BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2031925 · Received March 28, 2011

    Report

    Report Number
    2024168-2011-02069
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    February 25, 2011
    Report Date
    March 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT IT WAS PARTIALLY DEPLOYED. BOTH CUFFS HAD BEEN CAPTURED AND THE POSTERIOR CUFF WAS ATTACHED TO THE NEEDLE TIP. HOWEVER, THE LINK WAS PULLED FROM THE POSTERIOR CUFF DURING SUTURE HARVESTING. A LINK BREAK DURING NEEDLE RETRIEVAL AND A CUFF MISS HAVE THE SAME RESULT AND APPEARANCE DURING DEPLOYMENT; THEREFORE, THE REPORTED EXPERIENCE IS CONFIRMED. THE OTHER COMPONENTS WERE NORMAL AND UNDAMAGED. AFTER NEEDLE DEPLOYMENT, THE SUTURE IS HARVESTED AND PULLED THROUGH THE SUTURE BEARING AND ANTERIOR NEEDLE GUIDE; RESISTANCE AT THIS POINT OF DEPLOYMENT CAN CAUSE THE LINK TO DETACH. A LINK DETACHMENT CAN BE INFLUENCED BY MANY FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING, FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45 DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATING THE DEVICE AT ANY POINT DURING PLUNGER/NEEDLE DEPLOYMENT, DEPLOYMENT IN CHALLENGING ANATOMIES (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.), AGGRESSIVELY DEPLOYING OR REMOVING THE PLUNGER AND/OR INADEQUATE POSITIONING OF THE FOOT AGAINST THE ARTERIAL WALL. BASED ON THE ANALYSIS THE PROBABLE CAUSE OF THE LINK DETACHMENT IS RELATED TO THE OPERATIONAL CONTEXT DURING USE. THERE WAS NO PRODUCT QUALITY DEFICIENCY DETECTED THAT WOULD CONTRIBUTE TO THIS EVENT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. EACH COMPONENT IS INSPECTED DURING MANUFACTURING AND EACH FINISHED GOODS LOT IS INSPECTED BY SAMPLING.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. ESTIMATE AGE. PATIENT WAS REPORTED TO BE (B)(6). 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 A TECHNICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, UPON PLUNGER REMOVAL, THE SUTURE KEPT PULLING OUT. A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 950386H

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention