BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2143142 · Received June 28, 2011

    Report

    Report Number
    2024168-2011-04531
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND IT WAS PARTIALLY DEPLOYED WITH BLOOD PRESENT IN THE DEVICE. THE FOOT WAS NOT FULLY PARKED DUE TO THE ENTANGLED TISSUE DETECTED AT THE ANTERIOR FOOT PREVENTING FROM COMPLETELY PARKING. THE TISSUE ENTANGLED AT THE POSTERIOR NEEDLE TIP INDICATES THE TISSUE CAPTURE OCCURRED DURING DEVICE INSERTION. THE SLACK DETECTED AT THE LINK INDICATES THE FOOT WAS OPENED AT SOME POINT AND POSSIBLY IN THE TISSUE TRACK. TISSUE CAPTURE PRIOR TO NEEDLE DEPLOYMENT IS GENERALLY ASSOCIATED WITH THE PATIENT ANATOMICAL CONDITIONS AND OR INCORRECT DEPLOYMENT SEQUENCES AND NOT PRODUCT QUALITY. BASED ON THE EVALUATION, THE REPORT OF THE DEVICE OPERATING DIFFERENTLY CANNOT BE CONFIRMED; HOWEVER, DURING DEPLOYMENT TESTING THE POSTERIOR CUFF FAILED TO ADHERE TO THE NEEDLE TIP DUE TO THE ENTANGLED TISSUE AROUND THE NEEDLE TIP. THE ANALYSIS DID NOT INDICATE A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. IN ADDITION A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE WAS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. BASED ON THE TEST ANALYSIS AND THE REPORTED INFORMATION, A CONCLUSIVE CAUSE FOR THE UNSPECIFIED COMPLAINT COULD NOT BE DETERMINED. TO ASSURE DEVICES OPERATE ACCORDING TO SPECIFICATION, EACH DEVICE INSPECTED DURING MANUFACTURING AND A QUALITY CONTROL AUDIT IS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY WAS ATTEMPTED USING THE PERCLOSE PROGLIDE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE CUSTOMER COMPLAINED ABOUT THE DEVICE, BUT DID NOT PROVIDE THE DETAILS ABOUT THE COMPLAINT. THE METHOD USED TO ACHIEVE HEMOSTASIS AND THE STATUS OF THE PATIENT WERE NOT PROVIDED. REPORTEDLY, THE PHYSICIAN IS TRAINED IN THE USE OF THE DEVICE. 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 920256H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention