BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2101301 · Received May 24, 2011

    Report

    Report Number
    2024168-2011-03676
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 29, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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 WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THAT BOTH CUFFS WERE STILL ATTACHED TO THE LINK AND RESPECTIVE NEEDLE TIPS. THERE WAS ABOUT 3/4 INCHES OF MONOFILAMENT STILL ATTACHED TO THE NEEDLE TIP AND THE REST OF THE MONOFILAMENT WAS NOT RETURNED. THE GUIDE TUBE WAS PEELED AND THERE WAS NO ABNORMAL OBSERVATION WITH THE CONDITION OF THE RETURNED DEVICE THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. WE WERE UNABLE TO DETERMINE THE CAUSE OR CONFIRM THE EXPERIENCE OF SUTURE BROKE WHEN THE KNOT WAS BEING TIGHTENED BASED ON THE CONDITION OF THE RETURNED DEVICE BECAUSE THE MONOFILAMENT WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. TO HELP ENSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. BASED ON THE INFORMATION AVAILABLE, THE INSPECTION CRITERIA AND THE REVIEW OF THE LOT HISTORY RECORD, THERE WAS NO INDICATIONS OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE PROGLIDE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY AFTER A CORONARY INTERVENTIONAL PROCEDURE. REPORTEDLY, THE SUTURE BROKE WHEN THE KNOT WAS BEING TIGHTENED USING THE SUTURE TRIMMER. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO ADVERSE PATIENT EFFECTS. 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 010486H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention