BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2151876 · Received July 6, 2011

    Report

    Report Number
    2024168-2011-04784
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 15, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED WITH ALL COMPONENTS IN PRE-DEPLOYED POSITIONS AND THE RETURNED CONDITION SUBSTANTIATED THE REPORTED PRODUCT EXPERIENCE. DRIED BLOOD WAS OBSERVED THROUGHOUT THE DEVICE, INDICATING THAT THE DEVICE WAS INTRODUCED INTO THE PATIENT ANATOMY AS REPORTED. PRIOR TO DECONTAMINATION AND DURING LAB TESTING THE LUMINAL MARKING TEST FAILED. THE DEVICE WAS DISASSEMBLED FOR INTERNAL INSPECTION AND EXCESSIVE DRIED BLOOD AND OTHER BIOLOGICAL MATTERS WERE FOUND OCCLUDING THE INNER MARKER LUMEN; AS SUCH, FURTHER MARKER LUMEN TESTING COULD NOT BE PERFORMED. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR THE MARKER LUMEN BLOCKAGE IS DUE TO A BLOOD CLOT OR OTHER BIOLOGICAL MATTERS. NO MANUFACTURING OR QUALITY DEFICIENCIES WERE DETECTED. THE MARKER LUMEN PATENCY TEST WAS PERFORMED ON EVERY DEVICE DURING MANUFACTURING. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED FOR THIS LOT AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THE PROBABLE CAUSE FOR THE DETECTED MARKER LUMEN BLOCKAGE WAS DETERMINED TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE OF THE DEVICE AND NOT A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THERE WAS NO PULSATILE BLOOD FLOW NOTED FROM THE MARKER LUMEN. THE DEVICE WAS FLUSHED SEVERAL TIMES WITHOUT DIFFICULTY; HOWEVER, NO BLOOD FLOW WAS NOTED IN THE MARKER LUMEN. HEMOSTASIS WAS ACHIEVED USING A NON-ABBOTT DEVICE. THERE WAS NO ADVERSE PATIENT SEQUELA. REPORTEDLY THE PHYSICIAN IS PROFICIENT 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 030426H

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention SHEATH: 7F