BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2082381 · Received May 9, 2011

    Report

    Report Number
    2024168-2011-03326
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    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 HAS BEEN 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 APPROXIMATELY 2 INCHES OF THE MONOFILAMENT WAS EXPOSED AT THE GUIDE AND THE POSTERIOR CUFF AND NEEDLE TIP WERE STILL ATTACHED TO THE RAIL END. THE REST OF THE MONOFILAMENT WAS PULLED FROM THE DEVICE WITHOUT RESISTANCE. BASED ON THE INVESTIGATION FINDINGS, THE LINK WAS PULLED FROM 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 COULD APPEAR SIMILAR TO A CUFF MISS. DURING STEP #3 (REMOVING THE PLUNGER FROM THE BODY OF THE DEVICE) 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 OR BREAK. A LINK PULL CAN BE INFLUENCED BY MANY FACTORS LIKE EXCESSIVE TENSION DURING PLUNGER RETRACTION BY AGGRESSIVELY REMOVING THE PLUNGER AND EXCESSIVE FORCE CAN BE CAUSED BY HIGH FRICTION AGAINST THE SUTURE DUE TO CHALLENGING ANATOMIES (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.). THERE WAS NO PRODUCT QUALITY DEFICIENCY DETECTED THAT WOULD CONTRIBUTE TO THIS EVENT; THEREFORE, THE CAUSE FOR THE LINK BREAK FROM THE CUFF COULD NOT BE DETERMINED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC 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 THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 020156H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention