BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2212200 · Received August 15, 2011

    Report

    Report Number
    2024168-2011-05743
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE RETURN OF THE DEVICE MAY HAVE ASSISTED THE INVESTIGATION OF THE COMPLAINT. THEREFORE, A CONCLUSIVE CAUSE TO THE REPORTED SUTURE BREAK AND THE DIFFICULTY REMOVING THE DEVICE THAT REQUIRED THERAPY/NON-SURGICAL TREATMENT COULD NOT BE DETERMINED. A DIFFICULT TO REMOVE DEVICE, AND A SUTURE BREAK CAN BE CAUSED BY A NUMBER OF FACTORS INCLUDE MANUFACTURING, USER TECHNIQUE OR PATIENT ANATOMICAL CONDITIONS. DURING MANUFACTURING, SUTURE STRENGTH IS TESTED. IN ADDITION, SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. THE SUTURE MAY BREAK IF THE USER APPLIES TOO MUCH TENSION WHILE PULLING ON THE LIMB SUTURE. THE DEVICE MAY BECOME DIFFICULT TO REMOVE DUE TO: POSTERIOR CUFF PARTIALLY DEPLOYED IN FOOT, TANGLED SUTURE IF FULL STROKE OF PLUNGER WITHDRAWAL IS NOT COMPLETED, EDGING OF THE DEVICE THAT CAN CATCH THE ARTERIAL WALL, OR REMOVAL OF THE DEVICE BEFORE THE SUTURE RETRIEVAL. TISSUE CAUGHT IN THE FOOT (DUE TO ANATOMICAL CONDITIONS) CAN PREVENT IT FROM COMPLETELY RETRACTING AND CAN MAKE DEVICE WITHDRAWAL DIFFICULT. OTHER ANATOMICAL INFORMATION OR PATIENT MEDICAL HISTORY WAS NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE AFTER A DIAGNOSTIC PROCEDURE USING A 6F SHEATH. REPORTEDLY, DURING DEVICE RETRACTION, EVEN THOUGH THE FOOT WAS CLOSED COMPLETELY, RESISTANCE WAS ENCOUNTERED. MULTIPLE ATTEMPTS TO REMOVE THE DEVICE WERE UNSUCCESSFUL. A VASCULAR SURGEON WAS CALLED TO SURGICALLY REMOVE THE DEVICE, BUT THE DEVICE WAS SUCCESSFULLY REMOVED BY INCREASING THE ANGLE OF THE DEVICE TO THE GROIN. THERE WAS NO SURGICAL INTERVENTION NECESSARY AND HEMOSTASIS WAS ACHIEVED BY THE DEVICE. IT WAS ALSO REPORTED THAT THE PHYSICIAN EXPRESSED DISCOMFORT WHILE RETRACTING THE PLUNGER, HE STATED THAT IT FELT 'GRITTY'. THE SUTURE REPORTEDLY SNAPPED DURING PLUNGER RETRACTION, BUT THE PHYSICIAN WAS ABLE TO GRAB THE SUTURE AND TIE THE KNOT TO COMPLETE THE CLOSURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE PERCLOSE 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 060156H

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention SHEATH: 6F