BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2191281 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05481
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 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 PROGLIDE NOTED THAT THE LINK HAD BEEN BROKEN AT THE POSTERIOR CUFF. A LINK BREAK CAN RESULT IN A FAILURE TO RETRIEVE THE SUTURE DURING PLUNGER REMOVAL AND HAVE SAME RESULT AND APPEARANCE AS THE REPORTED NEEDLE TO CUFF MISS. BECAUSE THE DEVICE WAS RECEIVED WITH BOTH CUFFS ATTACHED TO THE NEEDLE TIPS DURING DEPLOYMENT THE REPORT OF CUFF MISS CAN NOT BE CONFIRMED. THE LINK DETACHMENT IN THIS CASE PREVENTED SUTURE RETRIEVAL RESULTING IN THE PATIENT AFFECT OF HEMORRHAGE REQUIRING THE USE OF ADDITIONAL DEVICE TO ACHIEVE CLOSURE AS REPORTED. THE CONDITION OF THE DEVICE INDICATES THE LINK WAS BROKEN DURING PLUNGER REMOVAL. THE ANALYSIS DID NOT INDICATE A PRODUCT DEFICIENCY. THE LINK BREAK CAN BE INFLUENCED BY BUT NOT LIMITED TO EXCESSIVE FORCE DURING PLUNGER REMOVAL, JERKY MOTION OR A SIDE WALL STICK, DEPLOYMENT IN CHALLENGING ANATOMIES (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.) AND MANUFACTURING. IT SHOULD BE NOTED THE INSTRUCTIONS FOR USE (IFU) STATES DURING THIS STEP: PULL BACK ON THE PLUNGER UNTIL THE SUTURE IS PULLED TAUT. A REVIEW OF THE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT-SPECIFIC PRODUCT QUALITY DEFICIENCY. SINCE THE DEVICE PREFORMED ACCORDING TO SPECIFICATIONS, THE POSSIBLE CAUSE FOR THIS COMPLAINT IS UNDETERMINED. BASED ON THE INVESTIGATION AND REVIEW OF THE REPORTED EXPERIENCE THE DETACHMENT OF THE LINK DURING USE APPEARS TO BE RELATED TO THE OPERATIONAL INFLUENCES DURING USE AND NOT A PRODUCT QUALITY DEFICIENCY. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT INSPECTION DURING MANUFACTURING, THE LINK ASSEMBLY OF EACH DEVICE IS INSPECTED 100%. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DIAGNOSTIC PERCUTANEOUS PERIPHERAL CATHETERIZATION THROUGH A 6F PROCEDURAL SHEATH, ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, A NEEDLE-TO-CUFF MISS OCCURRED. WHEN THE NEEDLE PLUNGER WAS REMOVED FROM THE BODY OF THE DEVICE, THERE WAS NO SUTURE ATTACHED TO THE NEEDLE. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. 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 030126H

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention PROCEDURAL SHEATH 6F