BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2132141 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04285
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED COMPONENTS BODY OF THE DEVICE, HANDLE TO FOOT FUNCTION, GUIDE TUBE, NEEDLE GUIDE, BRIDGE, SUTURE BEARING, EXIT RAMP AND SHEATH WERE NORMAL, THERE WAS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY THAT WOULD CONTRIBUTE TO THE REPORTED CUFF MISS. THE POSTERIOR CUFF WAS STILL LOADED ON THE FOOT. BOTH CUFFS WERE ATTACHED TO THE LINK AND THE ANTERIOR CUFF TABS WERE DAMAGED AND BENT. BASED ON THE EVIDENCE, THE POSTERIOR CUFF WAS MISSED AND THE REPORTED COMPLAINT WAS CONFIRMED. THE ANTERIOR CUFF DETACHED FROM THE NEEDLE TIP WHICH WAS A DIRECT RESULT OF THE POSTERIOR CUFF MISS. BECAUSE THE NEEDLE DID NOT ENGAGE THE POSTERIOR CUFF, THE CUFF WAS NOT EJECTED FROM THE FOOT. 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. THIS RESULTED IN THE ANTERIOR CUFF DETACHING FROM THE NEEDLE. THE ANTERIOR CUFF TABS WERE DAMAGED AND BENT. ONE OF THE ANTERIOR CUFF TABS WAS BROKEN OFF AND WAS NOT RETURNED WITH THE DEVICE. CUFF TABS MEASURE ONE ONE-HUNDREDTH (0.01) OF AN INCH SQUARE. DUE TO THE EXTREMELY SMALL SIZE, A MISSING CUFF TAB IS NOT VISIBLE WITHOUT MAGNIFICATION AND WOULD NOT BE NOTED BY THE USER. THE NEEDLE TRAJECTORY COULD NOT BE CHECKED AS THERE WAS TOO MUCH DRIED BLOOD INSIDE THE NEEDLE LUMENS PREVENTING REINSERTION OF THE PLUNGER. BASED ON THE INVESTIGATION FINDINGS, THE MOST PROBABLE CAUSE FOR THE POSTERIOR CUFF MISS IS NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE BECAUSE OF CHALLENGING ANATOMIES (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.) OR FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45-DEGREE ANGLE THROUGHOUT DEPLOYMENT. THE PROBABLE CAUSE FOR THE NEEDLE TO CUFF MISS IS RELATED TO THE OPERATIONAL CONTEXT IN THE USE OF THE DEVICE. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY RELEVANT NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A MODERATELY CALCIFIED COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS PULLED BACK NO SUTURE WAS CONNECTED TO THE ANTERIOR NEEDLE. THE DEVICE WAS REMOVED FROM THE TREATED GROIN AND MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 040076H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEPARIN