BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2180330 · Received July 27, 2011

    Report

    Report Number
    2024168-2011-05309
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 9, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS 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 ANTERIOR CUFF WAS ENGAGED TO ANTERIOR NEEDLE TIP AND BOTH CUFFS WERE ATTACHED TO THE LINK. THE POSTERIOR CUFF WAS OUT OF THE POCKET AND THE POSTERIOR CUFF TABS WERE UNDISTURBED, INDICATING THAT A POSTERIOR CUFF MISS OCCURRED. THERE WAS NO NEEDLE STRIKE MARK ON THE POSTERIOR FOOT. DURING TESTING, THE PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY, NEEDLE DEPTH AND PUSH MANDREL TRAVEL AND THE RESULTS WERE ACCEPTABLE. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED DURING MANUFACTURING. 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. ALTHOUGH IT WAS REPORTED THAT A 10FR SHEATH WAS USED DURING INSERTION OF THE DEVICES, THIS WOULD NOT HAVE CONTRIBUTED TO THE REPORTED EXPERIENCE. 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 RELEVANT INFORMATION. THE SECOND PROGLIDE DEVICE IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED PLACEMENT OF THE PROGLIDE SUTURE OF TWO PROGLIDE DEVICES USING THE PRE-CLOSE TECHNIQUE PRIOR TO A INTERVENTIONAL PROCEDURE IN THE COMMON FEMORAL ARTERY. REPORTEDLY, FOUR PROGLIDE DEVICES WERE PLACE; HOWEVER, TWO OF THE PROGLIDE DEVICES EXPERIENCED CUFF MISSES. HEMOSTASIS WAS ACHIEVED WITH THE REMAINING TWO PROGLIDE DEVICES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. A 10FR SHEATH WAS USED DURING INSERTION OF THE DEVICES. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN WAS TRAINED IN THE USE OF THE PROGLIDE DEVICE. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 040356H

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention HEPARINSHEATH: 10F