BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2250860 · Received September 16, 2011

    Report

    Report Number
    2024168-2011-06341
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. WITHOUT THE DEVICE ANALYSIS, A CAUSE FOR THE DIFFICULT TO REMOVE AND DEVICE BREAKAGE COULD NOT BE DETERMINED. DIFFICULTY REMOVING THE DEVICE, WHICH IS THE LIKELY CAUSE FOR THE REPORTED DEVICE BREAKAGE, CAN BE INFLUENCED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING, USER TECHNIQUE AND/OR PATIENT ANATOMICAL CONDITIONS. DURING MANUFACTURING, DEVICES ARE VISUALLY INSPECTED AND A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. RELATED TO USER TECHNIQUE, THE DEVICE MAY BECOME DIFFICULT TO REMOVE DUE TO, POSTERIOR CUFF PARTLY DEPLOYED IN FOOT, SUTURE TANGLED DUE TO OPERATOR NOT COMPLETING FULL STROKE OF PLUNGER WITHDRAWAL, DEVICE EDGES CATCHING ARTERY WALL, OR DEVICE REMOVED BEFORE THE SUTURE WAS PULLED OUT OF DEVICE. TISSUE CAUGHT IN FOOT DUE TO ANATOMICAL CONDITIONS COULD CAUSE IT NOT TO COMPLETELY RETRACT CAN MAKE DEVICE WITHDRAWAL DIFFICULT. 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 FOR THIS LOT REVEALED NO OTHER INCIDENTS REPORTED FOR DIFFICULT TO REMOVE/BREAKAGE OF DEVICE. BASED ON THE DEVICE LOT HISTORY RECORD, DATABASE REVIEWS, AND TESTING CRITERIA FOR THIS DEVICE LOT, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. WITHOUT THE DEVICE ANALYSIS, A CAUSE FOR THE DIFFICULT TO REMOVE AND DEVICE BREAKAGE COULD NOT BE DETERMINED. THE REPORTED PIECE OF PLASTIC (THOUGHT TO BE THE FOOT) FOUND IN THE ARTERY DURING SURGICAL CLOSURE, INDICATES THAT MOST LIKELY A FOOT BREAK OCCURRED DURING DEPLOYMENT. A FOOT BREAK CAN BE INFLUENCED BY, BUT IS NOT LIMITED TO, MANUFACTURING, USER TECHNIQUE AND/OR PATIENT ANATOMICAL CONDITIONS. DURING MANUFACTURING, DEVICES ARE VISUALLY INSPECTED AND A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. THE PATIENTS ANATOMICAL CONDITION, SUCH AS OBESITY AND/OR CALCIFICATION, CAN INTERFERE WITH NEEDLE DEPLOYMENT, CAUSING THE NEEDLE TO DEFLECT AND STRIKE THE FOOT BREAKING IT. TISSUE TRAPPED UNDER THE FOOT DURING DEPLOYMENT CAN CAUSE INTERFERENCE AND MAY BREAK THE FOOT. ALSO, THE FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT DURING DEPLOYMENT CAN PUT PRESSURE ON THE FOOT CAUSING IT TO BREAK. THE REPORTED DIFFICULTY REMOVING THE DEVICE MAY BE EXPERIENCED WHEN RESISTANCE AGAINST THE FOOT PREVENTS PARKING (CLOSURE) OF THE FOOT PRIOR TO REMOVAL. BASED ON THE REPORTED INFORMATION AND THE INSPECTION CRITERIA, THE CAUSE FOR THE REPORTED DIFFICULT REMOVAL AND DEVICE BREAKAGE APPEARS TO BE RELATED TO THE OPERATIONAL INFLUENCES DURING USE AND NOT A PRODUCT QUALITY DEFICIENCY. REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEALED ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED NO PREVIOUS INCIDENTS REPORTED FOR A DIFFICULT TO REMOVE OR BREAKAGE OF DEVICE AND THERE DOES NOT APPEAR TO BE ANY 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 OTHER PERCLOSE PROGLIDE DEVICE IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF RIGHT AND LEFT COMMON FEMORAL ARTERIOTOMIES WAS ATTEMPTED USING PERCLOSE PROGLIDE DEVICES AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED WITH THE DEVICE USED ON THE RIGHT SIDE AND ANOTHER PROGLIDE WAS USED TO ACHIEVE HEMOSTASIS. AFTER A PROGLIDE WAS DEPLOYED ON THE LEFT SIDE, THE DEVICE COULD NOT BE REMOVED AND WAS PULLED OUT. DURING THE SURGICAL CLOSURE, A PIECE OF PLASTIC, THOUGHT TO BE THE FOOT WAS FOUND IN THE ARTERY AND WAS REMOVED. THERE WAS NO ADVERSE PATIENT SEQUELA. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE. 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 060326H

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention SHEATH: 6F