BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3002709 · Received March 13, 2013

    Report

    Report Number
    2024168-2013-01445
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 20, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE OTHER PERCLOSE PROGLIDE DEVICES REFERENCED ARE FILED UNDER SEPARATE MEDWATCH MANUFACTURER REPORT NUMBERS.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE NEEDLE PLUNGER, NEEDLES, CUFFS, AND LINK WERE NOT RETURNED WITH THE DEVICE; THEREFORE, THE REPORTED EXPERIENCE OF THE NEEDLES RETURNING WITHOUT THE SUTURE COULD NOT BE CONFIRMED. HOWEVER, THE ANALYSIS OF THE RETURNED DEVICE INDICATED THAT A PORTION OF THE POSTERIOR FOOT WAS BROKEN OFF AND WAS NOT RETURNED. BASED ON VISUAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN UNSPECIFIED PROCEDURE, ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL WAS ATTEMPTED USING THREE PERCLOSE PROGLIDE DEVICES. REPORTEDLY, AFTER DEPRESSING THE NEEDLE PLUNGER TO DEPLOY THE NEEDLES, WHEN THE NEEDLE PLUNGER WAS REMOVED, THE NEEDLES RETURNED WITHOUT THE SUTURE. A FOURTH PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: EVALUATION OF THE RETURNED PROGLIDE DEVICE FOUND THAT THE POSTERIOR FOOT POCKET WAS BROKEN OFF AND WAS NOT RETURNED. THE REPORTER WAS CONTACTED, BUT WAS UNABLE TO PROVIDE ANY FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105531 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20723J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention