BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3231169 · Received July 17, 2013

    Report

    Report Number
    2024168-2013-04485
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 26, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE ANALYSIS OF THE RETURNED DEVICE DID NOT CONFIRM THE REPORTED CUFF MISS. THE LINK WAS PULLED FROM THE SWAGE-END OF THE POSTERIOR CUFF. THE LINK CONNECTS THE ANTERIOR NEEDLE TO THE SUTURE; IF THE LINK IS PULLED FROM THE CUFF, THE SUTURE WILL NOT BE PRESENT DURING PLUNGER WITHDRAWAL AND CAN APPEAR VERY SIMILAR TO A CUFF MISS. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THE CAUSE OF THE INCIDENT WAS RELATED TO THE OPERATIONAL CONTEXT AT TIME OF USE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE SAFETY AND EFFECTIVENESS OF THE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED FOR PATIENTS WHO ARE MORBIDLY OBESE (BODY MASS INDEX GREATER THAN 40 KG/M). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE WITH A 7FR SHEATH, AFTER A PERIPHERAL INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. A SECOND PROGLIDE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330982 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30521K1

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention SHEATH: 7F, HEPARIN