WAS PRESENT). THE DEVICE WAS REMOVED AND ANOTHER PROGLIDE DEVICE WAS PLACED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED AT THE END OF THE INTERVENTIONAL PROCEDURE USING THE PRE-PLACED SUTURES. IT WAS REPORTED THAT A POSSIBLE UNSPECIFIED "USER ERROR" MAY HAVE CONTRIBUTED TO THE EVENT. 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 900026H

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention