BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2020379 · Received March 16, 2011

    Report

    Report Number
    2024168-2011-01760
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 ANTERIOR 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 OF NO SUTURE PRESENT DURING PLUNGER REMOVAL IS CONFIRMED. DURING NEEDLE TRAJECTORY TESTING THE ORIGINAL PLUNGER WAS RE-INSERTED INTO THE DEVICE AND THE TRAJECTORY, DEPTH AND MANDREL TRAVEL WERE ACCEPTABLE AND NOT A CONTRIBUTING FACTOR IN THE EVENT. DURING STEP # 3 (PLUNGER AND NEEDLES REMOVAL FROM THE DEVICE BODY) THE SUTURE IS HARVESTED AND PULLED THRU 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 ROOT 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. THE NEEDLE TRAJECTORY OF EACH DEVICE IS INSPECTED TWICE DURING MANUFACTURING. A REVIEW OF THE FINISHED LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (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 PHYSICIAN, TRAINED IN THE USE OF THE PROGLIDE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING PLUNGER REMOVAL NO SUTURE WAS PRESENT ON THE NEEDLES. THE PROGLIDE DEVICE WAS REMOVED AND A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT EFFECT. 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 940226H

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention OTHER: ANGIOMAX